Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\r\n* Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician; patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the study physician
The participant has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except =< grade 2 alopecia, neuropathy, and other non-clinically significant adverse events (AEs)
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5) grade =< 1 (except alopecia) at the time of enrollment
Nervous system disorders (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0) resulting from prior therapy must be =< grade 2 with the exception of decreased tendon reflex (DTR); any grade of DTR is eligible
Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v]4) resulting from prior therapy must be =< grade 2
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or baseline, with the exception of alopecia)
Resolution of all acute AEs resulting from prior cancer therapies to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) grade ? 1 or to that patient's pre-study baseline (except alopecia or neuropathy)
Nervous system disorders (Common Terminology Criteria for Adverse Events version 4 [CTCAE v4]) resulting from prior therapy must be =< grade 2
Any pre-existing medical condition that would represent toxicity in excess of grade 1 as measured by CTCAE (National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events version 4.03) unless the symptom is not considered medically significant by the treating investigator (e.g., alopecia)
Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) resulting from prior therapy must be =< grade 2, with the exception of decreased tendon reflex (DTR); any grade of DTR is eligible
No ongoing cardiac dysrhythmias of grade >= 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, uncontrolled atrial fibrillation (any grade), or corrected QT (QTc) interval > 470 msec
Patients with active >= Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4 grade 2 neuropathy are ineligible
STEP I: Patients must not have grade 2 or higher peripheral neuropathy by Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Patients must have completed prior chemotherapy, immunotherapy, or radiation therapy at least 14 days prior to step 2 randomization and all toxicity must be resolved to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 1 (with the exception of CTCAE v4.0 grade 2 neuropathy) prior to step 2 randomization
Patients should have resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, grade 1 or less
Persistent toxicities (>= Common Terminology Criteria for Adverse Events [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia and CTCAE grade 2 peripheral neuropathy
Recovered from adverse events to grade 1 or less toxicity according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE 4.0) due to agents administered previously\r\n* NOTE: Chemotherapy-induced alopecia and grade 2 neuropathy are acceptable
Diarrhea >= grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) categorization within 14 days of registration
Absolute neutrophil count (ANC) >= 1,500/mm^3 , equivalent to Common Toxicity Criteria (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 3.0) grade 1
No unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2, prior platinum-therapy–related neuropathy
Patients should have resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, grade 1
Symptomatic peripheral sensory neuropathy >= grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.0) in patients with no prior oxaliplatin therapy
Patients may have received prior surgery; all adverse events associated with prior surgery must have resolved to =< grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] 4.0) prior to registration
Patients requiring hearing aids or reporting hearing loss must have audiogram performed within 28 days prior to step 1 registration; if audiogram is performed, patient must not have hearing impairment >= Common Terminology Criteria for Adverse events (CTCAE) grade 2
Patients must not have Common Terminology Criteria for Adverse Events (CTCAE) >= grade 2 neuropathy (cranial, motor or sensory) within 14 days prior to registration
Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4) resulting from prior therapy must be =< grade 2
Nervous system disorders (by Common Terminology Criteria for Adverse Events version 5.0 [CTCAE V 5.0]) resulting from prior therapy must be =< grade 2, with the exception of decreased tendon reflex (DTR); any grade of DTR is eligible
Patients who have received prior treatment with anti-CTLA-4 may be enrolled, provided the following requirements are met: minimum of 12 weeks from the first dose of anti-CTLA-4 and > 6 weeks from the last dose, and no history of severe immune-related adverse effects from anti-CTLA-4 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] grade 3 and 4)
Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade < 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study)
Any ongoing toxicity from prior anti-cancer treatment that, in the judgment of the investigator, may interfere with study treatment; all toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must resolve to grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4) or baseline prior to registration
Patient has Common Toxicity Criteria for Adverse Effects (CTCAE) v 4.0 grade ? 2 hemorrhage
Diarrhea, grade 1 or greater by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version [v] 4.0)
Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, surgery to =< grade 1 per National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (NCI CTCAEv4) except neuropathy which may be =< grade 2
All prior anti-cancer treatment-related toxicities (except alopecia and laboratory values as listed above) must be =< grade 1 according to the Common Terminology Criteria for Adverse Events version 4 (CTCAE version 4.03, 2009) at the time of starting treatment
Recovered from all toxicities associated with prior treatment, to acceptable baseline status or a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4, grade of 0 or 1, except for toxicities not considered a safety risk, such as alopecia or vitiligo
Symptomatic peripheral neuropathy >= grade 2 Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 (for participants receiving docetaxel only)
Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicities see below limits for inclusion) or a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03, Grade of 0 or 1, except for toxicities not considered a safety risk (eg, alopecia or vitiligo).
Persistent toxicities (>= Common Terminology Criteria for Adverse Events [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia
Peripheral sensory neuropathy >/= Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
Pre-existing, clinically significant peripheral neuropathy, defined as Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher neurosensory or neuromotor toxicity, regardless of etiology
With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment
Presence of grade >= 2 Common Terminology Criteria for Adverse Events (CTCAE) toxicity (CTCAE grade 2 peripheral neuropathy and ototoxicity and any grade alopecia are allowed)
Clinically active infection as judged by the site investigator (>= grade 2 by Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4)
Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or less toxicity from other agents with exception of alopecia and fatigue
Residual toxicity from prior therapy grade > 1 (National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.0) that could interfere with study endpoints or put patient safety at risk
Subjects with >= grade 2 peripheral neuropathy at enrollment per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Failure to recover from all adverse events/toxicities related to prior anticancer therapies to grade 1 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03; NOTE: Exception: patients with any grade of alopecia are allowed to enter the study
Patients who have not recovered to < Common Terminology Criteria for Adverse Events (CTCAE) grade 2 toxicities related to prior therapy are ineligible
Participant has unresolved, clinically significant toxicities from prior anticancer therapy, defined as greater than Grade 1 on Common Terminology for adverse events.
Clinically significant toxicity (other than alopecia) from prior therapy that has not resolved to Grade less than or equal to (</=) 2 (according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0) prior to Day 1 of Cycle 1
National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade 3 or higher toxicities due to any prior therapy (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication
Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
EXCLUSION CRITERIA FOR SECOND-LINE THERAPY: Clinically significant peripheral neuropathy at the time of enrollment (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v4.0] as grade 2 or greater neurosensory or neuromotor toxicity)
EXCLUSION CRITERIA FOR THIRD-LINE THERAPY: Clinically significant peripheral neuropathy at the time of enrollment (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v4.0] as grade 2 or greater neurosensory or neuromotor toxicity)
Patients who have received prior treatment with anti-CTLA-4 antibody may be enrolled, provided the following requirements are met:\r\n* > 6 weeks from the last dose\r\n* No history of severe immune-related adverse effects from anti-CTLA-4 antibody (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] grade 3 and 4)
Persistent diarrhea or malabsorption National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 2, despite medical management
History of high grade (Common Terminology Criteria for Adverse Events [CTCAE] >= grade 3) immune mediated adverse event from prior cancer immunotherapy
Moderate-to-severe bone pain (i.e., National Cancer Institute's Common Terminology Criteria for Adverse Events grade 2-3 bone pain).
Has had chemotherapy, radiation or biological cancer therapy within 4 weeks prior to the first dose of study drug, or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 0 or 1 from the AEs due to cancer therapeutics administered more than 4 weeks earlier (this includes participants with previous immunomodulatory therapy with residual immune-related [ir]AEs).
Participants who have had chemotherapy within 14 days prior registration or those who have not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade =< 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study); there is no washout period required for trastuzumab or for endocrine therapy; however subjects who received fulvestrant immediately prior to this trial should wait at least 28 days before receiving their first dose of fulvestrant on study
Prior treatment-related adverse events (AEs) must be =< grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] v4.0), except alopecia, at time of initiating study drug
Prior locoregional liver directed therapy is allowed as long as treatment was at least 6 weeks prior to study registration, and clear progression is demonstrated by RECIST v1.1 criteria; subject must have recovered from the acute toxic effects (=< grade 1 Common Terminology Criteria for Adverse Events [CTCAE] v4) of previous anti-cancer treatment prior to study enrollment; the only exception is that grade 2 neuropathy is permitted
Thyroid function abnormality ? Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2.
Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 to less than or equal to grade 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study)
Patients with gastrointestinal bleeding or any other hemorrhage/bleeding event Common Terminology Criteria for Adverse Events (CTCAE) grade >= 3 within 30 days prior to study entry
Failure to recover (to Common Terminology Criteria for Adverse Events [CTCAE Version 4.0] Grade 0 or Grade 1) from acute non-hematologic toxicity (except alopecia or Grade 2 or lower neuropathy), due to previous therapy, prior to Screening.
Neuropathy >= grade 3 or painful neuropathy >= grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version [v]4.03)
Presence of an acute or chronic toxicity of prior chemotherapy, with the exception of alopecia, that has not resolved to ?Grade 1, as determined by National Cancer Institute Common Toxicity Criteria for Adverse Effects (CTCAE) v 4.0 (http://evs.nci.nih.gov/ftp1/CTCAE/About.html).
Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v. 5.0) grade 2 or higher from previous anti-cancer therapy, except alopecia, at the time of randomization
For patients with newly diagnosed ovarian/tubal/peritoneal cancer who have received pre-operative neoadjuvant chemotherapy, evidence of response must be documented by at least one of the following:\r\n* Decline in serum cancer antigen (CA) 125 level\r\n* At least a 30% decrease in the sum of the longest diameter of target lesions on radiographic imaging\r\n* Improvement of ascites volume\r\n* Neoadjuvant chemotherapy must be held for at least 3 weeks prior to surgery\r\n* Resolution of any effects of prior therapy (except alopecia and peripheral neuropathy) to the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) grade =< 1 and to baseline laboratory values as defined
Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) grade 1
Peripheral neuropathy of Grade greater than or equal to (>/=) 3 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0 or 4.0, as utilized in the parent study
Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v).4.0 from toxicities related to any prior treatments, unless adverse events (AEs) are clinically nonsignificant and/or stable on supportive therapy
All prior anti-cancer treatment-related toxicities (except alopecia and laboratory values) must be =< grade 1 according to the Common Terminology Criteria for Adverse Events version 4 (CTCAE version 4.0) at the time of randomization
Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of AG-270, including any unresolved nausea, vomiting, or diarrhea that is National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >1.
Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment
Participant has unresolved toxicities from most recent prior anti-cancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE v 4.03) grade 2 or higher clinically significant toxicity (excluding alopecia).
Toxicities of prior therapy must be resolved to grade 1 or less as per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy
PHASE II INCLUSION CRITERIA: Toxicities of prior therapy must be resolved to grade 1 or less as per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy
Has sensory or motor neuropathy of >= National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) Grade 3.
Recovery from all prior surgical or adjuvant treatment-related toxicities, to baseline status, or a Common Terminology Criteria for Adverse Events (CTCAE) grade of 0 or 1, except for toxicities not considered a safety risk, such as alopecia; post-surgical pain will not be considered a basis for exclusion
Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment
Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 grade =< 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study)
Participants who have not recovered to =< Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or baseline from toxicity as a result of previous cancer treatment prior to entering the study (with the exception of alopecia and peripheral neuropathy which can be =< grade 2)
Persistent grade > 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0) adverse events (AEs) due to investigational drugs that were administered more than 14 days before registration
At least 2 weeks must have elapsed since the end of prior chemotherapy, biological agents (4 weeks for anti-cancer monoclonal antibody containing regimens) or any investigational drug product, with adequate recovery of treatment-related toxicity to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =< 1 (or tolerable grade 2) or back to baseline (except for alopecia or neuropathy); any number of prior therapies for recurrent/metastatic ACC are allowed, with the exception of previous treatment with PD-1 pathway inhibitors
Participants who have had chemotherapy, biologic therapy, or investigational therapy within 21 days (including bevizumab) or radiotherapy within 7 days prior to entering the study or those who have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 or baseline from adverse events due to agents administered
Recovered from adverse events (to grade 1 or less toxicity according to Common Terminology Criteria for Adverse Events [CTCAE] 4.0) due to agents administered previously; NOTE: chemotherapy-induced alopecia and grade 2 neuropathy are acceptable
Less than 3 days from prior treatment with EGFR TKI; patients with adverse events related to prior EGFR TKI must recover to Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 to be eligible
All non-hematological adverse events related to any prior chemotherapy, surgery, or radiotherapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade less than or equal to (</=) 2 prior to starting therapy Alectinib
The participant has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
Neurologic function: neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE), Grade 1, at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4.03), grade =< 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia
Prior systemic treatment is allowed, but toxicities of prior therapy must be resolved to grade 1 or less as per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Persisting toxicity related to prior therapy > Grade 1 National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 (NCI-CTCAE v4.03); however, sensory neuropathy ? Grade 2 is acceptable.
Any toxicity due to prior therapy that has not been resolved to less than Grade 2 severity by Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03 or higher) criteria
All previous therapies for cancer, including radiotherapy, major surgery and investigational therapies discontinued for ? 14 days (? 28 days for mitomycin C or nitrosoureas) before study entry, and all acute effects of any prior therapy resolved to baseline severity or Grade ? 1 Common Terminology Criteria for Adverse Events (CTCAE v4.03), except alopecia or parameters defined in this eligibility list.
Have discontinued previous treatments for cancer and have resolution, except where otherwise stated in the inclusion criteria, of all clinically significant toxic effects of prior chemotherapy, surgery, or radiotherapy to Grade ?1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
All acute toxic effects of any prior treatment have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 4.0 grade 1 or less at the time of signing the informed consent form (ICF) except for alopecia
Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4), grade =< 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Has pre-existing peripheral neuropathy that is ? Grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria.
