Residual CTCAE ? Grade 2 toxicity from any prior anticancer therapy, with the exception of Grade 2 alopecia or Grade 2 neuropathy
Prior to randomization patients with any non-hematologic toxicity from surgery, chemotherapy, or radiation must have recovered to grade =< 1 with the exception of alopecia and the criteria outlined
Patients must have recovered to =< grade 2 following a significant adverse event or toxicity attributed to previous anti-cancer treatment except neurotoxicity which must be =< grade 1
Prior to randomization patients with any non-hematologic toxicity from surgery, chemotherapy and radiation therapy must have recovered to grade =< 1 with the exception of alopecia, ototoxicity and neuropathy
CNS toxicity =< grade 2
Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 (except hemoglobin value) and/or that is progressing in severity, except alopecia
Resolution of toxicity from prior anti-cancer therapy, to NCI CTCAE v4.03 Grade 0 or 1, except for alopecia. Subjects may be enrolled if their toxicity is determined to be irreversible and will not put them at undue risk from study treatment, based on the Investigator's assessment.
CNS toxicity =< grade 2
At least two weeks from last systemic therapy for breast cancer, with recovery of all treatment related toxicity to grade 1 or less; subjects with =< grade 2 neuropathy are an exception to this criterion
Presence of ? CTCAE Grade 2 toxicity due to prior cancer therapy.
Participants who have not recovered to =< 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)
CTCAE Version 4, Grade 4 non-hematological toxicity (except for alopecia, nausea, vomiting).
Grade > 2 toxicity (other than alopecia) continuing from prior anti-cancer therapy
Grade >= 2 toxicity (other than alopecia) continuing from prior anti-cancer therapy
Subjects with known persistent (> 4 weeks) >= grade 2 toxicity from prior cancer therapy
Patients with grade > 1 neuropathy or grade > 1 toxicity (except alopecia or anorexia) from prior therapy
Grade > 1 toxicity from prior therapy (except alopecia or anorexia)
Grade 3 or higher toxicity effects from previous treatment with immunotherapy
Patients with history of any grade 4 toxicity during previous anti PD-1 treatment or history of grade 3 or higher pneumonitis
Must have discontinued radiotherapy at least 14 days with resolution of any toxicity to Grade 1 or better prior to the start of treatment.
Grade >= 2 toxicity (other than alopecia) continuing from prior anticancer therapy, including radiation
Neuropathy as residual toxicity after prior antitumor therapy Grade >2
Patients who experienced grade 3 or above skin toxicity from prior EGFR inhibiting therapy
Patients who have experienced grade 3 or above toxicity from prior anti-PD1 therapy
Residual or ongoing ? Grade 3 toxicity from chemotherapy
have inadequate recovery* from adverse events resulting from previously-administered anti-cancer therapies; [*Note: Unless more specifically defined in Inclusion Criteria 6, 7 and 8 above, adequate recovery is defined as improvement to ? Grade 2 for any other hematologic toxicity and for peripheral neuropathy, and improvement to ? Grade 1 for any other non-hematologic toxicity.]
Recovered from any prior treatment related toxicity to at least Grade 1 with exception of Grade 2 alopecia or other Grade 2 toxicity with prior approval of the Medical Monitor
Subjects with history of grade 3 toxicity or use of infliximab with prior immunotherapy
Presence of grade 3 or greater toxicity from the previous treatment.
Ongoing clinically significant toxicity (Grade 2 or greater) associated with prior treatment (including radiotherapy or surgery).
At least 4 weeks (wks) since prior radiation or surgery with full recovery (no persistent toxicity >= grade 1)
Hydroxyurea may be used to control leukocytosis, provided that it is without grade > 2 toxicity, and can be taken until start of therapy
Ongoing acute treatment-related toxicity associated with a previous therapy greater than grade 1 except for grade 2 alopecia or neuropathy.
