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
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
9. Unresolved toxicities from prior anticancer therapy defined as having not resolved to baseline or to Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria with the exception of alopecia;
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
Unresolved toxicities from prior antitumor therapy, defined as not having resolved to CTCAE, version 4.0 grade 1 (with the exception of myelosuppression, eg, neutropenia, anemia, thrombocytopenia), or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior antitumor therapy that are considered irreversible (defined as having been present and stable for > 2 months) 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 sponsor.
Participant has unresolved, clinically significant toxicities from prior anticancer therapy, defined as greater than Grade 1 on Common Terminology for adverse events.
Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment
Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment
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
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
With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment.
Unresolved toxicities from prior antitumor therapy, defined as not having resolved to CTCAE, version 4.0 grade 1
Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment, with the exception of alopecia or neuropathy
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
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
Unresolved toxicities from prior antitumor therapy, defined as not having resolved to CTCAE, version 4.0 grade 1 (with the exception of myelosuppression, e.g., neutropenia, anemia, thrombocytopenia), or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior antitumor therapy that are considered irreversible (defined as having been present and stable for > 2 months) 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 sponsor
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
With the exception of alopecia, any unresolved toxicities from prior therapy ? Common Terminology Criteria for Adverse Events (CTCAE) grade 2
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
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
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 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 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
Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
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
Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy
208 Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to CTCAE version 4.0 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 the Amgen Medical Monitor.
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
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)
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
Except for alopecia, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study 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
Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v 4.03 < Grade 2 or normalized to baseline, or to levels dictated in the inclusion/exclusion criteria, with the exception of alopecia.
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
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
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)
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
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
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.
Unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) => Grade 2
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
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
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)
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
Has unresolved, clinically significant toxicities from prior anti-cancer therapy defined as > Grade 1 on Common Terminology Criteria for Adverse Events.
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
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.
With the exception of alopecia, any unresolved toxicities from prior chemotherapy should be no greater than CTCAE v4 grade 1 at the time of starting study treatment
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])
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
Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to CTCAE Grade 0 or 1, or to the levels dictated in the eligibility criteria with the exception of alopecia
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.
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
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
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
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
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
Recovery to baseline or =< grade 1 CTCAE v.4.0 from toxicities related to any prior treatments, unless adverse events (AEs) are clinically nonsignificant and/or stable on supportive therapy.
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
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
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
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
Recovery from non-hematologic toxicities of salvage cytoreductive chemotherapy to =< grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version 4 [v4])
Recovery from non-hematologic toxicities of salvage cytoreductive chemotherapy to =< grade 2 (Common Terminology Criteria for Adverse Events version 4 [CTCAE v4])
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
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
Recovery to baseline or ? Grade 1 CTCAE v4 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v]4) resulting from prior therapy must be =< grade 2
Nervous system disorders (Common Terminology Criteria for Adverse Events version 4 [CTCAE v4]) resulting from prior therapy must be =< grade 2
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
Patients with active >= Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4 grade 2 neuropathy are ineligible
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
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
Clinically active infection as judged by the site investigator (>= grade 2 by Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4)
History of high grade (Common Terminology Criteria for Adverse Events [CTCAE] >= grade 3) immune mediated adverse event from prior cancer immunotherapy
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
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
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])
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)
Proteinuria < Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or greater
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
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
Any immunotherapy-related adverse events Common Terminology Criteria for Adverse Events (CTCAE) > grade 1 at the time of registration
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 3-4 neuropathy
Proteinuria Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or greater
Bilirubin =< 1.5 times upper limit of normal (Common Terminology Criteria for Adverse Events [CTCAE] grade 1 baseline)
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
Persistence of any clinically relevant (Common Terminology Criteria for Adverse Events [CTCAE] grade 2 or above) toxicities from previous AML therapy
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)
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
Hepatic toxicity grade 2 (using Common Terminology Criteria for Adverse Events [CTCAE] version 4 standard definitions)
Baseline hearing deficit (Common Terminology Criteria for Adverse Events [CTCAE] version 4.0 grade 2 or higher)
Patients with unresolved diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 1
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
Participants with active diarrhea >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 despite medical management
Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade ?2 audiometric hearing loss
Active, ongoing toxicity (Common Terminology Criteria for Adverse Events [CTCAE] grade 2 or higher) from prior therapy
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
Participants with diarrhea >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Grade 3-4 electrolyte abnormalities (Common Terminology Criteria for Adverse Events [CTCAE], version [v.] 4):
Active, clinically serious infections > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Cholesterol < Common Terminology Criteria for Adverse Events (CTCAE) grade 3
Recovery from previous cancer treatment (=< grade 1 by Common Terminology Criteria for Adverse Events [CTCAE] 4.0 criteria) prior to first radiation treatment
Patient has >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety
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
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
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
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
Subject has cardiac disorders (Common Terminology Criteria for Adverse Events [CTCAE] version 4.03 Grade 3 or 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
Bilirubin greater than 1.5 x upper limit of normal (ULN) (Common Terminology Criteria for Adverse Events [CTCAE] v4.0 grade 1)
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)
Active Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 3 or higher viral, bacterial, or fungal infection
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
CTCAE (Common Terminology Criteria for Adverse Events) Grade ?2 bleeding disorder within 4 weeks before the start of anetumab ravtansine
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) version (v)4, grade 2 not controlled with antibiotics
History of grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4) or greater acute intracranial hemorrhage
Patient with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2; (CTCAE version 4.0)
Patient has >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 anxiety
No proteinuria Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or greater
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
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.