Diarrhea > grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03
Must have received prior therapy with a MET inhibitor; patients must have recovered from all toxicities related to prior anticancer therapies to grade =< 1 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.0); patients with any grade of alopecia are allowed to enter the study
Recovery from all adverse events (AEs) of previous anti-cancer therapies, including surgery, chemotherapy and radiotherapy, to baseline or to Common Terminology Criteria for Adverse Events (CTCAE) grade =< 1, except for alopecia
Diarrhea > grade 1, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading, in the absence of antidiarrheals
Resolution of all acute toxic effects of prior chemotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade < 1, in the opinion of the treating physician
Subject has proteinuria defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version [v] 4.0) grade > 1 at baseline as measured by a urine dipstick (2+ or greater) and confirmed by a 24 hour urine collection (>= 1 g/24 hrs); subjects may be re-screened if proteinuria is shown to be controlled with or without intervention
Patients must be recovered from any toxicity related to prior anti-neoplastic therapy (to grade < 1); patients with Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or less sensory neuropathy or any grade alopecia are eligible
For subjects with muscle invasive disease: not suitable neoadjuvant cisplatin­based chemotherapy as determined by the following:\r\n* Creatinine clearance less than 60 ml/min\r\n* Common Terminology Criteria for Adverse Events (CTCAE) grade (gr) >= 2 hearing loss\r\n* CTCAE gr >= 2 neuropathy
Lack of recovery of prior adverse events due to prior cancer therapy to grade =< 1 (NCI Common Terminology Criteria for Adverse Events [CTCAE]; except alopecia); electrolyte abnormalities that are corrected with supplementation will be eligible; patients with platinum-related grade 2 or greater hypomagnesemia (on replacement) will be eligible; stable persistent grade 2 peripheral neuropathy may be allowed as determined on a case-by-case basis at the discretion of the principal investigator (PI)
Have any reported baseline lab values with a grade 3 or 4 toxicity as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
The subject has not recovered to baseline, Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies for RCC or to a level permitted under other sections of the eligibility criteria except alopecia and other non-clinically significant adverse events (AEs)
History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias > Grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0), thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (eg, pericardial effusion restrictive cardiomyopathy) within 6 months prior to first dose of study drug. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
Diarrhea > grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading, in the absence of antidiarrheals
Subjects must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as >= Common Toxicity Criteria [CTC] grade 2 [Common Terminology Criteria for Adverse Events (CTCAE) version 4.0])
Patient must not have any active, uncontrolled cardiac, hepatic, renal, or psychiatric disease defined as >= grade 3 based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version (v)4.0 (CTCAE)
Recovery from acute toxicity of prior treatment for RCC (to =< grade 1 the active version of Common Terminology Criteria for Adverse Events [CTCAE] or to a level permitted under other sections of inclusion/exclusion criteria)
Any abnormality that would be scored as National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (v 3.0) grade IV toxicity that is unrelated to HIV, its treatment, or to MCD that would preclude protocol treatment and/or observation only
Inadequate recovery from toxicity attributed to prior anti-cancer therapy.\r\n* With the exception of alopecia, fatigue, or peripheral neuropathy, patients must have recovered to =< grade 1 (National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version [v] 4.03) residual toxicity prior to first dose of protocol-indicated treatment.
Concurrent disease or condition that would interfere with study participation or safety, such as any of the following: \r\n* Active, clinically significant infection either grade > 2 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 or requiring the use of parenteral anti-microbial agents within 14 days before day 1 of study drug.\r\n* Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders non-healing wound, ulcer, or bone fracture.
All acute toxic effects of any prior treatment have resolved to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 1 or less
TREATMENT WITH SJCAR19: Has recovered from all National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade III-IV, non-hematologic acute toxicities from prior therapy
Persisting toxicity related to prior therapy that has not reduced to grade 1 (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI CTCAE] version 5.0); however, alopecia and sensory neuropathy grade =< 2 is acceptable.
Patients with persistent toxicities (>= Common Terminology Criteria for Adverse Events [CTCAE] grade 2) with the exception of alopecia, caused by previous cancer therapy
Patients who have received palliative radiotherapy within 2 weeks of study entry and have not recovered to grade 1 or baseline from associated toxicities. Note: Patients may receive palliative radiation once enrolled on study. The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies, including surgery, except alopecia and other non-clinically significant adverse events (AEs).
History of, or known, central nervous system (CNS) disease involvement, or prior history of National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Grade ? 3 drug-related CNS toxicity
Unstable symptomatic ischemic heart disease, ongoing arrhythmias of grade > 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 5.0), New York Association class III or IV heart failure
Subject has not fully recovered to baseline or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) ? Grade 1 from toxicity due to all prior therapies, except alopecia and other non-clinically significant AEs.
Diarrhea > grade 1 based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) in the absence of antidiarrheals
Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\r\n* Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician.\r\n* Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the study physician.
Resolution of all toxic side effects of prior chemotherapy, radiotherapy, or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade ? 1
Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to start of study treatment. Any previous venous thromboembolism > National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 3.
Known severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version [v] 5.0), any history of anaphylaxis or history of uncontrolled asthma
Persistent prior therapy-related toxicities greater than grade 2 according to Common Toxicity Criteria for Adverse Events (CTCAE) v4.03, except for peripheral neuropathy, alopecia, or vitiligo prior to enrollment.
Subjects must have progressed despite at least 1 prior line of treatment for metastatic and/or unresectable urothelial cancer. However, cisplatin-ineligible (defined by a calculated creatinine clearance of >= 40 but < 60 mL/min OR Common Terminology Criteria for Adverse Events [CTCAE] version [v]4 grade >= 2 audiometric hearing loss OR CTCAE v4 grade >= 2 peripheral neuropathy OR ECOG performance status [PS] = 2), chemotherapy-naive subjects are also eligible
Persisting toxicity related to prior therapy (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]. 4.03 grade > 1); however, alopecia, sensory neuropathy grade =< 2, or other grade =< 2 not constituting a safety risk based on investigator's judgement are acceptable
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 3 hemorrhage within 4 weeks of starting the study treatment
Known severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] v4.03), any history of anaphylaxis, or recent (within 5 months) history of uncontrolled asthma.
Resolution of all acute toxic effects of prior chemotherapy, radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 grade 1
Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria: -- Subjects with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the principal investigator.-- Subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the principal investigator.
Known severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03)
Peripheral edema >= grade 2 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Prohibited anti-NSCLC therapies and not having recovered from related AEs to Common Terminology Criteria for Adverse Events (CTCAE) Grade ?1
Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 (with the exception of alopecia grade 2) at the time of starting study treatment
Recovery to baseline or grade =< 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 from toxicities related to any prior treatments, unless adverse events (AEs) are clinically nonsignificant and/or stable on supportive therapy
Has known gastrointestinal bleeding or any other hemorrhage/bleeding event Common Terminology Criteria for Adverse Events (CTCAE) grade > 3 within 6 months of start of study drug
STUDY TREATMENT: Peripheral neuropathy less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1.
Unresolved toxicities from prior anti-tumor therapy (defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1, or to levels dictated in the eligibility criteria) with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible [defined as having been present and stable for > 28 days] which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen
Patients with a known allergy or hypersensitivity to the protocol therapies or any of their components to be used in the arm the patient is to be enrolled on. Known severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma).
Subjects must have recovered to =< grade 1 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 or stabilized from toxicity of prior chemotherapy or biologic therapy administered more than 4 weeks or 5 half-lives earlier, whichever is shorter
Toxicities of prior therapy (except alopecia) should be resolved to =< grade 1 as per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0; patients with long-standing stable grade 2 neuropathy or others (e.g., adrenal insufficiency or hypothyroidism on stable doses of replacement therapy) may be allowed after discussion with the study principal investigator (PI)
Presence of ? Common Terminology Criteria for Adverse Events (CTCAE) grade 2 toxicity due to prior cancer therapy (except alopecia, peripheral neuropathy which are excluded if ? CTCAE grade 3)
Proteinuria < Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or greater
Known severe (National Cancer Institute [NCI]- Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03 grade 3 or 4) infusion-related allergy or acute hypersensitivity reaction attributed to any monoclonal antibody, any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
Toxicities related to prior anticancer treatment (except alopecia) that have not resolved to =< grade 1 according to common terminology criteria for adverse events (CTCAE version [V]4.0) before registration or prior to start of therapy
Not recovered from adverse events (AE)s or toxicities due to previous treatments to a grade 1 or less specified in National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 excepting, albumin (< 2.5 g/dL), AST and ALT in patients with liver metastases (> 5 x ULN) alkaline phosphatase (ALP) in patients with bone metastases (> 5 x ULN) and alopecia
Patients with peripheral neuropathy > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Unresolved toxicity higher than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 attributed to any prior therapy or procedure, excluding alopecia
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03 grade ? 3)
Ineligible to receive cisplatin by meeting one or more of the following criteria\r\n* Creatinine clearance of < 50 mL/min\r\n* Hearing loss of 25 dB at two contiguous frequencies\r\n* Common Terminology Criteria for Adverse Events (CTCAE) version 4 (v4) grade 2 or higher peripheral neuropathy\r\n* New York Heart Association class III or IV heart failure\r\n* ECOG performance status 2 or higher
Serum sodium, potassium, and calcium levels equivalent to grade 1 adverse event (AE) values as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Subjects with >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 toxicity (except alopecia) due to prior cancer therapy.
Resolved acute effects of any prior therapy to baseline severity or grade =< 2 Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03 except for adverse events (AEs) not constituting a safety risk by investigator judgment
Absolute neutrophil count ? 1,500 cells/uL equivalent to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03) grade 1
Platelets ? 100,000/uL equivalent to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03) grade 1
Have resolution of Adverse Events (AEs), with the exception of alopecia, and of all clinically significant toxic effects of prior locoregional therapy, surgery or radiotherapy to ?Grade 1, by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0.
Patients may have received any number of prior lines of therapy. All prior systemic anti-cancer treatment-related toxicities must be less than or equal to grade 1 according to the Common Terminology Criteria for Adverse Events version 4 (CTCAE version 4.0; National Cancer Institute [NCI], 2009) at the time of enrollment. This does not include alopecia and grade 1 or less peripheral neuropathy.
Persisting toxicity related to prior therapy (Common Terminology Criteria for Adverse Events [CTCAE] > grade 1); however, alopecia, sensory neuropathy =< grade 2, or other =< grade 2 not constituting a safety risk based on the investigator’s judgment are acceptable
All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) or baseline prior to administration of first dose of study drug; subjects with toxicities attributed to prior anti-cancer therapy that are not expected to resolve and result in long-lasting sequelae, such as chronic neuropathy after platinum based therapy, are permitted to enroll
Persistent toxicities (>= common terminology criteria for adverse events grade 2) with the exception of alopecia, caused by previous cancer therapy.
Any unresolved toxicity NCI Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\r\n* Subjects with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the principal investigator\r\n* Subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the principal investigator
Subjects with toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue that have not resolved to grade 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events\r\n[CTCAE] version 4.03) or baseline before administration of study drug.
Subject has recovered from clinically significant acute treatment related toxicities from all prior therapies. Recovery is defined as a toxicity Grade ? 2 (common terminology criteria for adverse events [CTCAE] v. 4.03).
Unresolved diarrhea >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or a medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease)
Neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Active uncontrolled infection National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Grade greater than or equal to 3).
Resolution of all acute toxic effects of prior chemotherapy, immunotherapy, radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1
Subject has recovered to grade =< 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 (NCI-CTCAE v 4.03) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies, with the exception of alopecia. The exceptions for such effects are allowed lab values of =< grade 2 specified elsewhere in these inclusion criteria.
Any unresolved toxicity Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anti-cancer therapy; exceptions include hearing loss, peripheral neuropathy, and alopecia
The subject has recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v.)4.03 from toxicities related to any prior treatments, unless adverse event (AE)(s) are clinically nonsignificant and/or stable on supportive therapy
Clinically significant peripheral neuropathy at the time of enrollment (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v4.0) as grade 2 or greater neurosensory or neuromotor toxicity)
Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v.)4.03 from toxicities related to any prior treatments, unless adverse events (AE[s]) are clinically non-significant and/or stable on supportive therapy
Any unresolved toxicity NCI Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
Any unresolved toxicity (Common Terminology Criteria for Adverse Events [CTCAE] grade >= 2) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy).
Diarrhea > grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 grading, in the absence of antidiarrheals
Absence of clinically significant bradycardia, or other uncontrolled cardiac arrhythmia defined as grade 3 or 4 according to National Cancer Institute (NCI) Common Terminology
Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03 grade ? 3)
Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria; subjects with grade ? 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician; subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the study physician
No dehydration of National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) grade >= 1
Grade >= 3 peripheral neuropathy according to (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]) version 4.0
Haematological and liver function test results ? grade 2 toxicity (according to US National Cancer Institute's Common Terminology) Criteria for Adverse Events v4.03 [CTCAE
Resolution of all acute adverse events resulting from prior cancer therapies to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ? 1 or baseline (except alopecia or neuropathy)
Persisting toxicity related to prior therapy (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v.] 4.03 grade > 1); however, alopecia, sensory neuropathy grade =< 2, grade 2 anemia, or other grade =< 2 not constituting a safety risk based on investigator’s judgment are acceptable
STUDY TREATMENT: All toxicities attributed to prior anti-cancer therapy other than nephropathy, neuropathy, hearing loss, alopecia and fatigue must have resolved to grade 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4) or baseline before administration of study drug; subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum based therapy, are permitted to enroll
Peripheral neuropathy of grade >= per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, at the time of or within 3 weeks prior to the first study therapy
Active known clinically serious infections (> grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 4.03)
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 4.03) =< grade 1 at the time of screening (except alopecia)
Known severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
Any unresolved chronic toxicity >= grade 2 from previous anticancer therapy (except alopecia and anemia), according to Common Terminology Criteria for Adverse Events version (v)4.0 (CTCAE)
Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 from toxicities related to any prior treatments, unless adverse events (AE[s]) are clinically non-significant and/or stable on supportive therapy
Prior treatment toxicities have not resolved to =< grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (except for alopecia and neuropathy)
Any immunotherapy-related adverse events Common Terminology Criteria for Adverse Events (CTCAE) > grade 1 at the time of registration
Any unresolved toxicity (? Common Terminology Criteria for Adverse Events [CTCAE] grade 2) from previous anti-cancer therapy. NOTE: Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
Must have completed prior chemotherapy, immunotherapy, or radiation therapy at least 14 days prior to start of treatment and all toxicity must be resolved to Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 1 (with the exception of CTCAE v4.0 grade 2 neuropathy) prior to start of treatment
All toxicities attributed to prior anti-cancer therapy other than neuropathy, alopecia and fatigue must have resolved to grade 1 (National Cancer institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4) or baseline before administration of study drug; subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum based therapy, are permitted to enroll; neuropathy must have resolved to grade 2 (NCI CTCAE version 4)
The subjects who have not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from related toxicity to all prior therapies will be excluded; patients with non-serious adverse events such as alopecia, fatigue, weakness, loss of appetite and nausea that are non-significant will not be excluded
Previous treatment-associated clinically significant toxicities resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade =< 1 (except alopecia) or baseline
Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn’s disease, malabsorption, or grade >= 2 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v.4.0] diarrhea of any etiology at baseline)
Patients must have resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade =< 1 or to the baseline laboratory values as defined in the inclusion criteria
Presence of toxicities attributed to prior therapy other than alopecia that have not resolved to grade 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4) or baseline before administration of study drug
Resolution of all acute toxic effects of prior chemotherapy, immunotherapy, radiotherapy or surgical procedures to =< grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03); exception to this criterion: patients with any grade of alopecia are allowed to enter the treatment
The patient has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from adverse event at time of enrollment due to cancer therapy administered more than 28 days prior to enrollment
Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2) from previous anti-cancer therapy
No Common Terminology Criteria for Adverse Events (CTCAE) v4 grade > 2 neuropathy
Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03 grade >= 3)
Known severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
Have any unresolved chronic toxicity with Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade >= 2, from previous anticancer therapy, except for alopecia
Presence of any toxicities attributed to prior anti-cancer therapy, other than alopecia, that have not resolved to grade 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4) or baseline before administration of study drug
Unresolved toxicity ? Common Terminology Criteria for Adverse Events (CTCAE) grade 2 from previous anti-cancer therapy except alopecia (if applicable) unless agreed that the patient can be entered after discussion with the medical monitor
Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade =< 1 (Exception to this criterion: patients with any grade of alopecia are allowed to enter the study)
Persisting toxicity related to prior therapy (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.03 [v4.03] grade > 1); however alopecia, sensory neuropathy grade =< 2, or other grade =< 2 adverse events (AEs) not constituting a safety risk based on investigator's judgment are acceptable
Known severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia
Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version [v]4), grade =< 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia
Any hemorrhage or bleeding event >= National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 3 within 4 weeks prior to start of study medication
Not recovered to a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03 grade =< 1 from adverse events (AEs) (except alopecia and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other medications that were administered prior to study drug
Presence of peripheral neuropathy >= grade 3 based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v 4.0)
Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 1) from previous anti-cancer therapy, excluding alopecia. Subjects with irreversible toxicity greater than grade 1 that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy).