To be eligible for study treatment, toxicity from prior treatment must recover to Grade ? 1, except for alopecia
Has experienced grade 4 toxicity on treatment with prior radiation
Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for alopecia);
At least 4 weeks from end of surgery, chemotherapy, or radiotherapy with resolution of any toxicity to grade 1 or less, excluding alopecia\r\n* NOTE: There is no washout for patients who have undergone cosmetic surgeries
At least 14 days from the last therapy dose or 5 half-lives (whichever is shorter), and resolution of toxicity related to the last therapy, excluding grade 2 or less peripheral neuropathy and alopecia; for radiation therapy, a minimum of 2 weeks and resolution of all acute toxicity will be required
To be eligible for study treatment, toxicity from prior treatment must recover to Grade ? 1, except for alopecia
Patients who have residual toxicity(-ities) from previous anti-cancer treatment(s) that is/are clinically significant or > grade 1 are excluded; those whose toxicity(-ities) improved to grade 1 or better will be eligible
Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity (except alopecia); any immuno-oncology (IO) related adverse events must be =< grade 1 to be eligible
Any clinically significant toxicity from prior therapy must have improved to grade 0 or grade 1
Skin toxicity no greater than grade 1
Prior grade 4 toxicity attributed to cytarabine
Existing severe major organ dysfunction, i.e., renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity >= grade 3, except for grade 3 hematologic toxicity
At least 4 weeks since prior surgery with full recovery (no persistent toxicity >= grade 1)
Patient who has had radiotherapy within 1 week (or unresolved radiation-related toxicities), chemotherapy within 2 weeks or 5 half-lives, whichever is longer (6 weeks for nitrosoureas, mitomycin C or bevacizumab), anti-cancer monoclonal antibody for direct anti-neoplastic treatment within 3 weeks, or who has not recovered from toxicity due to previous agents administered. If the patient has residual toxicity from prior treatment, toxicity must be =< grade 1 (except for neuropathy and alopecia)
Any previous history of >= grade 3 toxicity to dasatinib
If the patient has residual toxicity from prior treatment, toxicity must be =< grade 1
Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity, except alopecia
Recovery to Grade 1 of any clinically significant toxicity attributed to prior anticancer therapy prior to initiation of study drug administration
Severe major organ toxicity: specifically, renal, cardiac, hepatic, pulmonary, gastrointestinal and neurologic toxicity should all be grade 2 or less; a grade 3 hearing deficit is acceptable
Otherwise, all toxicity at study entry ? Grade 1 by NCI CTC v4.0.
Grade > 1 toxicity from prior therapy (except alopecia or anorexia)
Has persistent, clinically significant > Grade 1 non-hematologic toxicity from prior AML therapies
Grade > 1 toxicity from prior therapy (except alopecia or anorexia).
Patients will be ineligible if they have a baseline neurologic toxicity of grade 3 or greater
Skin toxicity =< grade 1
Grade 2 or greater toxicity from prior therapy
Patients who have a CNS toxicity > grade 2 are not eligible
Omission of cytotoxic chemotherapy or other systemic therapy of the malignancy for >= 4 weeks prior to entry into the trial; patients must be >= 4 weeks since major surgery, radiotherapy, or biotherapy/targeted therapies and recovered from the toxicity of prior treatment to =< Common Toxicity Criteria (CTC) grade 1, exclusive of grade 2 alopecia, fatigue, lymphopenia, CD4+ circulating T cells, white blood count (WBC) or bilirubin
Resolution of grade >= 2 toxicity from prior therapy (other than alopecia)
Persistent, clinically significant > Grade 1 non-hematologic toxicity from prior AML therapy.
Any ongoing toxicity from prior anti-cancer therapy that is greater than grade 1 and/or that is progressing in severity, except alopecia
Patients must not have any known, persistent (> 4 weeks), ?Grade 3 hematologic toxicity during the last cancer therapy. Patients must not have any known, persistent (>4 weeks), ? Grade 3 fatigue during the last cancer therapy.
Current grade >= 1 toxicity (except alopecia) from prior therapy
Failure to recover (to CTCAE Version 4.0 Grade 0 or Grade 1) from acute non hematologic toxicity (except all grades of alopecia or Grade 2 or lower neuropathy), due to previous therapy, prior to Screening.
Subjects who have not recovered to within one grade level (not to exceed grade 2) of their baseline following a significant adverse event or toxicity attributed to prior anti-cancer treatment are excluded
Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity (except alopecia)
Ongoing toxicity due to a prior therapy, unless returned to baseline or Grade 1. Grade 2 toxicities (e.g., alopecia or peripheral neuropathy) that are not likely to increase the subject's safety risk while receiving trial treatment may be accepted after Sponsor approval.
Minimal or no ongoing toxicity from immediately prior therapy according to specific appropriate criteria. Mild ongoing toxicity is allowed in case of alopecia, skin toxicity, fatigue and/or finger numbness or tumbling.
No neurosensory or neuromotor toxicity >= grade 2 at the time of registration
Grade >1 toxicity from prior therapy (except alopecia or anorexia).
Current Grade greater than (>) 1 toxicity (except alopecia and anorexia) from prior therapy
Lack of recovery from all toxicity from previous therapy to grade 1 or baseline
Uncontrolled grade 2 or greater toxicity except alopecia
Presence of grade 3 or greater toxicity from the previous treatment
known and persistent (>4 weeks) >/= grade 3 toxicity or fatigue from prior cancer treatment.
Toxicity of ? Grade 2 from prior anticancer therapy
Patients must be at least 2 weeks from prior chemotherapy, including biologics or targeted therapy (i.e. everolimus), or radiotherapy, or any investigational drug product, with adequate recovery of toxicity to baseline, or grade < 1, with the exception of alopecia and hot flashes; there is no washout period for prior endocrine therapy
Grade > 2 toxicity (other than alopecia) continuing from prior anti-cancer therapy
Grade ? 2 toxicity (other than alopecia).