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
? Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 thrombocytopenia, OR
Participants with diarrhea > 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
Unresolved diarrhea >= Common Terminology Criteria for Adverse Events (CTCAE) version 4, grade 1
Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4) resulting from prior therapy must be < grade 2
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
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)
Any unresolved chronic toxicities > grade 2, measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4 (v4)
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
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 diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
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
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
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
Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Absolute neutrophil count (ANC) >= 1,500/mcl, equivalent to Common Terminology Criteria (CTCAE version [v] 4.03) grade 1
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
Anxiety ? Common Terminology Criteria (CTC) of adverse events (AE) grade 3.
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
Resolution of all transplant-related toxicity to =< grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) version (v.)4
toxicity attributed to previous anticancer therapy that did not resolve to Common Terminology Criteria for Adverse Events (CTCAE) grade =1
Skin rash Common Terminology Criteria for AEs (CTCAE) Grade greater than 1 from previous anti-EGFR therapy at time of randomization
Proteinuria by Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or greater
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
Documented hypersensitivity (Common Terminology Criteria for Adverse Events [CTCAE] grade >= 2) to any drug containing polysorbate 80
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
Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Proteinuria Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher.
Presence of peripheral edema > Grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version 4)
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
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
Diarrhea < grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version 4
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)
Have grade 1 or 2 symptomatic dry mouth (xerostomia) according to CTEP NCI Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
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)
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
CLINICAL SYMPTOMS (EACH AT LEAST GRADE 1 BY COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS [CTCAE] DEFINITIONS)
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
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
Persistent toxicities (>= Common Terminology Criteria for Adverse Events [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia and CTCAE grade 2 peripheral neuropathy
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
Persistent toxicities (>= Common Terminology Criteria for Adverse Events [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia
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
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
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
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
Patients with persistent toxicities (>= Common Terminology Criteria for Adverse Events [CTCAE] grade 2) with the exception of alopecia, caused by previous cancer therapy
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
Persistent toxicities (>= common terminology criteria for adverse events grade 2) with the exception of alopecia, caused by previous cancer therapy.
All prior treatment-related toxicities must be CTCAE (version 4.03) =< grade 1 (except alopecia) at the time of randomization
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)
Previous treatment-associated clinically significant toxicities resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade =< 1 (except alopecia) or baseline
Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia
Persistent toxicities (>= Common Terminology Criteria for Adverse Events [CTCAE] grade 2), with the exception of alopecia, caused by previous cancer therapy
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
Previous treatment-associated toxicities resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade =< 2 (except alopecia)
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
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
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
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
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
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
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
Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia
Persistent toxicities (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia.
All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) =< grade 1 (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.
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 chemotherapy related toxicities from prior treatment (> grade 2 per Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0)
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
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
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
Toxicities (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2) caused by previous cancer therapy
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.
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).
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
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
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
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.
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
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
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
Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia.
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
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
Any chemotherapy related toxicities from prior treatment (>= grade I per Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0)
Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia;
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
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).
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
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.
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
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
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
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
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.