Any previous venous thromboembolism > National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 3
With the exception of alopecia, any unresolved toxicities from prior therapy ? Common Terminology Criteria for Adverse Events (CTCAE) grade 2
The subject has not recovered to baseline or Common Terminology Criteria For Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
Patients who have not recovered from adverse events attributed to prior anti-cancer therapy (i.e. have residual toxicities > grade 1, except for alopecia, neuropathy, lymphocytopenia and other non-clinically significant adverse events)
Presence of any toxicities attributed to prior anti-cancer therapy that are not resolved to grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0) or baseline before administration of study drug
Persistent toxicities (>= Common Terminology Criteria for Adverse Events [CTCAE] grade 2), with the exception of alopecia, caused by previous cancer therapy
Has gastrointestinal bleeding or any other hemorrhage/bleeding event Common Terminology Criteria for Adverse Events (CTCAE) grade > 3 within 6 months of registration
Residual acute toxic effects of prior anti-cancer therapy that have not resolved to Common Terminology Criteria for Adverse Events version 4 (CTCAE v.4) grade =< 1 (except alopecia or other grade II or above toxicities not considered a safety risk for the patient at investigator's discretion)
Toxicities of prior therapy (except alopecia) should be resolved to =< grade 1 as per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0; patients with long-standing stable grade 2 neuropathy may be considered after discussion with the study principal investigator (PI)
Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 2 from previous anti-cancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\r\n* Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis and may be included after consultation with the study physician\r\n* Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with their assigned investigational product (IP) (e.g., hearing loss) may be included after consultation with the study physician
Unresolved toxicities from prior anticancer therapy, defined as having resolved to Common Terminology Criteria for Adverse Events (CTCAE, version 4.03), grade 0 or 1, with the exception of alopecia
Diarrhea > grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading, in the absence of antidiarrheals
Fully recovered from acute toxicities (except alopecia) of all prior therapies to Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1
Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2) from previous anti-cancer therapy; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
Persisting toxicity related to prior therapy that has not reduced to grade 1 (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI CTCAE] version 4.03); however, alopecia and sensory neuropathy grade =< 2 is acceptable
Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version [v]4.03), grade =< 2, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia
Presence of ? CTCAE grade 2 toxicity (except alopecia of any grade) due to prior cancer therapy, according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4.03)
Has not recovered from adverse events due to prior therapies, i.e. monoclonal antibody, chemotherapy, targeted small molecule therapy, radiation therapy, or surgery.\r\n* Note: Subjects with grade 2 neuropathy, alopecia and general disorders and administration site conditions (per Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) are an exception to this criterion and may qualify for the study.
Unresolved toxicity from previous anticancer treatments, including investigational products (subjects must have recovered all unacceptable toxicity to ? Grade 1 Common Terminology Criteria for Adverse Events [CTCAE] toxicity). This does not extend to symptoms or findings that are attributable to the underlying disease
Patients with a known allergy or hypersensitivity to avelumab, 5-azacytidine, or any of their components; known severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
Any unresolved toxicity (Common Terminology Criteria for Adverse Events [CTCAE] grade >= 2) from previous anti-cancer therapy; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
Lack of recovery of prior adverse events to grade =< 1 severity (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version [v] 4.03) (except alopecia) due to therapy administered prior to the initiation of study drug dosing; stable persistent grade 2 peripheral neuropathy may be allowed as determined on a case-by-case basis at the discretion of the investigator
Symptomatic peripheral neuropathy >= grade 2 by National Cancer Institute (NCI) Common Terminology Criteria (NCI-CTC) version 4
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) less than or equal to grade 2 (except alopecia) at the time of screening however clinically relevant adverse events (AEs) that will impact on the adverse drug event (ADE) of the study drugs or safety of the subject must have resolved to grade 1 or better
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or grade >= 2 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v.4.0] diarrhea of any etiology at baseline)
All prior treatment-related toxicities must be National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.0 <=Grade 1 at the time of enrollment (except for alopecia).
Previous treatment-associated toxicities resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade =< 2 (except alopecia)
Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 3-4 neuropathy
Any unresolved toxicity >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 from previous anti-cancer therapy, except for alopecia and neurotoxicity
Proteinuria Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or greater
Any unresolved toxicity (Common Terminology Criteria for Adverse Events [CTCAE] grade 2 or above) from previous anti-cancer therapy; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4), grade =< 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia
Presence of >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 toxicity (except alopecia or peripheral neuropathy) due to prior cancer therapy
Unresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute’s (NCI’s) Common Terminology Criteria for Adverse Events (CTCAE) (NCI CTCAE version [v]4.03) grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria with the exception of alopecia; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by nivolumab may be included (eg, hearing loss) after consultation with the principal investigator
Recovery from toxicity from any prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.03) to grade 1 or better (except for =< grade 2 neuropathy, alopecia, xerostomia, dysphagia, or mucositis)
Patients with ongoing toxicities > grade 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 (excluding alopecia) due to prior anti-cancer therapy
Patients who have not recovered from adverse events of prior therapy to =< National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 1
Patients who received prior medical therapy for a NF1 related tumor must have recovered from the acute toxic effects of all prior therapy to =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 before entering this study
Any unresolved Common Terminology Criteria for Adverse Events (CTCAE) grade >2 toxicity from previous anti-cancer therapy; patients with irreversible toxicity that is not reasonably expected to be exacerbated by study therapy (eg, hearing loss) may be enrolled after discussion with the principal investigators
Peripheral neuropathy ? grade 2 (Common Terminology Criteria for Adverse Events CTCAE)
Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2) from previous anti-cancer therapy; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
Peripheral sensory neuropathy or peripheral motor neuropathy >= grade 2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0
Unresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (eg, hearing loss) after consultation with the study chair
Unresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03 grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by durvalumab and tremelimumab may be included (e.g. hearing loss) after consultation with the principal investigator
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
All prior treatment-related toxicities must be National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4 =< Grade 1 (except alopecia [permissible at any Grade] and peripheral neuropathy [which must be =< Grade 2]) at the time of treatment allocation.
Ongoing >= grade 3 cardiac, pulmonary, renal, gastrointestinal or hepatic toxicities according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 toxicity criteria
PHASE I AND II SCLC AND UROTHELIAL CARCINOMA EXPANSION COHORT: Persistent toxicities (>= Common Terminology Criteria for Adverse Events [CTCAE] grade 2) with the exception of alopecia and neuropathy, caused by previous cancer therapy
Pre-existing peripheral neuropathy > grade 1 (using Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.3 criteria)
Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy
Bilirubin =< 1.5 times upper limit of normal (Common Terminology Criteria for Adverse Events [CTCAE] grade 1 baseline)
Patients must have recovered from all clinically relevant toxicities related to prior anticancer therapies to =< grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03); exception to this criterion: patients with any grade of alopecia are allowed to enter the treatment
Neuropathy (sensory and motor) =< Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria: a) patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician; b) patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the study physician
Must have =< grade 1 pre-existing peripheral neuropathy (as per Common Terminology Criteria for Adverse Events [CTCAE])
Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4.03), grade 0 or 1, or to the levels dictated in the inclusion/exclusion criteria, with the exception of alopecia
Pre-existing motor or sensory neurotoxicity greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Any active grade 3 or higher (per the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.03) viral, bacterial, or fungal) infection within two weeks prior to the first dose of study treatment
Peripheral neuropathy grade 0 or 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Preexisting grade 3 or 4 nervous system disorder as per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Active known clinically serious infections (> grade 2 National Cancer Institute [NCI]- Common Terminology Criteria for Adverse Events [CTCAE] version 4.03)
Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2) from previous anti-cancer therapy; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
Failure to fully recover from acute, reversible effects defined as =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0 of prior chemotherapy regardless of interval since last treatment except alopecia and neuropathy
Grade 3 or worse peripheral neuropathy as defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.1
Prior treatment toxicities not resolved to =< grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 except alopecia and neuropathy
Patients must have recovered from toxicity related to prior therapy to at least grade 1 (defined by Common Terminology Criteria for Adverse Events version 4.0 [CTCAE 4.0]) or baseline level; chronic stable grade 2 peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis by the principal investigator
Must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from the acute effects of any prior surgery, chemotherapy or radiation therapy; chronic residual toxicity (i.e. peripheral neuropathy) is permitted
Persistence of any clinically relevant (Common Terminology Criteria for Adverse Events [CTCAE] grade 2 or above) toxicities from previous AML therapy
All AEs of any prior chemotherapy, surgery, or radiotherapy not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version [v.]4.0) grade =< 2
Full recovery from the acute effects of prior cancer treatments, defined as effects having resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade 0 or 1 with the exception of alopecia and certain laboratory values as listed above; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by MEDI4736 and tremelimumab may be included (eg, hearing loss, neuropathy) upon approval of the principal investigator (PI)
All acute toxic effects of any prior treatment have resolved to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) grade 1 or less at the time of signing the informed consent form (ICF) except for alopecia
Patients who have not had resolution of clinically significant toxic effects of prior anticancer therapy to =< grade 1 as per by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v. 4.0)
Must have recovered from adverse effects of any prior surgery, radiotherapy or other antineoplastic therapy; Common Terminology Criteria for Adverse Events (CTCAE) adverse events less than or equal to grade 1 are acceptable; CTCAE adverse events grade 2 or greater may be acceptable as determined by the principal investigator
All previous therapies for cancer, including radiotherapy, major surgery and investigational therapies must be discontinued for >= 14 days (>= 28 days for mitomycin C or nitrosoureas) before cycle 1 day 1 (C1D1), and all acute effects of any prior therapy must have resolved to baseline severity or grade =< 1 Common Terminology Criteria for Adverse Events (CTCAE version [v] 4.03), except alopecia or parameters defined in this eligibility list
Unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 2 due to prior therapies
Symptomatic nodal disease, i.e. scrotal, penile or leg edema (>= Common Terminology Criteria for Adverse Events [CTCAE] grade 3)
Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade < 1 (exception to this criterion: patients with any degree of alopecia are allowed to enter the study)
Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2) from previous anti-cancer therapy
CAPMATINIB INCLUSION CRITERIA: Resolution of all acute toxic effects (excluding alopecia) of prior radiotherapy, chemotherapy or surgical procedures to Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade =< 1
Known severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.0), any history of anaphylaxis, or uncontrolled asthma
PHASE I: Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade 2) caused by prior cancer therapy, excluding alopecia
PHASE II: Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade 2) caused by prior cancer therapy, excluding alopecia
Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\r\n* Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the treating physician and/or PI\r\n* Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the treating physician and/or PI
Concurrent disease or condition that would interfere with study participation or safety, such as any of the following:\r\n* Active, clinically significant infection either grade > 2 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 or requiring the use of parenteral anti-microbial agents within 14 days before day 1 of study drug\r\n* Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders\r\n* Non-healing wound, ulcer, or bone fracture
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (version 4.0) grade 3 or higher toxicities due to any prior therapy (e.g. radiotherapy) (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication
Patients eligible or ineligible for cisplatin-based chemotherapy. Cisplatin ineligibility is defined as meeting 1 of the following criteria: • Creatinine clearance (calculated or measured) <60 mL/min calculated by Cockcroft-Gault equation (using actual body weight) or by measured 24-hour urine collection for determination • Common Terminology Criteria for Adverse Events (CTCAE) Grade ?2 audiometric hearing loss • CTCAE Grade ?2 peripheral neuropathy • New York Heart Association ?Class III heart failure.
Have NO continuing acute toxic effects (except alopecia) of any prior chemotherapy, radiotherapy or surgical procedures; all such effects must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, version 4.03) grade =< 1; surgery (except minor procedures such as biopsies, IV line placement, etc.) must have occurred at least 28 days prior to study enrollment
Patients must have recovered from all toxicities related to any prior anticancer therapies to =< grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03), provided that any concomitant medication is given prior to initiation of treatment with ceritinib; exception to this criterion: patients with any grade of alopecia are allowed to enter the treatment
Resolution of acute toxic effects of prior therapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade =< 1 (except alopecia)
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 from toxicities related to any prior treatment, unless adverse events are clinically non-significant and/or stable on supportive therapy
Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 grade ?1.