Patients with > grade 1 neurologic toxicity at the time of treatment
Patients will be ineligible if they have a baseline neurologic toxicity of grade 3 or greater
Grade ? 2 toxicity (other than alopecia) continuing from prior anticancer therapy including radiation.
Any ongoing toxicity related to prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity (exceptions include alopecia, fatigue, and hematologic toxicities)
Any systemic therapy associated toxicity should be grade 1 or less
Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity, except alopecia
Any ongoing toxicity from prior hormonal therapy that is > grade 1 and/or that is progressing in severity
Residual toxicity resulting from previous therapy (for example, hematologic, cardiovascular, or neurologic toxicity that is Grade >/=2). Alopecia is permitted
Completed > 80% of the prescribed radiation therapy and concurrent temozolomide according to the Stupp regimen without grade 3 or 4 hematologic toxicity
Patient must not be experiencing any ongoing toxicity from prior anti-cancer therapy that is > grade 1 or that is progressing in severity, except alopecia
Any previous history of >= grade 3 toxicity to Dasatinib
Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity, except alopecia
Any history of previous >= grade 3 toxicity attributable to erlotinib (except dermatological toxicity)
Patients must be at least 2 weeks from prior chemotherapy or radiotherapy, or any investigational drug product with adequate recovery of toxicity to baseline, or grade =< 1, with the exception of alopecia and hot flashes; there is no washout period for prior endocrine therapy
Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity
Any ongoing toxicity from prior investigational therapy that is > grade 1 and/or that is progressing in severity, except alopecia
Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity, except alopecia
EXPANSION COHORT ONLY: Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity; hypothyroidism treated with medication is not excluded if TSH is within normal limits
Any unrecovered toxicity reactions of CTCAE version 4.03 > grade 1 caused by any previous therapy (excluding alopecia and neurotoxicity < grade 2)
PRIOR TO MOBILIZATION THERAPY: Resolution of grade III-IV toxicity associated with pre-transplant therapy
Failure to recover to Grade 0 or Grade 1 from acute non-hematologic toxicity due to previous therapy, prior to screening (with the exception of alopecia).
Persistence of toxicity from previous chemo and/or radiotherapy > grade 2
Patients who have toxicity from last prior therapy that has not recovered to at least Grade 1, with the exception of Grade 2 alopecia
Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity, except alopecia.
Current Grade greater than (>) 1 toxicity (except alopecia and anorexia) from prior therapy or Grade >1 neuropathy from any cause
Participant with ? Grade 2 (CTCAE v 4.0-JCOG) persistent symptoms and objective findings due to the toxicity attributable to prior treatment with antitumor effect (except alopecia).
Lack of recovery from all toxicity from previous therapy to grade 1 or baseline
Patients with chronic grade 1 or 2 toxicity may be eligible at the discretion of the principal investigator if the condition has been stable, and not worsening, for at least 30 days; patients with ongoing alopecia of any grade will be eligible
Toxicity (except alopecia and anorexia) from prior therapy or neuropathy of grades >
Prior clinically significant grade 3-4 non-hematological toxicity to high dose Ara-C or grade ? 2 of neurological toxicity.
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study; if the patient has residual toxicity from prior treatment, toxicity must be =< grade 1 (or =< grade 2 for peripheral neuropathy and/or alopecia)
Residual toxicity of > grade 1 from prior therapy
Must not be experiencing a Grade 3 or 4 toxicity from previous anti-cancer treatment
Current Grade >/= 2 toxicity (except for alopecia, anorexia and fatigue) from prior therapy or Grade >/= 2 neuropathy
Adequate recovery (to at least Grade 1) from toxicity of prior therapy as follows:
Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity, except alopecia.
Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity
Any on-going toxicity from prior anti cancer therapy except alopecia;
At least a 2-week recovery from prior therapy toxicity.
Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity, except alopecia
Reduction of any acute toxicity from radiation treatment to grade 1
Have unresolved toxicity from prior radiation, chemotherapy, or other targeted treatment, including investigational treatment, with the exception of alopecia and ?Grade 1 peripheral neuropathy according to the NCI CTCAE v4.03. Clinical judgment by the investigator is allowed to determine if Grade 1 fatigue at screening is residual toxicity from prior treatment or is a symptom of the patient's general condition or disease. The investigator and Medical Monitor will discuss the eligibility of patients with baseline toxicity.
Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade less than or equal to (</=) 1 prior to study entry, with the exception of alopecia
Grade > 2 toxicity (other than alopecia) continuing from prior anti-cancer therapy
PHASE I: Cardiac, pulmonary, gastrointestinal and neurologic toxicity should all be =< grade 2
Major organ toxicity including cardiac, pulmonary, gastrointestinal and neurologic toxicity more than grade 2
Patient must not have any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is progressing in severity, except alopecia
Residual toxicity due to previous anticancer therapy with no return to baseline or =< Grade 1 (except alopecia) according to CTCAE V4.03
Resolution of treatment-related toxicity to < grade 1; alopecia and cutaneous toxicity are allowed < grade 2
grade 3 to 4 nonhematologic toxicity that does not resolve with adequate intervention
grade 4 hematologic toxicity lasting more than 7 days, or a documented inability to sustain the TKI therapy because of recurrent grade 3 or 4 hematologic toxicity with re-initiation of the same therapy
any grade 2 or greater toxicity that is unacceptable to the patient
Failure to recover from Grade 3 or 4 toxicity from previous treatment
Failure to recover from acute non hematologic toxicity (except alopecia or Grade 2 or lower neuropathy), due to previous therapy, prior to Screening.
Patients must have recovered from adverse events (toxicities resolved to grade 1 or less) of prior therapy; patients with immune related toxicities from ipilimumab + nivolumab may continue onto Step 2 even if still on steroids to control side effects, so long as toxicity has resolved to grade 1 or less
All non-hematologic treatment related toxicities that are deemed clinically significant by the treating investigator must have resolved to =< grade 2
Registration Step 3 – Maintenance: All non-hematologic treatment related toxicities that are deemed clinically significant by the treating investigator must have resolved to =< grade 2
Treatment with chemotherapy or investigational drugs within 21 days prior to the screening visit. Acute toxicities from prior therapy must have resolved to Grade ? 1 above baseline.
Adverse events from prior anti-cancer therapy resolved to Grade < or = 1, except any grade alopecia and/or peripheral sensory or motor neuropathy which must have resolved to Grade < or = 2
All ACT related toxicities resolved to grade 1 with the exception of alopecia, vitiligo and endocrine abnormalities requiring replacement therapy which may be grade 2
Major surgery or treatment with any chemotherapy, radiation therapy, biologics for cancer or investigational therapy in the 28 days before the first dose of study treatment (subjects with prior cytotoxic or investigational products <3 weeks prior to study treatment might be eligible after discussion between the Investigator and Medical Monitor, if toxicities from the prior treatment have been resolved to NCI CTCAE Grade 1). All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to Grade 1 or baseline before the first dose of study treatment. 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 enrol
Acute toxicities from any prior anti-tumor therapy, surgery, or radiotherapy that has not resolved to Grade </=2, except alopecia
Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade 0 or 1 as per the NCI-CTCAE v 4.03.
All toxicities (except alopecia) from prior cancer treatments must have resolved to ? Grade 1 or returned to baseline levels prior to enrollment
Patients currently receiving other anti-melanoma treatment; toxicities attributable to any prior therapy must have resolved to grade 1 or better prior to enrollment
Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
All anticancer- and radiation therapy-related toxicities must be completely resolved or downgraded to Grade 1 or less (neuropathy may be Grade 2 or less).
Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
All non-hematological toxicity of previous cancer therapy should have resolved to =< grade 1 (except alopecia or other toxicities not involving major organs)
Prior treatment-related toxicities that have not resolved to ? Grade 1 before the date of study drug administration except for stable chronic toxicities (? Grade 2) not expected to resolve (eg, stable Grade 2 peripheral neurotoxicity).
Has significant toxicities from prior treatment that have not resolved or stabilized
All prior treatment-related toxicities resolved to =< grade 1 or are determined to be clinically stable by the investigator
Has clinically significant toxicities from previous anti-cancer therapy that have not resolved, or have not stabilized at a new baseline
For participants entering cohorts C or D, prior treatment-related toxicities should have resolved to grade 1 or baseline (with the exception of anemia (as per inclusion criteria, alopecia, and neuropathy [=< grade 2 allowed])
Prior radiation or surgery must have completed at least 2 weeks prior to initiation of therapy and all toxicities or complications from these must have resolved to baseline or grade 1 prior to starting therapy (with the exception of anemia (as per inclusion criteria, alopecia, and neuropathy [=< grade 2 allowed])
Should be off any active therapy for AML with the exception of hydroxyurea for at least 14 days prior to study registration unless patient has rapidly progressive disease, and all grade 2-4 non-hematologic toxicities should have resolved
All acute treatment-related toxicities from prior therapy must have resolved to grade =< 1 prior to study entry excluding alopecia
Toxicities from previous cancer therapies resolved to =< grade 1 unless specified otherwise in the inclusion or exclusion criteria (Exceptions: Chronic residual toxicities that in the opinion of the investigator are not clinically relevant given the known safety/toxicity profiles of pemetrexed and sorafenib, such as alopecia, changes in pigmentation, stable endocrinopathies; neuropathy related to previous chemotherapy must be resolved to =< grade 2)
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nToxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per CTCAE v 4.03 except hemoglobin; patients with long-standing stable grade 2 neuropathy may be considered after discussion with the PI
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nToxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per CTCAE v 4.03 except hemoglobin; patients with long-standing stable grade 2 neuropathy may be considered after discussion with the PI
Non-hematologic toxicities from previous cancer therapies resolved to =< grade 1 except chronic residual toxicities that in the opinion of the investigator are not clinically relevant given the known safety/toxicity profiles of regorafenib and sildenafil (eg, alopecia, changes in pigmentation, stable endocrinopathies)
Treatment-related toxicities from prior therapies must have resolved to grade =< 1
Treatment-related toxicities from prior therapies must have resolved to grade equal to or less than 1
All acute toxicities from prior therapy with the exception of alopecia must have resolved to =< grade 1
Toxicities from previous anti-cancer therapies have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy
Treatment with chemotherapy or investigational drugs within 21 days prior to the screening visit. Acute toxicities from prior therapy must have resolved to Grade ? 1 above baseline.