Patients must not have any unresolved toxicity greater than National Cancer Institute (NCI)-CTCAE version (v) 4.0 grade 1 from previous anti-cancer therapy except alopecia within 7 days prior to registration
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
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).
Unresolved toxicity higher than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 attributed to any prior therapy or procedure, excluding alopecia
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
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 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)
Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2) from previous anti-cancer therapy
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
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
Any unresolved toxicity >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 from previous anti-cancer therapy, except for alopecia and neurotoxicity
Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2) from previous anti-cancer therapy
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)
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)
Any unresolved toxicity Common Terminology Criteria for Adverse Events (CTCAE) > grade 2 from previous anti-cancer therapy
Unresolved toxicity > Common Terminology Criteria for Adverse Events (CTCAE) grade 2 from previous anti-cancer therapy, except for alopecia
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 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
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
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
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
Any unresolved toxicity Grade 2 or more according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) from previous anticancer therapy
Any unresolved toxicity CTCAE (Common Terminology Criteria of Adverse Events) >Grade 2 from previous anti-cancer therapy
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.
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
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.
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;
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
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.
Unresolved toxicity of Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater from previous anti-cancer therapy or radiotherapy
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)
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
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.
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.
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).
Any unresolved chronic toxicity with Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2, from previous anti-NF1 therapy, except for alopecia
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 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)
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
Resolution of all acute adverse events resulting from prior cancer therapies to NCI CTCAE grade ? 1 or baseline
Patients who have not recovered to < Common Terminology Criteria for Adverse Events (CTCAE) grade 2 toxicities related to prior therapy are ineligible
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).
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
Chemotherapy, radiotherapy, and/or biological cancer therapy within 3 weeks prior to the first trial dose or has not recovered to CTCAE v.4 grade 1 or better from adverse events (except alopecia).
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
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 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.
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
Prohibited anti-NSCLC therapies and not having recovered from related AEs to Common Terminology Criteria for Adverse Events (CTCAE) Grade ?1
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
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).
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
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
Fully recovered from acute toxicities (except alopecia) of all prior therapies to Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1
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.
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
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
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)
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
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
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
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 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
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
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.
Part 1 patients who have not recovered to < Common Terminology Criteria for Adverse Events (CTCAE) grade 2 toxicities related to prior therapy are ineligible
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)
Patients who have not recovered to < Common Terminology Criteria for Adverse Events (CTCAE) grade 2 toxicities related to prior therapy are ineligible
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
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
PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have recovered from any adverse effects from prior therapy (except alopecia) to =< CTCAE grade 1 prior to registration
Patients who have received systemic cytotoxic chemotherapy, immunotherapy for 3 weeks before initiation of planned WBRT or patients who have not recovered from serious (Common Terminology Criteria for Adverse Events [CTCAE] grade 3 or more) adverse events from the previously received agents; for oral targeted agents or any other investigational agents, at least 4 half-lives of the agent (6 weeks for nitrosoureas or mitomycin C) should have elapsed prior to starting study treatment
Resolution of all acute adverse events resulting from prior cancer therapies to NCI CTCAE grade ? 1 or baseline (except alopecia or neuropathy)
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 adverse events resulting from prior cancer therapies to NCI CTCAE grade ? 1 or baseline (except 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
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.
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).
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
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])
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)
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
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
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)
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
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
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
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).
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.
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
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)
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 adverse events resulting from prior cancer therapies to NCI CTCAE grade ? 1 or baseline
Dehydration grade >= 1 NCI-CTCAE v4.0
Dehydration ? grade 1
Dehydration grade >= 1 NCI-CTCAE v4.0
Dehydration grade >= 1 NCI-CTCAE v4.0
Dehydration grade >= 1 NCI-CTCAE v4.0
Dehydration grade >= 1 NCI-CTCAE v4.0
Dehydration grade >= 1
Dehydration Grade ? 1 NCI-CTCAE v4.03.
Dehydration grade >= 1 NCI-CTCAE v4.0
Dehydration CTCAE (version 4.0) grade >= 1
Dehydration according to NCI-Common Toxicity Criteria (CTC) v 4.0 grade >= 1
Dehydration Grade > 2 NCI CTCAE v4 within 7 days prior to registration.
Dehydration NCI-CTCAEversion 4.0 Grade ? 1
Dehydration > grade 1
No conditions that would be exacerbated by dehydration in the opinion of the investigator
Dehydration grade > 1 NCI-CTCAE v4.0