Subjects being enrolled to receive paclitaxel plus carboplatin treatment must have neuropathic function (sensory and motor less than or equal to Grade 2 according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.03 (2010)
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events version 5.04 (CTCAE v5.04) grade =< 1 (except alopecia) at the time of enrollment
Peripheral neuropathy =< Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Any unresolved chronic toxicity greater than Common Terminology Criteria for Adverse Event (CTCAE) grade 2 or greater from previous anti-cancer therapy (this criterion does not apply to alopecia)
Neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (v4.0) grade 1 acceptable
Subject has unresolved toxicities from prior anti-cancer therapy, defined as any Common Terminology Criteria for Adverse Events (National Cancer Institute [NCI] CTCAE version [v] 4.0) grade 2 or higher clinically significant toxicity (excluding alopecia)
Subject has proteinuria defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v 4.0) grade > 1 at baseline as measured by a urine dipstick (2+ or greater) and confirmed by a 24 hour urine collection (>= 1 g/24 hrs); subjects may be re-screened if proteinuria is shown to be controlled with or without intervention
Pulmonary hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events (CTCAE) grade 2 within 4 weeks of first dose of study drug
Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE); patients with long-standing stable grade 2 neuropathy may be considered after discussion with the overall principal investigator (PI), but may not receive carboplatin and paclitaxel as the reference regimen, if randomized to that arm
Absolute neutrophil count (ANC) greater than or equal to 1,500/uL, equivalent to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4 grade 1
Other organ toxicity due to prior anticancer therapy (investigational agent, chemotherapy, or radiation therapy) except alopecia, and ototoxicity due to cisplatin not already covered in the inclusion/exclusion criteria, which has not recovered to Grade less than 2 per Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Resolution of all acute adverse events resulting from prior cancer therapies to National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) grade =< 1 or baseline (except alopecia or neuropathy)
Unstable symptomatic ischemic heart disease, ongoing arrhythmias of grade > 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.03), New York Association class III or IV heart failure
Has not recovered from adverse events due to prior therapies, i.e. monoclonal antibody, chemotherapy, targeted small molecule therapy, radiation therapy, or surgery; (Note: subjects with grade 2 neuropathy, alopecia and general disorders and administration site conditions [per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0] are an exception to this criterion and may qualify for the study)
Concurrent disease or condition that would interfere with study participation or safety, such as any of the following:\r\n* Active, clinically significant infection either grade > 2 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 or requiring the use of parenteral anti-microbial agents within 7 days before day 1 of study drug\r\n* Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Patients must have been treated with fulvestrant for at least 56 days as their most current anti-cancer treatment, and they must be tolerating fulvestrant with at most grade I toxicity by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Pre-existing peripheral neuropathy that is >= grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 criteria
Experiencing any clinically significant adverse events above grade 1 (according to Common Terminology Criteria for Adverse Events [CTCAE] 4.0) due to agents administered more than 30 days earlier; however, patients with grade 2 alopecia will be considered eligible
All acute toxic effects of any prior treatment have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 4.0 grade 1 or less at the time of signing the informed consent form (ICF)
Any other serious illness or medical condition, such as but not limited to:\r\n* Any infection >= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 grade 2\r\n* Cardiac failure New York Heart Association (NYHA) III or IV\r\n* Crohn’s disease or ulcerative colitis\r\n* Known bone marrow dysplasia
Recovery from non-hematologic toxicities of salvage cytoreductive chemotherapy to =< grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version 4 [v4])
Persistent clinically significant toxicity from prior chemotherapy that is Grade 2 or higher by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (v4.03).
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Patients must have recovered from all toxicities related to prior anticancer therapies to =< grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03), provided that any concomitant medication is given prior to initiation of treatment with ceritinib; exception to this criterion: patients with any grade of alopecia are allowed to enter the treatment
Patients who have not recovered (=< Common Terminology Criteria for Adverse Events [CTCAE] grade 1) from adverse events (with the exception of alopecia) due to agents administered more than 4 weeks earlier
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) =< grade 1 (except alopecia) at the time of enrollment
Hepatic toxicity grade 2 (using Common Terminology Criteria for Adverse Events [CTCAE] version 4 standard definitions)
Any unresolved toxicity Common Terminology Criteria for Adverse Events (CTCAE) > grade 2 from previous anti-cancer therapy
Peripheral neuropathy of National Cancer Institute (NCI)- Common Terminology Criteria (CTC) grade >= 2
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.0) grade =< 1 (except alopecia); grade 2 prior treatment related toxicities may be allowed after discussion with the principal investigator
Chemotherapy, radiation, or biological cancer therapy within 4 weeks prior to the first dose of study drug, or who has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the adverse events due to cancer therapeutics administered more than 4 weeks earlier
The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan; the subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< Grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
Prior non-hematologic treatment toxicities must be resolved to =< grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, with the exception of the following grade 2 toxicities: alopecia; dry skin; spleen disorders, hearing impairment; tinnitus; hypothyroidism; hyperthyroidism; endocrine disorders; blurred vision; cataracts; constipation; gastroesophageal reflux; fatigue; abnormal coagulation tests international normalized ratio (INR) and/or activated partial thromboplastin time (aPTT); weight gain or weight loss; anorexia; glucose intolerance; hypoalbuminemia; hypokalemia; muscle weakness; dysgeusia; paresthesias; peripheral motor and/or sensory neuropathy; hot flashes; hypertension
Baseline hearing deficit (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0 grade 2 or higher)
All prior anti-cancer treatment-related toxicities must be less than or equal to grade 1 according to the Common Terminology Criteria for Adverse Events version 5 (CTCAE version 5.0; National Cancer Institute [NCI], 2017) at the time of enrollment; a notable exception are endocrinopathies caused by immune checkpoint inhibitors that are appropriately treated with medical management (e.g. hormone replacement therapy, anti-diabetic agents)
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events version 4 (CTCAE v 4) grade =< 1 (except alopecia) at the time of enrollment; this requirement to return to =< grade 1 does not apply to immune checkpoint inhibitor related endocrinopathies (e.g. thyroiditis, hypophysitis, etc.) that necessitate hormone replacement therapy including, but not limited to levothyroxine, cortisol, and testosterone; CTCAE v5.0 will be utilized beginning April 1, 2018
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs) (e.g. albumin)
Peripheral neuropathy of grade 2 or greater severity as defined by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0; patients with grade 2 or higher (NCI-Common Toxicity Criteria [CTC]) neuropathy
Patients with gastrointestinal bleeding or any other hemorrhage/bleeding event (Common Terminology Criteria for Adverse Events [CTCAE] version [v.]4) grade 3 or greater within 30 days prior to registration will be ineligible
The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (v4.0) grade =< 1 from adverse events (AEs) (except alopecia, anemia, and lymphopenia) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study
Resolution of all chemotherapy or radiation-related toxicities =< Common Terminology Criteria for Adverse Events (CTCAE) grade 1 severity, except for alopecia and hematologic toxicity; patients taking temozolomide can start study treatment 23 days from the last temozolomide dose; for all other chemotherapy drugs, study treatment can start as long as adverse events related to their treatment is =< to grade 1
Patients with unresolved diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Patients must have recovered from all acute toxicities (defined as Common Terminology Criteria for Adverse Events [CTCAE] 4.0 =< grade 1) associated with any prior therapy
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Resolution of any effects of prior therapy (except alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade =< 1 and to baseline laboratory values as defined below
Patients with =< grade 1 peripheral neuropathy are eligible for this trial using the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0, regardless of use of therapy for neuropathy including gabapentin
History of infection meeting any of the following criteria:\r\n* Any infection that would be scored as grade 4 by Common Terminology Criteria for Adverse Events (CTCAE) that occurred within six weeks of study screening\r\n* Any infection that would be scored as grade 3 by CTCAE that occurred within two weeks of study screening\r\n* History of fungal and mycobacterial infections, unless at least six weeks has passed since the completion of induction antimicrobial therapy; patients may be receiving consolidation therapy for infections of these types
Clinically significant peripheral neuropathy at the time of randomization (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v4.0] as grade 2 or greater neurosensory or neuromotor toxicity)
Recovery from non-hematologic toxicities of salvage cytoreductive chemotherapy to =< grade 2 (Common Terminology Criteria for Adverse Events version 4 [CTCAE v4])
Pulmonary hemorrhage/bleeding event >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 within 4 weeks of first dose of study drug
Participants with active diarrhea >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 despite medical management
Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2 platinum-therapy related neuropathy
Not recovered from side effects of prior therapy to ? Grade 1 (according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 4.03). Certain side effects that are unlikely to develop into serious or life-threatening events (e.g. alopecia) are allowed at > Grade 1.
Diarrhea > grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading, or currently taking antidiarrheals
Potassium, magnesium, corrected calcium or phosphate abnormality of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) > grade 1
Presence of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) ? grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if ? NCI CTCAE grade 3) due to prior cancer therapy
Unresolved toxicity > Common Terminology Criteria for Adverse Events (CTCAE) grade 2 from previous anti-cancer therapy, except for alopecia
Patients with grade 3 toxicities or less using the Common Toxicity Criteria (version 3.0) developed by the National Cancer Institute of the United States of America (USA) (Common Terminology Criteria for Adverse Events version 3.0) related to cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam
Unresolved toxicity higher than National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/procedure excluding alopecia, anemia and/or hypothyroidism
Any unresolved toxicity of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2, including electrolyte abnormalities, from previous anticancer therapy, with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\r\n* Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician\r\n* Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the study physician
Presence of CTCAE (Common Terminology Criteria for Adverse Events) grade ? 2 peripheral neuropathy.
Known severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version [v]4.0), any history of anaphylaxis or uncontrolled asthma
Peripheral neuropathy of Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade >= 2
Patients who have been treated with most recent radiotherapy, hormonal therapy, immunotherapy, chemotherapy or investigational drugs within ?21 days or 5 half-lives (whichever is shorter) from enrolment (screening), and/or who have any unresolved NCI Common Terminology Criteria of Adverse Events (CTCAE) v4.03 > Grade 1 treatment-related side effect (with the exception of alopecia).
Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade < or equal to 2 from toxicities related to prior therapy within 4 weeks prior to start of any therapy
Inability to swallow oral medications or a recent acute gastrointestinal disorder with diarrhea e.g., Cohn's disease, malabsorption, or Common Terminology Criteria for Adverse Event (CTCAE) Grade > 2 diarrhea of any etiology at baseline
Presence of neuropathy > Grade 2 (National Cancer Institute Common Toxicity Criteria [NCI CTC]; v4.0)
Symptomatic peripheral neuropathy >= grade 2 by National Cancer Institute (NCI) Common Terminology Criteria (NCI-CTC) version 4
All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.03, must be <=Grade 1 at the time of enrolment except for alopecia and Grade 2 peripheral neuropathy.
Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade ?2 audiometric hearing loss
Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0. In CTCAE version 4.0 grade 2 sensory neuropathy is defined as “moderate symptoms; limiting instrumental activities of daily living (ADLs).
All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE], Version 4.03, 2010) must be <= Grade 1 at the time of enrollment, except for alopecia and Grade 2 neuropathy.
Resolution of all acute toxic effects of prior therapy or surgical procedures to Common Terminology Criteria for Adverse Events (CTCAE) grade =< 1 (except alopecia)
Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia
Resolution of any clinically significant toxic effects of prior therapy to grade 0 or 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03 (exception of alopecia and grade 2 peripheral neuropathy).
Active, ongoing toxicity (Common Terminology Criteria for Adverse Events [CTCAE] grade 2 or higher) from prior therapy
All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version [v] 5.0) or baseline before administration of study treatment. Participants with toxicities attributed to prior anti-cancer therapy that are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum-based therapy, are permitted to enroll
Any unresolved toxicity (non-immune mediated) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 from previous anticancer therapy with the exception of alopecia\r\n* However, patients with irreversible toxicity not reasonably expected to be exacerbated by the treatment with durvalumab + trabectedin may be included only after consultation with the study physician
RENAL COHORT: Recovery to baseline or ? grade 1 Common Terminology Criteria for Adverse Events (CTCAE) v.4.0 from toxicities related to any prior treatments, unless adverse events (AEs) are clinically nonsignificant and/or stable on supportive therapy
Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v.)4.0 from toxicities related to any prior treatments, unless AE(s) are clinically non-significant and/or stable on supportive therapy
Full recovery from the acute effects of prior treatments, defined as effects having resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03 grade 0 or 1 with the exception of alopecia and certain laboratory values as outlined below; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by durvalumab and tremelimumab may be included (e.g., hearing loss, neuropathy) upon approval of the principal investigator (PI)
Patient who has had chemotherapy, radiation therapy, or biological cancer therapy within four weeks prior to the first dose of study drug, or who has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from the adverse events (AEs) due to cancer therapeutics administered more than four weeks earlier
Fully recovered from acute toxicities (except alopecia) of all prior therapies to Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1
Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4.03), grade 2 or less, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia
Persistent toxicities (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia.
Any unresolved toxicity Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or more from previous anti-cancer therapy, except alopecia, hearing loss, peripheral neuropathy or non-clinically significant laboratory abnormalities
Patient has not recovered to CTCAE Common Terminology Criteria for Adverse Events (CTCAE) (version 4.03) grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy.
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) =< grade 1 (except alopecia)
Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 1) from previous anti-cancer therapy with the exception of alopecia; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripheral neuropathy)
Pre-existing peripheral neuropathy that is >= grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) v4 criteria
Sensory peripheral neuropathy > Common Terminology Criteria for Adverse Events (CTCAE) grade 1
All acute toxic effects of any prior treatment have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v)4.0 grade 1 or less at the time of signing the informed consent form (ICF); exceptions to this include alopecia
History of Common Terminology Criteria for Adverse Events (CTCAE) grade >= 3 hypersensitivity to paclitaxel or Cremophor EL
Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [V] 4.0) resulting from prior therapy must be =< grade 2
Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v 4.0) grade 2 or higher from previous anti-cancer therapy, except alopecia
Any acute toxicities due to prior chemotherapy and / or radiotherapy that have not resolved to a Common Terminology Criteria for Adverse Events version 4.0 grade <=1 with the exception of chemotherapy induced alopecia and grade 2 peripheral neuropathy.