Toxicities incurred as a result of previous anti cancer therapy (radiation therapy [RT], chemotherapy, or surgery) must be resolved to ? Grade 1 except for alopecia and anorexia.
Non-hematologic toxicities from previous cancer therapies resolved to =< grade 1
Previous toxicities from previous treatment must have resolved to grade 1 or less\r\n* For patients in expansion cohort B, stable grade 2 neuropathy will be allowed
Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per CTCAE v 4.0
Cytotoxic chemotherapy or radiotherapy within 3 weeks prior and any encountered treatment-related toxicities (excepting alopecia) not resolved to Grade 1 or less [Phase 1] or Grade 2 or less [Phase 2].
Monoclonal antibodies within 4 weeks prior and any encountered treatment-related toxicities not resolved to Grade 1 or less [Phase 1] or Grade 2 or less [Phase 2].
Investigational drugs (small molecules or biologics) within the longer of 2 weeks or 5 half-lives prior to study treatment and any encountered treatment-related toxicities not resolved to Grade 1 or less [Phase 1] or Grade 2 or less [Phase 2].
Toxicities due to prior cancer therapy that have not resolved before the initiation of study treatment, if the Investigator determines that the continuing complication will compromise the safe treatment of the patient
Acute toxicities of prior treatments and procedures not resolved to grade ? 1 or baseline before randomisation.
Patients must have recovered (to baseline/stabilization) from prior chemo- or radio-therapy and associated acute toxicities must have resolved to a NCI CTCAE v4 Grade 1 or less, with the exception of alopecia
Toxicities related to biopsy must have resolved prior to proceeding with radiation therapy.
All treatment-related or radiation-related toxicities resolved to Grade 1 or lower
Should be off any active systemic therapy for AML with the exception of hydroxyurea for at least 14 days prior to study registration unless patient has rapidly progressive disease, and all grade 2-4 non-hematologic toxicities should have resolved
Persistent clinically significant toxicities (Grade ?2) from previous anticancer therapy (excluding Grade 2 chemotherapy-related neuropathy and alopecia which are permitted). Prior toxicities that resulted in laboratory abnormalities should have resolved to Grade ?1. If medical therapy is required for the treatment of a laboratory abnormality, the dose and laboratory value(s) should be stable.
All grade >= 2 toxicities other than alopecia from prior therapy have resolved by the time of study commencement
Toxicities from prior therapies that have not resolved to grade 1 or grade 0
ELIGIBILITY FOR TREATMENT ON ARM 1: Patients treated with prior immunotherapy including and not limited to vaccines, cytokines, T cell stimulating agents, cytotoxic T lymphocyte antigen 4 (CTLA4) inhibitors and programmed death (PD)-1 check point inhibitors are allowed on therapy provided they did not have any severe grade 4 toxicities due to prior therapy and any toxicities due to prior therapy should have resolved, if resolvable to less than or equal to grade 1
Any Grade 3 or 4 toxicities (according to NCI CTCAE) resolved for at least 2 weeks prior to first treatment
PART B: Previous treatment related side-effects/adverse events must have resolved to at least grade 1 or, at the discretion of the investigator, select stable grade 2 toxicities (e.g. alopecia or fatigue) may be permissible if unchanging in grade for at least 3 months following discussion with the principal investigator (PI)
Prior adjuvant therapy for CRC including fluoropyrimidines either alone or in combination with oxaliplatin is allowed, provided that all therapy was completed >= 12 months from cancer recurrence, therapy duration was =< 6 months, and all prior toxicities have completely resolved (residual grade 1 neuropathy is allowed)
Prior radiation to sites other than the brain is allowed, if completed at least 2 weeks before treatment and provided that all radiation-related toxicities have resolved to =< grade 1
Unresolved toxicities from prior therapy with the exception of alopecia that have not resolved to ? Grade 1 at the time of starting study treatment
Patients are permitted to have been treated with previous systemic chemotherapy; a minimal time interval since last dose of cytotoxic chemotherapy must be equal to or greater than 21 days, and all acute toxicities should be resolved to less than grade 2, and hematologic counts should meet study criteria; with regards to toxicity, patients who have left sided chest wall recurrences should not have previously exceeded more than 450 mg/m^2 doxorubicin due to expected cumulative cardiotoxicity; prior taxane therapy is allowed, however, there should be no reported anaphylactic reactions of grade 3 or higher