Part 1 patients who have not recovered to < Common Terminology Criteria for Adverse Events (CTCAE) grade 2 toxicities related to prior therapy are ineligible
Participants with diarrhea >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from related toxicity to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
Subjects who have not recovered from toxicities from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 0 or 1, or to levels dictated in the eligibility criteria with the exception of alopecia (grade 2 or 3 toxicities from prior antitumor therapy that are considered irreversible [defined as having been present and stable for > 6 months], such as grade 2 chemotherapy-induced peripheral neuropathy, may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and sponsor)
Patients with peripheral neuropathy >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 are ineligible
All toxicities attributed to prior anti-cancer therapy must have been resolved to grade 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4) or baseline before administration of study drug(s) other than:\r\n* Patients with toxicities attributed to prior anti-cancer therapy that either are not expected to resolve and/or result in long-lasting sequelae, such as neuropathy after platinum-based therapy, or are not expected to interfere with treatment on study, such as fatigue, alopecia, or grade 2 hematologic toxicity are eligible
Failure to fully recover from acute, reversible effects defined as =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0 of prior chemotherapy regardless of interval since last treatment
Grade 3-4 electrolyte abnormalities (Common Terminology Criteria for Adverse Events [CTCAE], version [v.] 4):
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =< 1 (except alopecia) at the time of enrollment
Any > grade 1 (according to the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v.]4.03) adverse reaction unresolved from previous treatments or not readily managed and controlled with supportive care; the presence of alopecia of any grade and peripheral neuropathy ? grade 2 without pain is allowed
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Common Terminology Criteria for Adverse Events [CTCAE] grade 1 or baseline, with the exception of alopecia)
Active, clinically serious infections > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Any chemotherapy related toxicities from prior treatment (> grade 2 per Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0)
Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) grade 2 or higher from previous anti-cancer therapy, except alopecia, at the time of randomization
Sensory peripheral neuropathy =< grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] version [v.] 4.0)
Recovered from toxic effects of prior therapy to < Grade 2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) prior to Day 1. Minimum duration required between prior therapy and Day 1 is:
Cholesterol < Common Terminology Criteria for Adverse Events (CTCAE) grade 3
The subject has recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicities related to prior treatment, except alopecia, lymphopenia, other non-clinically significant adverse events (AEs)
Peripheral neuropathy of any etiology > grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0)
Recovery from previous cancer treatment (=< grade 1 by Common Terminology Criteria for Adverse Events [CTCAE] 4.0 criteria) prior to first radiation treatment
Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4), grade =< 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia
Total calcium (corrected for serum albumin) within institutional normal limits, or =< grade 1 according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 if judged clinically not significant by the investigator (bisphosphonate use for malignant hypercalcemia control is not allowed)
No pre-existing neuropathy grade > 1 per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Patients who have not recovered to < Common Terminology Criteria for Adverse Events (CTCAE) grade 2 toxicities related to prior therapy are ineligible
Documented hypercoagulable disorders or vasculopathies:\r\n* International normalized ratio (INR) value more than a grade 1 toxicity by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 criteria (> 1-1.5 x upper limit of normal [ULN]; > 1-1.5 times above baseline if on anticoagulation)\r\n* Activated partial thromboplastin time (APTT) value more than a grade 1 toxicity by CTCAE v 4.0 criteria (> ULN-1.5 x ULN)
Patients with pre-treatment peripheral neuropathy greater than grade 1 per the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 will be excluded
Subjects who have a history or current evidence of bleeding disorder, i.e. any hemorrhage/bleeding event of Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 within 4 weeks before the start of study treatment
Patient has >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety
Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade < 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study)
Patient has not recovered from all toxicities related to prior anticancer therapies to grade 1 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study)
Symptomatic peripheral neuropathy > grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) criteria
Peripheral edema >= grade 2 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Electrolytes =< grade 1 severity according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 or if judged clinically not significant by the investigator
Any valve disease Common Terminology Criteria for Adverse Events (CTCAE) grade
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) (version 4.03) grade 2
The corticosteroids prednisone and dexamethasone may be continued until the day before treatment start if all related adverse events are controlled at CTCAE version 4.03 grade =< 1
All prior treatment- related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) =< grade 1 (except alopecia) at the time of enrollment
Previous intolerance to BCG intravesical therapy suggested by development of systemic BCG infection in the past and/or grade 4 or greater adverse effect by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0
Have recovered from prior drug-related toxicity to grade =< 1 Common Terminology Criteria for Adverse Events version 4 (CTCAE v. 4), within 21 days of initiation of on-study treatment
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) version (v)4 grade =< 1 (except alopecia) at the time of registration; subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae are permitted to enroll
Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) grade 2 or higher from previous anti-cancer therapy, except alopecia; in specific cases, will be allowed with permission from the principal investigator
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) version (v)4 grade =< 1 (except alopecia) at the time of randomization
Common Terminology Criteria for Adverse Events (CTCAE) recovered to baseline or CTCAE =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
Previous chemotherapy (adjuvant and metastatic regimens) and hormonal therapy allowed, but chemotherapy must have been discontinued at least 21 days prior to starting study treatment and hormonal therapy at least 7 days prior to starting study treatment; patients must have recovered from acute Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 grade >= 2 side effects of previous treatments; participants with alopecia G2 (CTCAE v4.0) will be allowed in the study
Toxicities (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2) caused by previous cancer therapy
No evidence of ongoing cardiac dysrhythmia >= grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], version [v]4.0)
Prior systemic or antiangiogenic therapy for HCC (including thalidomide, sorafenib, sunitinib, or bevacizumab); prior systemic therapy for other diagnoses is permitted if greater than 6 months have elapsed since last dose, any prior toxicity has recovered to =< grade 1 by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0, and treatment was not discontinued for toxicity
Patients may have received prior chemotherapy for advanced disease as long as it did not include gemcitabine; if patients received prior adjuvant therapy including gemcitabine, patients must be > 6 months from the last dose of gemcitabine; patients must have recovered from side effects of prior therapy to grade =< 1 as measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0
No evidence of ongoing cardiac dysrhythmia >= grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], v 4.0)
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Active clinically serious infection > Common Toxicity Criteria for Adverse Events (CTCAE version 4.0 [v 4.0]) grade 2
Pre-existing peripheral neuropathy, if present, must be < grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
Absolute neutrophil count (ANC) greater than or equal to 1,500/mm^3, equivalent to Common Toxicity Criteria for Adverse Events version (v)3.0 (CTCAE) grade 1
The participant has resolution to Grade 1 or less by Common Terminology Criteria for Adverse Events Version 4.0, of all clinically significant toxic effects of previous therapy.
Subject has cardiac disorders (Common Terminology Criteria for Adverse Events [CTCAE] version 4.03 Grade 3 or 4).
Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v4.0).
No clinically significant (equivalent to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] grade 3-4) bleeding episodes within the past 3 months
For Cohort B: Has peripheral neuropathy Common Terminology Criteria for Adverse Events ?2 except due to trauma
History of severe (defined as ? grade 3, using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 4.0 [NCI-CTCAE] v4 current active minor version) allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients (10 mM Tris buffered saline) in the investigational agent.
Peripheral neuropathy >= grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] version [v]4)
Patient must have a corrected QT (QTc) interval on electrocardiogram (ECG) =< 0.48 seconds by Bazett’s calculation (=< Common Terminology Criteria for Adverse Events [CTCAE] version [v.]4 grade 2) prior to randomization
PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have received any chemotherapy, biologic agent, or any investigational agent within 14 days prior to registration. Patients must have recovered from any adverse events to Common Terminology Criteria for Adverse Events (CTCAE) grade 0-1 prior to registration
Subject has any peripheral neuropathy ? NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events ) Grade 2 at randomization/enrollment.
Significant chronic gastrointestinal disorder with diarrhea as a major symptom (eg, Crohn's disease, malabsorption, or Grade ?2 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v.4.0] diarrhea of any etiology at baseline)
Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =< 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator’s discretion)
Toxicities from previous cancer therapies must have recovered to grade 1 (defined by Common Terminology Criteria for Adverse Events [CTCAE] 4.0) Chronic stable grade 2 peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis
Not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia, oxaliplatin-related neuropathy, asymptomatic electrolyte abnormalities =< grade 2, and other non-clinically significant adverse events
Ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade >= 2
Patients must not currently have a > grade 1 symptomatic neuropathy-sensory (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.0)
All previous chemotherapy or radiation therapy-related toxicities, except dry mouth, dysphagia, esophagitis, mucositis, alopecia, and irreversible late sequelae of radiation therapy, must have resolved to Grade 0 or 1 per Common Terminology Criteria for Adverse Events (CTCAE v 4.03), and all wounds from prior surgery must have adequately recovered.
Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
Have side effects (except alopecia) of prior treatment resolved to at least Grade 1 according to the National Cancer Institute - Common Terminology Criteria of Adverse Events (NCICTCAE) (Version 4.0)
Bilirubin greater than 1.5 x upper limit of normal (ULN) (Common Terminology Criteria for Adverse Events [CTCAE] v4.0 grade 1)
Neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade < 3 (exception to this criterion: patients with any grade of alopecia or neuropathy are allowed to enter the study)
Any non-hematologic toxicity (excluding alopecia) from prior treatment that has not resolved to Grade less than or equal to (<=) 1 (per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0) at screening
None of the following co-morbid conditions:\r\n* Cataracts of grade 2 or greater as per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0\r\n* Retinopathy of grade 2 or greater as per CTCAE version 4.0\r\n** Note: patients that have cataracts that do not require surgery are eligible\r\n** Note: serious adverse events will be reported on CTEP-Adverse Event Reporting System (AERS) using CTCAE version (v)5.0\r\n* Deep vein thrombosis/pulmonary embolism (DVT/PE) within the past 6 months\r\n** Note: patients that are on anticoagulant therapy for maintenance are eligible as long as the DVT and/or PE occurred > 6 months prior to enrollment, and there is no evidence for active thrombosis (either DVT or PE)
Failure to recover (to Common Terminology Criteria for Adverse Events [CTCAE] Grade 0 or Grade 1) from acute non hematologic toxicity (except all grades alopecia or Grade 2 or lower neuropathy ), due to previous therapy, prior to Screening.
Clinically significant toxicity from prior therapy that has not resolved to Grade <=2 (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], v4.0) prior to Day 1 of Cycle 1
Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4), grade =< 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia
Active Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 3 or higher viral, bacterial, or fungal infection
Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Any peripheral neuropathy ? National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade 2.
CTCAE (Common Terminology Criteria for Adverse Events) Grade ?2 bleeding disorder within 4 weeks before the start of anetumab ravtansine
At least 14 days since the end of prior systemic VEGF-targeted treatment (ie, sunitinib, pazopanib, axitinib, or sorafenib), radiotherapy, or surgical procedure with resolution of all treatment-related toxicity (except alopecia and hypothyroidism) either to Grade 0 or 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 4.03) or to baseline.
All prior therapy related toxicities must have resolved to Grade less than 2 severity per Common Terminology Criteria for Adverse Events (CTCAE version 4.03), except alopecia and infertility.
Unresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria
Patients meeting any of the following consensus criteria for initiating treatment for their CLL:\r\n* Progressive symptomatic splenomegaly and/or lymphadenopathy identified by physical examination\r\n* Anemia ( < 11g/dL) or thrombocytopenia ( < 100,000/uL) due to bone marrow involvement\r\n* Presence of unintentional weight loss > 10% over the preceding 6 months\r\n* National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade >= 3 fatigue\r\n* Fevers > 100.5°F or night sweats for > 2 weeks without evidence of infection
National Cancer Institute (NCI) Common Terminology criteria for Adverse Events (CTCAE) Grade 3 hemorrhage within 28 days before Screening
Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4), grade 0 or 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia
Persistent diarrhea or malabsorption >= National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 2, despite medical management
Diarrhea, grade 1 or greater by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version [v.] 4.0); pancreatic cancer patients with clinical evidence of pancreatic insufficiency must be taking pancreatic enzyme replacement
Has history of gastrointestinal bleeding or any other hemorrhage/bleeding event >= grade 3 (Common Terminology Criteria for Adverse Events [CTCAE], version [v.] 4) within 30 days prior to entry in to the trial
Concurrent disease or condition that would interfere with study participation or safety, such as any of the following: \r\n* Active, clinically significant infection either grade > 2 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 or requiring the use of parenteral anti-microbial agents within 14 days before day 1 of study drug \r\n* Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders \r\n* Non-healing wound, ulcer, or bone fracture
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) version (v)4, grade 2 not controlled with antibiotics
All prior treatment-related toxicities must be National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.0 <=Grade 1 at the time of enrollment (except for alopecia).
Previous chemotherapy, immunotherapy, or radiation therapy must have been completed at least 14 days prior to Step 2 Randomization and all toxicity must be resolved to Common Toxicity Criteria for Adverse Events (CTCAE) version (v) 4.0 grade 1 (with the exception of CTCAE v4.0 grade 2 neuropathy) prior to Step 2 Randomization
Current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0
National cancer institute common terminology criteria for adverse events (NCI CTCAE) (version 4.0) Grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding alopecia)
Has recovered from the toxic effects of prior therapy to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or to their clinical baseline
Presence of peripheral neuropathy ? Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) grade =< 1
Subjects who have not recovered from toxicities as a result of prior anticancer therapy, except alopecia and infertility. Recovery is defined as less than Grade 2 severity per Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0).
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
Prior treatment toxicities must be resolved to =< grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
History of grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4) or greater acute intracranial hemorrhage
Subject has resolution to grade ?1 by NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.03 of all clinically significant toxic effects of prior treatment
Participant has resolution to grade ? 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI-CTCAE v 3.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy which must have resolved to grade ? 2
Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 0 or 1, or to levels dictated in the eligibility criteria with the exception of alopecia (grade 2 or 3 toxicities from prior antitumor therapy that are considered irreversible [defined as having been present and stable for > 6 months], such as ifosfamide-related proteinuria, may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and sponsor)
Ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACE) version 4.0 grade >= 2; however, stable atrial fibrillation controlled medically or with a device (e.g. pacemaker) or prior ablation is allowed
Subject has not recovered from adverse reactions to prior cancer treatment or procedures (surgery, chemotherapy, immunotherapy, radiation therapy) to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or better.
Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicity see below limits for inclusion) or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03, Grade of 0 or 1, except for toxicities not considered a safety risk (e.g., alopecia or vitiligo).
Any unresolved toxicity Grade 2 or more according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) from previous anticancer therapy
Patient with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2; (CTCAE version 4.0)
Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn’s disease, malabsorption, or grade >= 2 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v.4.0 diarrhea of any etiology at baseline)
Potassium, magnesium, corrected calcium or phosphate abnormality of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) > grade 1
Resolution of clinically significant side effects of prior chemotherapy, radiotherapy, immunotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade =< 1 or grade =< 2 for neuropathy
Prior treatment toxicities have not resolved to =< grade 2 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (except clinically insignificant toxicities such as alopecia)
Patient has not recovered from all toxicities related to prior anticancer therapies to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade =< 1 (exception to this criterion: patients with any grade of alopecia are allowed to enter the study).
Any previous National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 4 venous thromboembolism
History of severe hypersensitivity reaction to any monoclonal antibody (grade >= 3 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
Resolution of all acute adverse events resulting from prior cancer therapies to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade less than/equal to 1 or baseline (except alopecia)
With the exception of alopecia, any unresolved toxicities from prior anti-tumor treatments (excluding corticosteroids) should be no greater than Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) grade 1 at the time of study entry
Have resolution, except where otherwise stated in the inclusion criteria, of all clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ?1 by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
At least 2 weeks must have elapsed since the end of prior systemic treatment (4 weeks for bevacizumab-containing regimens) or radiotherapy with resolution of all treatment-related toxicity to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =< 1 (or tolerable grade 2) or back to baseline (except for alopecia, lymphopenia, or hypothyroidism); any number of prior therapies for recurrent/metastatic ACC are allowed
Patient has >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Prior treatment related side effects must have resolved to < grade 2 severity per Common Terminology Criteria for Adverse Events (CTCAE version 4.03), except alopecia and infertility
Subjects who have a history or current evidence of bleeding disorder, i.e. any hemorrhage / bleeding event of CTCAE (Common Terminology Criteria for Adverse Events) Grade ?2 within 4 weeks before the start of study Treatment.
All prior treatment- related toxicities must be National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 <=Grade 1 (except alopecia [permissible at any Grade] and peripheral neuropathy [which must be <= Grade 2]) at the time of treatment allocation.
Ongoing or active infection (bacterial, fungal, or viral) of National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade > 2.
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 3 hemorrhage within 4 weeks of starting the study treatment
No proteinuria Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or greater
Partcipant has not recovered from the acute toxic effects (Common Terminology Criteria for Adverse Events [CTCAE] grade ? 1) of prior anticancer therapy, radiation, or major surgery/significant trauma (except alopecia or other toxicities not considered a safety risk for the particiapants at the Investigator's discretion).
Persistent diarrhea or malabsorption > National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 2, despite medical management
Significant neuropathy per Common Terminology Criteria for Adverse Events (CTCAE) version (ver.) 4.03 or current version (grade 3 and above, or grade 2 with pain) within 14 days prior to enrollment
significant cardiovascular disease within the last 3 months including: myocardial infarction, unstable angina, congestive heart failure, ongoing arrhythmias of Grade >2 [National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.03], thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism). Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
The participant has uncontrolled hypertension, as defined in Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, prior to initiating study treatment, despite antihypertensive intervention.
Peripheral neuropathy Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher
Subjects with toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue that have not resolved to grade 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4) or baseline before administration of study drug
Patients must have recovered from clinically significant, acute, treatment-related toxicities of prior therapies; for those acute baseline adverse events attributable to prior therapy, recovery is defined as a toxicity grade =< 2, using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0, unless otherwise specified in the inclusion and exclusion criteria\r\n* Agents that potentially fit into more than one category or do not clearly fit into any category listed above should be discussed with the study principal investigator (PI) prior to enrollment
Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 from toxicities related to any prior treatment, unless adverse events are clinically non-significant and/or stable on supportive therapy
Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0; in CTCAE version 4.0 grade 2 sensory neuropathy is defined as \moderate symptoms; limiting instrumental activities of daily living (ADLs)\
All acute toxic effects of any prior treatment have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v)4.0 grade 1 or less at the time of signing the informed consent form (ICF)
Ongoing infection > grade 2 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
All acute toxic effects of any prior treatment have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v)4.0 grade 1 or less at the time of signing the informed consent form (ICF)
Following medical conditions are not eligible:\r\n* Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer or cervical dysplasia)\r\n* Any other serious illness or medical condition, such as but not limited to: \r\n** Any infection >= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 grade 2\r\n** Cardiac failure New York Heart Association (NYHA) III or IV\r\n** Crohn’s disease or ulcerative colitis\r\n** Bone marrow dysplasia or myelodysplastic syndrome
Any unresolved toxicity CTCAE (Common Terminology Criteria of Adverse Events) >Grade 2 from previous anti-cancer therapy
Prior therapy (chemotherapy, radiation therapy, and surgery) is allowed if completed at least 2 weeks prior to registration and if all treatment-related toxicities are resolved to =< Common Terminology Criteria for Adverse Events (CTCAE) grade 1, with the exception of alopecia and hematologic values otherwise meeting the bone marrow function criteria
The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03 grade =< 1 from adverse events (AEs) (except alopecia, anemia and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other medications that were administered prior to study drug
Has gastrointestinal bleeding or any other hemorrhage/bleeding event Common Terminology Criteria for Adverse Events (CTCAE) grade > 3 within 6 months of start of study drug
Electrocardiography (EKG) corrected QT (QTc) < 480 msec (Common Terminology Criteria for Adverse Events [CTCAE] grade 2)
Patient has >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety
Peripheral edema >= grade 2 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4 grade =< 1 (except alopecia) at the time of enrollment
Patients must have recovered from effects of recent surgery, radiotherapy, chemotherapy or biologic/targeted therapy to baseline or Common Terminology Criteria for Adverse Events (CTCAE) less than or equal to grade 1 (excluding alopecia or other non-clinically significant adverse events [AE's])
All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 4.03) or baseline before administration of study drug; subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long-lasting sequelae, such as neuropathy after chemotherapy, are permitted to enroll
Any hemorrhage or bleeding event >= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4 grade 3 =< 4 weeks prior to registration
All treatment related toxicities, except alopecia, must have recovered to Grade 1 or better (Common Terminology Criteria for Adverse Events (CTCAE); version 4.0) prior to administration of the first dose of study treatment.
With the exception of alopecia, any unresolved toxicities from prior chemotherapy should be no greater than Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) grade 1 at the time of starting study treatment
Persistent grade > 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0) adverse events (AEs) due to investigational drugs that were administered more than 14 days before study enrollment with the exception of alopecia
Any other serious illness or medical condition in the opinion of the investigator, such as but not limited to:\r\n* Any grade >= 2 infection as defined by National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 \r\n* Cardiac failure New York Heart Association (NYHA) III or IV\r\n* Crohn’s disease or ulcerative colitis\r\n* Bone marrow dysplasia\r\n* Fecal incontinence
Participant has peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the national cancer institute common terminology criteria for adverse events (NCI CTCAE) Version 4
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade =< 1 (except alopecia); Grade 2 prior treatment related toxicities may be allowed after discussion with the Principal Investigator
Unresolved toxicities from any prior therapy greater than Common Terminology Criteria for Adverse Events Grade 1 at the time of starting study treatment with the exception of alopecia.
Neuropathy (sensory) =< Common Terminology Criteria for Adverse Events (CTCAE) grade 1
All acute toxic effects of any prior treatment have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0) grade 1 or less at the time of signing the Informed Consent Form (ICF)
? Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 thrombocytopenia, OR
At least 2 weeks must have elapsed since the end of prior systemic treatment (4 weeks for bevacizumab- containing regimens) or radiotherapy with resolution of all treatment-related toxicity to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =< 1 (or tolerable grade 2) or back to baseline (except for alopecia, lymphopenia, or hypothyroidism); any number of prior therapies for recurrent/metastatic ACC are allowed
Recovered from toxicities related to prior anticancer therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, v4.0) grade ?2.
Patients with peripheral neuropathy > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Has not recovered (recovery is defined as National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE version (v)4.03] grade =< 1) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting the inclusion requirements stated in the inclusion criterion
Resolution of all acute toxic effects of prior chemotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade < 1, in the opinion of the Treating Physician
Any acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) (version 4) grade of =< 1; chemotherapy induced alopecia and grade 2 peripheral neuropathy are allowed
Participants must have recovered from the acute toxic effects of prior therapy to a grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] v.4.0) level prior to enrollment (does not apply to alopecia)
Have resolution of all acute toxic effects of any prior chemotherapy or radiotherapy to National Cancer Institute Common Terminology Criteria (NCI CTC) grade =< 1 prior to study registration
Participants with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) grade =< 1 (except alopecia) at the time of enrollment
Subjects must have recovered from the acute toxicities of all prior therapy before entering this study; for those acute baseline adverse events attributable to prior therapy, recovery is defined as a toxicity grade =< 2, using Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0, unless otherwise specified in the inclusion and exclusion criteria
The patient has ? Grade 2 peripheral neuropathy by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) at screening
Persistent Common Toxicity Criteria for Adverse Effects (CTCAE v4.0) greater than or equal to grade 2 diarrhea regardless of etiology.
Toxicities of prior therapy (excepting alopecia) should be resolved to =< grade 1 per the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Presence of any unresolved >=Grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) toxicity from previous anti-cancer therapy at the time of enrollment, except alopecia or Grade 2 anemia. Subjects with MM who have ?Grade 2 peripheral neuropathy (per CTCAE v4.0) are permitted.
Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn's disease, malabsorption, or Common Terminology Criteria for Adverse Events (CTCAE) grade > 2 diarrhea of any etiology
Unresolved toxicity from other agents. Patients with unresolved Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 grade 3 or greater toxicity from prior administration of another investigational drug and/or anti-cancer treatment are not eligible.
Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia.
Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03 grade >= 3)
Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (prior to the first dose of study therapy, or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Gr 1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier
Unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) => Grade 2
Adequate pulmonary function, defined as ? Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 dyspnea and saturated oxygen (SaO2) ? 92% on room air
Participant has significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn’s disease, malabsorption, or grade >= 2 [National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0] diarrhea of any etiology at screening)
Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 5), grade =< 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia
Any acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4) grade of =< 1; chemotherapy induced alopecia and grade 2 peripheral neuropathy are allowed
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or systemic infection requiring IV antibiotic therapy within 14 days preceding the first dose of study drug
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or systemic infection requiring IV antibiotic therapy within 14 days preceding the first dose of study drug
Pre-existing neuropathy >= grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.0)
Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) grade 2 or higher from previous anti-cancer therapy, except alopecia
All acute toxic effects of any prior treatment have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0 grade 1 or less at the time of signing the informed consent form (ICF)
Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 5), grade =< 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia
Subjects who have not recovered from toxicities as a result of prior anticancer therapy to less than Grade 2 severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0, except alopecia and infertility.
Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, hormonal therapy, or surgery to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =< 1, except for diarrhea (which must be grade 0 without supportive antidiarrheal medications) and alopecia (any grade)
Ongoing infection > grade 2 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0)
Unresolved diarrhea >= Common Terminology Criteria for Adverse Events (CTCAE) version 4, grade 1
Any other serious illness or medical condition, such as but not limited to: Any active infection >= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2; Cardiac failure New York Heart Association (NYHA) III or IV; Fecal incontinence (this is because of Ra-223 elimination in feces).
Last chemotherapy or treatment with another systemic anti-cancer agent must have stopped >= 4 weeks prior to enrollment (or >= 5 half-lives for oral tyrosine-kinase inhibitors or 2 weeks for palliative radiotherapy); participants must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] =< 1 or baseline) from acute toxicities of any previous therapy (with the exception of alopecia)
Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4) resulting from prior therapy must be < grade 2
All acute toxic effects of any prior treatment have resolved to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (v4.0) grade 1 or less at the time of signing the informed consent form (ICF)
Clinically significant active gastrointestinal (GI) bleeding (Grade >/=2 according to National Cancer Institute [NIC]-Common Terminology Criteria for Adverse Events Version 4.0 [CTCAEv.4.0])
Ongoing infection > Grade 2 according to NCI-CTCAE (National Cancer Institute - Common Terminology Criteria for Adverse Events) v. 4.0. Hepatitis B is allowed if no active replication is present. Hepatitis C is allowed if no antiviral treatment is required.
Resolution of chemotherapy and radiation therapy related toxicities to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 Grade 1 or lower severity, except for diarrhea (which must be Grade 0 without a supportive antidiarrheal medications) and alopecia (any grade)
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) =< grade 1 (except alopecia) at the time of enrollment
Gastrointestinal bleeding or any other hemorrhage/bleeding event Common Terminology Criteria for adverse Events (CTCAE), v. 4 grade 3 or greater within 30 days prior to registration
Resolution of all clinically significant toxic effects of prior cancer therapy to grade ?1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v.4.0)
Prior anti-cancer treatment related toxicities except alopecia and lab values as outlined above must be =< grade 1 as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4
Patients that have not recovered from adverse events related to prior chemotherapy, radiation therapy or multikinase inhibitors to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 grade 1 or less except for alopecia
Symptomatic peripheral neuropathy >= grade 2 by National Cancer Institute (NCI) Common Terminology Criteria (NCI-CTC) version 4
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies, including surgery, except alopecia and other non-clinically significant adverse events (AEs)
Have a grade 2 or greater laboratory abnormalities (Common Terminology Criteria for Adverse Events version 4 [CTCAE v4]) at baseline for any of the following:\r\n* Hemoglobin\r\n* White blood cell count\r\n* Platelet count\r\n* Alanine transferase\r\n* Aspartate transferase\r\n* Creatinine
Unresolved toxicities from prior systemic therapy that are Common Terminology Criteria in Adverse Events (CTCAE) version 3.0 or 4.0 >= grade 2 in severity except alopecia
Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event ? CTCAE Grade 3 within 4 weeks of start of study medication (CTCAE: Common Terminology Criteria for Adverse Events).
Diarrhea, grade 1 or greater by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version [v.] 4.0); pancreatic cancer patients with clinical evidence of pancreatic insufficiency must be taking pancreatic enzyme replacement
Patients with =< grade 1 peripheral neuropathy are eligible for this trial using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0, regardless of use of therapy for neuropathy including gabapentin
Subjects with baseline symptoms of fever and/or cough and/or shortness of breath and/or wheezing and/or fatigue grade >= 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.0)
Ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade >= 2
The participant has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
Any unresolved chronic toxicities > grade 2, measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4 (v4)
Patients must have recovered to =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4 from toxicity of prior chemotherapy or biologic therapy and must not have had prior chemotherapy or biologic therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C, 8 weeks for 7-hydroxystaurosporine [UCN-01])
Resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v.)3.0 grade =< 1 and to baseline laboratory values as defined in the inclusion criterion immediately below
Any unresolved toxicity greater than Grade 2 , except for alopecia, (National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 4.0) from parent study treatment at the time of transition to this study.