9. All prior cytotoxic toxicities must have resolved to grade ? 1 prior to randomization.
Has unresolved toxicities from prior anti-cancer therapies, defined as toxicities (chemotherapy, hormonal treatment, radiation, and/or surgery) not yet resolved to NCI-CTCAE, v4, Grade <= 1 or baseline; other than alopecia, skin toxicity (Grade 1), according to NCI-CTCAE, v4. Subjects with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator and Sponsor (e.g., Grade 2 chemotherapy-induced peripheral neuropathy).
Should be off any active therapy for AML with the exception of hydroxyurea for at least 14 days prior to study registration unless patient has rapidly progressive disease, and all grade 2-4 non-hematologic toxicities should have resolved
Clinically significant toxicities from prior chemotherapy must be resolved to Grade ?
Prior chemotherapy or surgery must have been completed at least 28 days prior to registration, and all toxicities must have resolved
No limit to prior therapies with last anti-cancer treatment >= 2 weeks from initiation of protocol-based therapy provided all toxicities (other than alopecia) have resolved to =< grade 1 or baseline
All acute toxicities related to prior therapy must have resolved prior to study entry, except for alopecia and mild neuropathy
All prior treatment related non-hematologic toxicities (with the exception of alopecia) must have resolved to CTCAE (Version 4.0) ? Grade 2 at the time of randomization.
All previous therapy-related toxicities must have resolved or return to baseline.
All previous treatment (including surgery, radiotherapy and systemic anti-neoplastic therapy) must have been completed at least three weeks prior to study entry and any acute toxicities must have resolved
Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ? 1 or baseline. Subjects with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator after consultation with the Sponsor Medical Monitor or designee (eg, Grade 2 chemotherapy-induced neuropathy).
Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
>= 21 days must have elapsed from infusion of lase dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
>= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
Participant has not adequately recovered from toxicity of previous therapy
Participants must have recovered from any acute toxicity associated with prior therapy
Previous imatinib treatment should be permanently discontinued within 4 days prior randomisation and patient should have recovered from potential toxicity related to imatinib
Patients must have recovered to eligibility levels from prior toxicity or adverse events as a result of previous treatment prior to entering the study (except alopecia).
Patient must have recovered to Grade 1 toxicity from prior cancer therapy
Participants must have recovered to eligibility levels from prior toxicity or adverse events as a result of previous treatment prior to entering the study
Any anti-cancer treatment (except for radiation therapy) within 21 days, or any investigational agent within 30 days prior to the first dose of study drug; participants should have recovered from any toxicity related to previous anti-cancer treatment to Common Toxicity Criteria (CTC) grade 0 or 1.
Patients may have received prior radiation, chemoembolization, radioembolization or other local ablative therapies or hepatic resection if completed >= 4 weeks prior to registration AND if patient has recovered to =< grade 1 toxicity
Must have completely recovered or recovered to baseline prior to screening from any prior AEs occurring while receiving prior immunotherapy.
There are no limits on prior lines of therapy; however, patients must have recovered to eligibility levels from prior toxicity or adverse events as a result of previous treatment prior to entering the study (except alopecia)
> = 21 days must have elapsed from infusion of last dose of antibody and toxicity related to prior antibody therapy must have recovered to Grade <= 1.
Participants who have not recovered to eligibility levels from prior toxicity or adverse events as a result of previous treatment prior to the study.
Radiation therapy =< 2 weeks prior to study entry; patients who have received prior radiotherapy must have recovered from toxicity (=< grade 1) induced by this treatment (except for alopecia)
Subject has tolerated prior dose of modified CAR T cell infusion without experiencing a severe toxicity; OR if patient did have a severe toxicity, they have fully recovered to baseline
Recovered from any toxicity to grade 2 or less from all prior chemotherapy, immunotherapy or radiotherapy and be at least 30 days past the date of their last treatment with the exception of mitotane which may be continued
Patients on every 2, 3 or 4 week systemic therapy programs must be off the treatment program for at least 2, 3, or 4 weeks, respectively, and must have recovered from any clinically significant toxicity experienced; patients on weekly or daily systemic therapy programs and patients receiving radiation must be at least 1 week since treatment and recovered from any clinically significant toxicity experienced; must be at least 4 weeks and have recovered from major surgery
Patient must have completed prior chemotherapy at least 2 weeks (washout period) prior to randomization and recovered from toxicity to Grade 1 or baseline
Patients must have recovered from the toxic effects of prior therapy to < grade 2 toxicity per Common Toxicity Criteria (CTC) version 4 (except deep vein thrombosis)
Patients must have recovered from toxicity of prior therapy
Any toxicity from prior therapy must have recovered to ? Grade 1 (except alopecia).
Prior chemotherapy provided patients have been off previous anti-cancer therapy for at least 21 days and recovered from all treatment related toxicity
Patients must be at least 4 weeks from any prior treatments and have recovered (to < grade 2) from acute toxicity attributed to this prior treatment, unless considered chronic
Patients must have recovered from acute non hematologic toxicity (to =< grade 1) of all previous therapy prior to enrollment
There is no restriction on the number of prior therapies allowed for this disease and prior radiation and chemotherapy is allowed, provided the subject has recovered from all grade 2 or greater toxicity prior to enrollment
No chemotherapy or radiotherapy within the past 28 days and patients must have recovered any acute toxicity associated with their most recent previous treatment
Not recovered from toxicity of any prior chemotherapy to grade ? 1.
Patients who have not recovered from acute non hematologic toxicity (to =< grade 1) of all previous therapy prior to enrollment
Recovered from toxicity of previous chemotherapy (excludes grade 1 neurotoxicity and hematological toxicity)
Patients must be recovered from any toxicity from all prior chemotherapy, immunotherapy, or radiotherapy and be at least 14 days past the date of their last treatment
Fully recovered from toxicity due to prior therapy
Otherwise, all acute toxicity at study entry ? Grade 1 by NCI CTC v4.0, or recovered to baseline
Patients must be recovered from any toxicity from all prior chemotherapy, immunotherapy, or radiotherapy and be at least 14 days past the date of their last treatment
Patients must have recovered from toxicity of prior therapy
Subjects must have recovered from all toxicity associated with previous chemotherapy,\n             targeted therapy, or radiotherapy
Prior local radiation therapy must be completed at least 30 days prior to enrollment and the patient must have recovered from all toxicity
Patients who have had chemotherapy, targeted therapy, or radiotherapy, and have not recovered from acute toxicity to their pretreatment baseline or to a grade 1 level within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study \r\n* Note: patients with chronic residual prior therapy-related toxicity (e.g. vitiligo, alopecia, low grade neuropathy), or in the consensus opinion of the Cancer Immunotherapy Trials Network (CITN)/Cancer Therapy Evaluation Program (CTEP) investigators would not impact the safety of the patient or the integrity of the study, are not excluded\r\n* Note: for resolution of autoimmune toxicity from prior immune therapy, patients must be off steroids for at least 30 days without relapse of autoimmune toxicity, or it must be at least 30 days from their last dose of infliximab or related immunosuppressive therapy without relapse of autoimmune toxicity
Patients on every 2, 3, or 4 week systemic treatment programs must be off the treatment program at least 2, 3, or 4 week, respectively, and must have recovered from any clinically significant toxicity experienced; patients on weekly or daily systemic treatment programs and patients receiving radiation must be off at least 1 week and must have recovered from any clinically significant toxicity experienced; must be at least 4 weeks and have recovered from major surgery
Patients must have recovered from any VEGF blocking drug-related toxicity (proteinuria, hypertension, hepatotoxicity, and pancreatic toxicity)
Recovered from any toxicity to grade 2 or less from all prior chemotherapy, immunotherapy or radiotherapy and be at least 30 days past the date of their last treatment with the exception of mitotane which may be continued
Prior chemoembolization, local ablative therapies, or hepatic resection permitted if completed >= 4 weeks prior to study enrollment if patient has recovered with =< grade 1 toxicity and if measurable disease is present
Have recovered from any acute toxicity related to prior therapy.
Patients must have recovered from any acute toxicity associated with prior therapy by the start of study treatment
Patients should have discontinued any and all other therapy for CLL >= 48 hours prior to start of study therapy and recovered from any toxicity due to these therapies to grade =< 1
Participants must have recovered to grade 1 toxicity from prior therapy
Patients must have recovered from toxicity of prior therapy
Patients must have recovered from the toxicity of prior therapy to less than grade 2
Patients may have been treated with locoregional therapies such as major surgery, radiation, radiofrequency ablation, or cryosurgery provided this has been completed at least 4 weeks prior to registration and recovered from therapy related toxicity to less than CTCAE grade 2
Patients must be recovered from any toxicity from all prior chemotherapy, immunotherapy, or radiotherapy and be at least 14 days past the date of their last treatment
Received any anti-cancer or investigational therapy within 28 days prior to the first dose of study drug or has not recovered to less than Grade 2 clinically significant adverse effect(s)/toxicity(ies) of any previous therapy
Patients must have recovered from acute toxicity (to grade 1 or less) of all previous therapy prior to enrollment. Treatment may start earlier if necessitated by the patient's medical condition (e.g. progressive disease) following discussion with the Investigator.