Resolution of all toxic side effects of prior chemotherapy, radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.03) grade =< 1 (with the exception of grade 2 alopecia, grade 2 neuropathy and grade 2 fatigue)
Clinically significant peripheral neuropathy (defined as >= Common Terminology Criteria for Adverse Events [CTCAE] grade 2 [version 4.0]), neurosensory or neuromotor toxicity, regardless of causality
Neuropathy (sensory and motor) =< grade 1 according to Common Toxicity Criteria for Adverse Events version 3 (CTCAE)
Subjects must be recovered from any toxicity related to prior anti?neoplastic therapy (to grade =< 1); patients with Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or less sensory neuropathy or any grade alopecia are eligible
History of persistent Grade 2 or higher hematological toxicity according to National Cancer Institute-Common Toxicity Criteria Version 4.0
Previous radiation allowed provided the patient has recovered from the acute and chronic side effects to =< grade 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events v. 4.0 [CTCAE v 4.0])
Patients with active diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE version 4) grade 2 at the time of signing consent
Any chemotherapy related toxicities from prior treatment (>= grade I per Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0)
Diarrhea > grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading, in the absence of antidiarrheals
History of bleeding (hemoptysis in excess of 2.5 mL or one-half teaspoon, hematuria, gastrointestinal [GI] blood loss, epistaxis, or others with greater than grade 1 according to Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) within 1 month prior to beginning therapy or any clinical indications of current active bleeding
Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =< 1
Patients with known grade 3 or higher (per Common Terminology Criteria for Adverse Events [CTCAE] version 4.0 [v.4.0] criteria) active systemic or cutaneous viral, bacterial, or fungal infection
Patients with gastrointestinal bleeding or any other hemorrhage/bleeding event Common Terminology Criteria for Adverse Events (CTCAE) grade >= 3 within 30 days prior to study entry
Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) Grade 2 or higher from previous anti-cancer therapy, except alopecia;
E 04. Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization.
E 19. Symptomatic peripheral neuropathy grade >2 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v.4.03).
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Ongoing infection > grade 2 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0)
Any unresolved toxicity > Grade 2 (National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 4.0) from parent study treatment, except for alopecia, will need to be approved by the GSK Medical Monitor
Resolution of any pre-existing toxicity from prior therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 =< grade 1 except neuropathy (=< grade 2) and tinnitus (=< grade 2), and hearing loss (=< grade 4)
Prior systemic chemotherapy for the study cancer (sarcoma); note that prior chemotherapy for a different cancer is allowable; however, unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade 0 or 1, or to levels dictated in the eligibility criteria with the exception of alopecia (grade 2 or 3 toxicities from prior anti-tumor therapy that are considered irreversible [defined as having been present and stable for > 6 months], such as ifosfamide-related proteinuria, may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and sponsor)
At least 2 weeks must have elapsed since the end of prior systemic treatment and/or 4 weeks since completion of radiotherapy with resolution of all treatment-related toxicity to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 grade =< 1 (or tolerable grade 2) or back to baseline (except for alopecia, lymphopenia, or hypothyroidism) prior to starting study drug treatment; any number of prior therapies for recurrent/metastatic salivary gland cancer are allowed
Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03 grade >= 3)
Prior anti-PD-L1 therapies are excluded\r\n* Patients who have received prior treatment with immunotherapy including anti-PD-1 anti-CTLA-4 may be enrolled, provided that there was no history of severe immune-related adverse effects (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] grade 3 and 4)
Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia;
Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4.0), grade 0 or 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia
Any unresolved clinically significant treatment related toxicity of >= grade 1 intensity, as assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), from previous anti-cancer therapy; patients with irreversible toxicity (eg, hearing loss, peripherally neuropathy) or reversible toxicity (eg, alopecia) that is not reasonably expected to be exacerbated by the investigational product and is not expected to interfere with study participation may be included
Toxicities of prior therapy (except alopecia) should be resolved to less than or equal to grade 1 as per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0); patients with long-standing stable grade 2 neuropathy may be considered after discussion with the overall principal investigator (PI)
Has not recovered (i.e., equivalent to a Common Terminology Criteria for Adverse Events [CTCAE] ?Grade 2) from the clinically significant toxic effects of prior anticancer therapy. Exception: subjects who have received treatment with a proteasome inhibitor such as bortezomib may have CTCAE Grade 2 neuropathy.
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) version (v)4 grade =< 1 (except alopecia) prior to the first dose of the study drug
Has unresolved, clinically significant toxicities from prior anti-cancer therapy defined as > Grade 1 on Common Terminology Criteria for Adverse Events.
Lack of recovery of prior cancer therapy-related adverse events to grade =< 1 (NCI Common Terminology Criteria for Adverse Events [CTCAE] v4.03; except alopecia); stable persistent grade 2 peripheral neuropathy may be allowed as determined on a case-by-case basis at the discretion of the principal investigator (PI); patients with platinum-related grade 2 or greater hypomagnesemia (on replacement) will be eligible
Has had chemotherapy, radiation, or biological cancer therapy within 4 weeks prior to the first dose of study therapy, or who has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from the adverse events due to cancer therapeutics administered more than 4 weeks earlier
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Clinically significant peripheral neuropathy at the time of randomization (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v4.0] as grade 2 or greater neurosensory or neuromotor toxicity)
All prior treatment-related toxicities must be National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.0 <=Grade 1 at the time of enrollment (except for alopecia)
Patients who have not recovered (Common Terminology Criteria for Adverse Events [CTCAE] =< grade 1) from adverse events due to prior treatments, except for alopecia, or base stable grade 2 tinnitus (not interfering with activities of daily living [ADL]’s) or stable grade 2 sensory neuropathy without pain or motor component, and not interfering with ADL’s
Patients must have completed surgical resection and adjuvant chemotherapy (adjuvant radiotherapy excluded) with no significant persisting treatment related toxicity (grade 1 toxicity per Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0 allowed) as determined by the treating physician
Has persistent grade >1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia). Stable sensory neuropathy ? grade 2 National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 is accepted
History of severe (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03 grade 3 or higher) allergic reaction to a drug, vaccination, or biological preparation
Persistent proteinuria >= grade 3 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 (> 3.5 g/24 hours [hrs], measured by urine protein: creatinine ratio on a random urine sample)
Known unresolved toxicities due to prior anticancer therapy, defined as not having resolved to grade 0 or 1 (by Common Terminology Criteria for Adverse Events [CTCAE] version 4 criteria), unless otherwise defined in the inclusion/exclusion criteria with the exception of alopecia
Treatment with any anticancer therapy (standard or investigational) within the 14 days prior to the first dose of study drug. In addition, subjects must have fully recovered (i.e., National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] Grade 1 [exception: subjects with prior bortezomib may have CTCAE Grade 2 neuropathy]) from the clinically significant toxic effects of that treatment
Recovery from acute toxicity of prior treatment for renal cell carcinoma (RCC) (to =< grade 1 the active version of Common Terminology Criteria for Adverse Events [CTCAE] or to a level permitted under other sections of inclusion/ exclusion criteria); additionally, in patients who have received standard or experimental treatments for their RCC at least approximately 5 half-lives should have elapsed from the last dose at the time of study entry
Ongoing or active infection of Common Terminology Criteria for Adverse Events (CTCAE) Grade ? 3
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Absolute neutrophil count (ANC) greater than or equal to 1,500/ul, equivalent to Common Toxicity Criteria (Common Toxicity Criteria for Adverse Events [CTCAE] version [v.]4.0) grade 1
Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4.03), Grade 0 or 1, unless otherwise defined in the inclusion/exclusion criteria with the exception of alopecia.
Any hemorrhage or bleeding event >= National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 3 within 4 weeks prior to start of study medication
All acute toxic effects of any prior treatment have resolved to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (v4.0) grade 1 or less at the time of signing the informed consent form (ICF); alopecia (any grade) and peripheral neuropathy < grade 2 is allowed
Resolution of all toxic effects of prior treatments except alopecia to Grade 0 or 1 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Resolution of all toxic effects of prior treatments except alopecia to Grade 0 or 1 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Acute toxic effects of all prior treatment have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v)4.0 =< grade 1 or baseline prior to beginning treatment; alopecia (any grade) is allowed; peripheral neuropathy =< grade 2 is allowed
Lack of recovery of prior adverse events to Grade ?1 severity (National Cancer Institute Common Terminology Criteria for Adverse Events version 4) (except alopecia) due to therapy administered prior to the initiation of study drug dosing.
Failure to recover to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 2 from clinically significant toxicities due to prior cancer therapies or to any investigational agents
Pts who have grade III-IV elevations in liver transaminases (as defined by the Common Terminology Criteria for Adverse Events [CTCAE] version [v.] 4.0) or a bilirubin in excess of 1.5 mg/dl
Unresolved toxicity greater than Grade 1 National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4 from previous anti-cancer therapy, with the exception of alopecia and peripheral neuropathy. Lymphoma subjects with <= Grade 3 lymphopenia can be enrolled at the discretion of the investigator.
Recovered from toxic effects of prior therapy to < Grade 2 toxicity per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) prior to Day 1. Minimum duration required between prior therapy & Day 1 is:
Active clinically serious infections [> Grade 2 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0]
Resolution of any toxic effects of prior therapy (including radiotherapy) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0, grade =< 1 (with the exception of alopecia and =< grade 2 neuropathy); subject must have recovered from significant surgery-related complications
Prior treatment toxicities must be resolved to =< grade 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Patients must have recovered from toxicity related to prior therapy (chemotherapy, surgery or radiation) to grade =< 1 (defined by Common Terminology Criteria for Adverse Events [CTCAE]); the National Cancer Institute (NCI) CTCAE version 4 will be used for toxicity and adverse event reporting
All acute toxic effects of any previous radiotherapy, chemotherapy, or surgical procedures must have resolved to grade 1 or lower according to Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0)
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Patients must not have >= grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Absolute neutrophil count (ANC) >= 1,500/mcl, equivalent to Common Terminology Criteria (CTCAE version [v] 4.03) grade 1
Patients who have not recovered from adverse events of prior therapy to =< National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 1
Pre-existing peripheral neuropathy (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] ?2)
< grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Existing anticancer treatment-related toxicities of Grades >= 2 (except for alopecia and Grade 2 sensory neuropathy) according to Common Terminology Criteria for Adverse Events (CTCAE v4.03).
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs) defined as lab elevation with no associated symptoms or sequelae
All acute toxic effects of any previous radiotherapy, chemotherapy, or surgical procedures must have resolved to grade I or lower according to Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0)
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Presence of peripheral neuropathy ? Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
Patients with pre-existing neuropathy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (motor or sensory)
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
Have not recovered (recovery is defined as National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] grade ? 1) from the acute toxicities of previous therapy, except treatment related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
Anxiety ? Common Terminology Criteria (CTC) of adverse events (AE) grade 3.
Unresolved toxicity of Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater from previous anti-cancer therapy or radiotherapy
Have discontinued previous treatments for cancer and have resolution, except where otherwise stated in the inclusion criteria, of all clinically significant toxic effects of prior chemotherapy, surgery, or radiotherapy to Grade ?1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 (v 4.0).
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) version (V) 5 grade =< 1 (except alopecia); certain exceptions apply, such as immunotherapy-induced hypothyroidism or adrenal insufficiency or panhypopituitarism requiring stable doses of hormone replacement or rash from prior therapy
Clinically significant peripheral neuropathy at the time of randomization (defined in the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v4.0] as grade 2 or greater neurosensory or neuromotor toxicity)
Central nervous system function defined as:\r\n* Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and if seizures are well controlled\r\n* Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version 4 [v4]) resulting from prior therapy must be =< grade 2
Ineligible for cisplatin-based chemotherapy as defined by any one of the following criteria: Impaired renal function (glomerular filtration rate [GFR] > 30 but < 60 milliliter/minute [mL/min]); National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0 Grade >= 2 audiometric hearing loss (of 25 Decibel at two contiguous frequencies or more severe); NCI CTCAE v 4.0 Grade >= 2 peripheral neuropathy; ECOG Performance Status of 2
Acute toxicities from any prior treatment, surgery, or radiotherapy must be National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade less than or equal to (<=) 1
Unresolved toxicity >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 from previous anti-cancer therapy except alopecia or long-term radiation toxicity (radiation related toxicity 3 months or greater after radiation exposure)
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Preexisting peripheral neuropathy of grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v 4.0)
Clinically significant non-hematologic toxicity after prior therapy has recovered to grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 or newer
Subject must have recovered from the effects of prior systemic antineoplastic or radiation therapy(s) to ? Grade 1 (National Cancer Institute - Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version 4.0) severity or to subject's baseline values, excluding alopecia.
Subject who has an ongoing toxicity ? Grade 2 (Common Terminology Criteria for Adverse Event [CTCAE] v4.03) attributable to prior medication to treat solid tumor (except alopecia) at the time of screening.
Unresolved non-hematologic toxicities from prior therapies that are > Common terminology Criteria for Adverse Events (CTCAE) Grade 1 (with the exception of alopecia [Grade 1 or 2 permitted])
Resolution of all transplant-related toxicity to =< grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) version (v.)4
Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.0) at the time of randomization.
Resolution to grade =< 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.03) of all clinically significant toxic effects of prior anti-cancer therapy (with the exception neuropathy, which may be =< grade 2 within 14 days prior to cycle 1 day 1)
Patients must not have grade 2 or greater pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE] 4.0)
Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4), grade =< 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia
Any acute toxicities due to prior anti-cancer treatments and/or radiotherapy that have not resolved to a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade of =< 1 (except alopecia)
Patients may not have any baseline comorbidities or laboratory abnormalities which would be of grade 3 or worse if graded as toxicities by Common Terminology Criteria for Adverse Events (CTCAE) (excepting alopecia); an exception is also made for neurologic comorbidities (e.g. ataxia, aphasia) arising as a consequence of the brain tumor; symptoms severe enough to warrant medical treatment as is offered on this study are by definition grade 3
Active, clinically serious infections defined as ?Grade 2 according to NCI Common Toxicity Criteria for Adverse Effects (CTCAE), version 4.0
toxicity attributed to previous anticancer therapy that did not resolve to Common Terminology Criteria for Adverse Events (CTCAE) grade =1
Recovery from all reversible AEs of previous medical therapies to baseline or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 1, except for alopecia (any grade)
Adverse events (with exception of alopecia, peripheral sensory neuropathy and those listed in specific exclusion criteria) from any prior anti cancer therapy of grade > 1 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] version [v.]4.0)
Skin rash Common Terminology Criteria for AEs (CTCAE) Grade greater than 1 from previous anti-EGFR therapy at time of randomization
Has gastrointestinal bleeding or any other hemorrhage/bleeding event National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) >Grade 3 within 6 months of start of study drug.
All prior anti-cancer treatment-related toxicities (except alopecia and laboratory values as listed in the protocol) must be <=grade 1 according to the Common Terminology Criteria for Adverse Events version 4 (CTCAE version 4.0) at the time of randomization.
Peripheral neuropathy of grade >= 2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, at the time of or within 3 weeks prior to the first study therapy
History of severe (using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 4.0 [NCI-CTCAE] v4 current minor version ? grade 3) allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients
Subject has persistent nonhematological toxicities of >= Grade 2 (Common Terminology Criteria for Adverse Events v4), with symptoms and objective findings, from prior AML treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, or surgery).
Have peripheral neuropathy of grade 3 or grade 4 at screening, according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version (v)4.03, 14 June 2010 scale; or Total Neuropathy Score–clinical (TNSc) score greater than 4
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) version (v)4 grade =< 1 (except alopecia) at the time of randomization and crossover
Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (CTCAE v4.0) Grade 2 or higher from previous anti-cancer therapy, except alopecia
Proteinuria by Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or greater
Ongoing cardiac dysrhythmia >= 2 (per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [NCI CTCAE, v4.0])
Patients must have < grade 2 pre-existing peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE)
The subject has not recovered from toxicity due to prior therapy to Baseline level or National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0) Grade 1 or less (except alopecia). Residual chemotherapy-induced neuropathy grade less than equal to (<=) 2 is permitted.
Recovery to CTCAE (Common Terminology Criteria for Adverse Events Version 4.03) Grade 0 or Grade 1 or recovery to baseline preceding the prior treatment of any previous drug / procedure-related toxicity (except alopecia, anemia, and hypothyroidism)
Active infections of CTCAE (Common Terminology Criteria for Adverse Events Version 4.03) Grade >2 or infections of CTCAE Grade 2 not responding to therapy
Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 (NCI CTCAE version 4.03) Grade 2 or higher from previous anti-cancer therapy, except alopecia.
Documented hypersensitivity (Common Terminology Criteria for Adverse Events [CTCAE] grade >= 2) to any drug containing polysorbate 80
Current peripheral neuropathy of grade >= 3 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.0
All non-hematological adverse events of any prior chemotherapy, surgery or radiotherapy must have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade less than or equal to (</=) 2 prior to starting therapy
All prior anti-cancer treatment-related toxicities (except alopecia) must be <= Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 at the time of enrollment
The subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0; in CTCAE version 4.0 grade 2 sensory neuropathy is defined as \moderate symptoms; limiting instrumental activities of daily living (ADLs)\
Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies (but excluding nitrosourea, mitomycin-C, targeted therapy and radiation) =< 3 weeks prior to starting study drug, or who have side effects (except alopecia, lymphopenia and hyperglycemia) that have not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or less
Grade 2 or worse edema within 14 days to study day 1, per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) Grade 2 or higher from previous anti-cancer therapy, except alopecia.
All acute toxic effects of any prior treatment have resolved to grade 1 or less (by National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] v 4.0) at the time of registration; NOTE: exceptions to this criterion will include alopecia and fatigue
Pulmonary hemorrhage/bleeding event > National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4.0) grade 2 within 4 weeks of enrollment
Unresolved toxicity greater than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 Grade 2 or higher from previous anti-cancer therapy, including major surgery except those that in the opinion of the investigator are not clinically relevant given the known safety/toxicity profile of dabrafenib (e.g., alopecia and/or peripheral neuropathy related to platinum or vinca alkaloid based chemotherapy).
The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
Any unresolved chronic toxicity with Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2, from previous anti-NF1 therapy, except for alopecia
Platelet count ? 50,000/µL, with or without transfusion support; platelet count < 50,000/µL but ? 20,000/µL, with or without transfusion support, is permissible if the subject has not had Grade ? 2 bleeding in the prior 6 months (where grading of the bleeding is determined per the National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE], version 5.0)
Participants with evidence of electrolyte imbalance such as hypokalemia, hyperkalemia, hypocalcemia, hypercalcemia, hypomagnesemia, and hypermagnesemia of Grade > 1 intensity, as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0, prior to dosing on Cycle 1 Day 1. Treatment for correction of electrolyte imbalances is permitted to meet eligibility
History of persistent Grade 2 or higher (National Cancer Institute Common Terminology Criteria [NCI-CTC], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
Must have recovered from any acute toxicity related to prior therapy, including surgery; toxicity should be =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version 4 or has returned to baseline; alopecia > grade 1 is permitted
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Adequate recovery from prior therapy, all side effects (except alopecia) have resolved to Grade 1 or less according to the National Cancer Institute - Common Terminology Criteria of Adverse Events (NCI-CTCAE) Version 4.0
Subjects who have not recovered from acute toxicities as a result of prior anti-cancer therapy to less than or equal to Grade 1, according to Common Terminology Criteria for Adverse Events (CTCAE), except for peripheral neuropathy (see Exclusion 6) and alopecia.
Proteinuria Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher.
All toxicities from prior therapies must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade I or better by the time of study enrollment
Has AEs that have resolved to Grade ? 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v 4.0) from all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy,or hormonal therapy
Presence of peripheral edema > Grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version 4)
Pulmonary hemorrhage/bleeding event >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 within 4 weeks of first dose of study drug
Patients with diarrhea > Common Terminology Criteria for Adverse Events Version 4 (CTCAE V.4) grade 2
Presence of neuropathy > grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) at baseline
Unresolved toxicity greater than National Cancer Institute-Common Terminology Criteria for Adverse Events version 4 Grade 1 from previous anti-cancer therapy except alopecia.
Patients who have not recovered (Common Toxicity Criteria [CTC] =< grade I) from adverse events due to prior treatments
Pulmonary hemorrhage/bleeding event >= Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 within 4 weeks of first dose of study drug
Prior chemotherapy and/or radiation are allowed; at least 3 weeks must have elapsed since prior large-field radiation therapy; patients must have been off previous anti-cancer therapy for at least 3 weeks (6 weeks for mitomycin-C and nitrosoureas); and recovered from all treatment related toxicity to =< grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (with the exception of alopecia and radiation-induced taste changes); prior temozolomide treatment is not restricted
Current peripheral neuropathy greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 except due to trauma
Neuropathy ? Grade 3 or painful neuropathy ? Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v3.0).
Not recovered from side effects of prior therapy to ? grade 1 (according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [NCI CTCAE v. 4.03]). Certain side effects that are unlikely to develop into serious or life-threatening events (e.g. alopecia) are allowed at > grade 1
Patients must have recovered from acute toxicities resulting from therapy administered prior to entering this study to grade 1 or less (Common Terminology Criteria for Adverse Events [CTCAE] 4); alopecia may be unresolved
Patients must have =< grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE] v4.0)
Subject has an ongoing toxicity ? Grade 2 (Common Terminology Criteria for Adverse Event [CTCAE] v4.03) attributable to prior medication to treat solid tumor (except alopecia) at the time of screening.
Presence of >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 toxicity (except alopecia) due to prior therapy
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade =< 1 (except for adverse events [AEs] not considered to be dose-limiting toxicities [DLTs] in this trial such as alopecia and lymphopenia) at the time of enrollment; if there are any questions, please contact the study's principal investigator
Resolution to grade =< 1 by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03) of all clinically significant toxic effects of prior anti-cancer therapy (with the exception neuropathy, which may be =< grade 2 within 14 days prior to cycle 1 day 1)
Patients must have recovered from all toxicities related to prior anticancer therapies to =< grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.03); exception to this criterion: patients with any grade of alopecia are allowed to enter the treatment
Any hemorrhage or bleeding event >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 within 4 weeks prior to start of study medication
Presence of >= grade 3 non-hematologic toxicity common terminology criteria (CTC) version 4 from the previous treatment
Recovered from adverse events (to grade 1 or less toxicity according to Common Terminology Criteria for Adverse Events [CTCAE] 4.0) due to agents administered previously; NOTE: chemotherapy-induced alopecia and grade 2 neuropathy are acceptable
Patients with pre-existing peripheral neuropathy must have < grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] 4.0) at the time of registration
Patient has >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety
Newly diagnosed clinical grade 2 or higher radiation pneumonitis according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria
All acute toxicities as a result of any prior treatment must have resolved to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 1 or less at the time of signing the Informed Consent Form (ICF) (Note: ongoing grade 2 neuropathy as a result of treatment with a cytotoxic chemotherapy regimen is permitted)
Any other serious illness or medical condition, such as but not limited to: \r\n* Any infection >= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 grade 2\r\n* Cardiac failure New York Heart Association (NYHA) III or IV \r\n* Crohn’s disease or ulcerative colitis \r\n* Bone marrow dysplasia \r\n* Fecal incontinence
Toxicities of prior therapy (excepting alopecia and sensory neuropathy) should be resolved to < grade 2 per the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4; all appropriate treatment areas should have access to a copy of the CTCAE version 4
Diarrhea < grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version 4
Moderate-to-severe bone pain (i.e., National Cancer Institute’s Common Terminology Criteria for Adverse Events grade 2-3 bone pain)
Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher proteinuria
Depression >= grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.0)
Hepatic or renal toxicity (glomerular filtration rate [GFR] < 30) greater than or equal to grade 2 (using Common Terminology Criteria for Adverse Events [CTCAE] version 4 standard definitions)
Any vomiting, retching or National Cancer Institute (NCI) Common Toxicity Criteria version 4.0 grade 2-4 nausea 24 hours preceding chemotherapy
Have grade 1 or 2 symptomatic dry mouth (xerostomia) according to CTEP NCI Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
Known history of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) grade >= 2 symptomatic chronic heart failure (CHF), myocardial infarction within 12 months prior to randomization, significant symptoms (grade >= 3) relating to left ventricular dysfunction, significant (moderate or severe) valvular disease, or significant cardiac arrhythmia (grade >= 3)
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events 4.03 [CTCAE 4.03])
Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4.03), grade =< 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia
All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version 4) or baseline before administration of study drug; subjects with toxicities attributed to prior anti-cancer therapy and which are not expected to resolve and result in long lasting sequelae such as neuropathy after platinum-based therapy, are permitted to enroll
Peripheral neuropathy grade 0 or 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
The patient has recovered to grade =< 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 (NCI-CTCAE v4.03) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies, with the exception of alopecia; the exceptions for such effects are allowed lab values of =< grade 2 specified elsewhere in these inclusion criteria
Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade <=1 severity (Common Terminology Criteria for Adverse Events [CTCAE] v4.03, or later versions)
Reporting grade 1 or greater of the following symptoms persistently for more than 2 weeks: neuropathic pain, allodynia, areflexia, dysesthesia, paresthesia, hyperesthesia, hypoesthesia or glove and stocking syndrome as defined by Common Terminology Criteria for Adverse Events (CTCAE version [v.] 4.03)
Patients with a National Cancer Institute (NCI)-Common Toxicity Criteria (CTC) version (v) 4 sensory neuropathy score of 0
EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Unresolved toxicities from prior anti cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4), grade =< 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia
Any vomiting, retching, or National Cancer Institute (NCI) Common Toxicity Criteria version 4.0 grade 2-4 nausea in the 24 hours(hrs.) preceding radiation and chemotherapy
All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events, version 4) must be <=Grade 1 at the time of enrollment except for alopecia, and grade 2 neuropathy.
Presence of any toxicities attributed to prior anti-cancer therapy that are not resolved to grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) or baseline before administration of study drug
Complete recovery to baseline or Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 from adverse effects of prior surgery, radiotherapy, endocrine therapy, and other therapy, as applicable, with the exception of Grade 2 alopecia from prior chemotherapy
Potassium, < 4.0 mmol/L despite supplementation; or above the Common Terminology Criteria for Adverse Events (CTCAE) grade 1 upper limit
No clinically relevant deviations in renal function (serum creatinine > grade 2 Common Terminology Criteria for Adverse Events [CTCAE] version 4.0); maximal interval between confirmation of renal function and injection of 18F FSPG is 1 week
Acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) grade of =< 1; chemotherapy-induced alopecia and grade 2 peripheral neuropathy are allowed
With the exception of alopecia, any unresolved toxicities from prior anti-tumor treatments (excluding corticosteroids) should be no greater than Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) grade 1 at the time of study entry
Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03 grade >= 3)
Known severe (National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03 grade 3 or 4) infusion-related allergy or acute hypersensitivity reaction attributed to any monoclonal antibody, any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
Has not recovered to Common Toxicity Criteria for Adverse Events Grade 1 or better from the adverse events due to cancer therapeutics administered more than 4 weeks prior to the first dose of study treatment
Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, or surgical procedure to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade =< 2
Recovery from toxic effects of prior therapies to grade 1 or better according to National Cancer Institute-Common Terminology Criteria of Adverse Events (NCI-CTCAE), version (v) 4
CLINICAL SYMPTOMS (EACH AT LEAST GRADE 1 BY COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS [CTCAE] DEFINITIONS)
Sensory or motor neuropathy of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade >=3.
The participant has not recovered from Adverse Events due to agents administered more than 4 weeks earlier. Neurotoxicity, if present, must have improved to Grade less than 2 per the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 3.0.
The participant has not recovered from adverse events due to agents administered more than 4 weeks earlier. Neurotoxicity, if present, must have improved to Grade less than 2 per the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 3.0.
Participants must not have residual adverse events from previous therapy greater than Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) grade 2 at the time of registration
Patients who have an active clinically significant infection of the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grade ? 2
All chemotherapy or radiation-related toxicities must have resolved to Grade <2 severity per Common Terminology Criteria for Adverse Events (CTCAE v4.03), except alopecia and infertility.