Recovered from toxicity of previous chemotherapy (excludes grade 1 neurotoxicity and hematological toxicity)
Prior hormonal/endocrine therapy =< 2 weeks prior to study entry (except for letrozole, which does not need to be interrupted); patients must have recovered from toxicity > grade 1, except for alopecia
Prior HER2-targeted therapy < 3 weeks prior to study entry; patients must have recovered from toxicity > grade 1, except for alopecia
Must have recovered from acute toxicity from prior treatment
Patients must be at least 4 weeks from any prior treatments and have recovered (to < grade 2) from acute toxicity attributed to this prior treatment
Patients must have recovered from all prior therapy
Time lapse of 21 to 56 days between the end of onco-specific treatment and start of vaccination. Patients must have recovered from any acute toxicity produced by previous therapy.
Must be at least 21 days since treatment with chemotherapy, biochemotherapy, surgery, radiation, or immunotherapy, and recovered from any clinically significant toxicity experienced during treatment
Have not recovered (to baseline or Grade ?1) from toxicity associated with prior treatment.
If patient has received previous systemic treatment, at least 4 weeks must have elapsed since the last chemotherapy, radiotherapy or immunotherapy and the beginning of protocol therapy and the patient must have recovered from toxicity due to the previous therapy (i.e., toxicity has resolved to baseline or is deemed irreversible)
Discontinuation of prior anticancer therapy for ? 7 days prior to C1D1 and recovered to ? CTCAE grade 2 (or baseline) from any acute or chronic toxicity associated with prior therapy.
There are no limits on prior lines of therapy; however, patients must have recovered to eligibility levels from prior toxicity or adverse events as a result of previous treatment prior to entering the study (except alopecia)
Patients must have recovered (grade 1 or baseline) from any clinically significant toxicity associated with prior therapy
Patients with inadequate recovery from acute toxicity associated with any prior antineoplastic therapy.
The subject has not recovered from toxicity due to all prior therapies (i.e., return to pretherapy baseline or to grade 0 or 1)
Patients with inadequate recovery from acute toxicity associated with any prior antineoplastic therapy
Prior treatment with one to three lines of systemic chemotherapy for locally advanced or metastatic disease and two weeks from any previous anticancer therapy including biologics and recovered from expected toxicity; at least 4 weeks from major surgery and recovered; at least 3 weeks from radiation affecting more than 25% of bone marrow and recovered; and 2 weeks from other palliative radiation and recovered. No more than 450 mg/m2 cumulative dose of doxorubicin is allowed.
Participants who have not recovered from clinically significant adverse effect(s)/toxicity(s) of the previous therapy.
Patients must have recovered from toxicity of prior therapy
Recovered from toxicity of any prior therapy to grade 1 or better
Not recovered from toxicity due to all prior therapies.
Participants must have recovered to grade 1 toxicity from prior therapy
Any significant medical complications related to induction must have resolved
Patients must have resolved any serious infectious complications related to therapy
Any significant medical complications related to therapy must have resolved
CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Patients must have resolved any serious infectious complications related to therapy
CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Any significant medical complications related to therapy must have resolved
All associated clinically significant toxicity from previous cancer therapy must be resolved (to ?Grade 1 or baseline) prior to study treatment administration (Grade 2 alopecia is allowed).
Has an EGFR TKI- related toxicity that has NOT resolved to Grade 1 or less.
All acute, clinically significant treatment-related toxicity from prior therapy, except for alopecia, must have resolved to grade =< 1 prior to study entry
Toxicity from prior therapy (except alopecia) has resolved to ?Grade 1; in the event of toxicity that has not resolved to ?Grade 1 but is considered stable, the patient may be eligible after discussion among the investigator and sponsor's medical monitor.
Persistent toxicity from recent therapy that has not sufficiently resolved in the judgment of the study physician.
Prior treatment-related toxicity resolved to =< grade 2 or baseline
Acute, clinically significant treatment-related toxicity from prior therapy must have resolved to Grade </=1 prior to study entry
Resolved acute effects of prior therapy
All associated clinically significant drug-related toxicity from previous cancer therapy must be resolved prior to study treatment administration (alopecia is allowed).
All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline
Grade >= 3 non-hematologic toxicity from prior therapy that has not resolved to =< grade (G) 1
Any toxicity related to prior treatment must have resolved to Grade 1 or less, with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy
Residual or on-going >= grade 3 treatment-related toxicity from previous chemotherapy should be resolved
Grade >= 3 non-hematologic toxicity from previous therapy that has not resolved to =< grade (G)1
Grade >= 3 non-hematologic toxicity from previous therapy that has not resolved to =< grade 1
Grade >= 3 nonhematological toxicity from prior therapy that has not resolved to =< grade 1
Presence of an acute or chronic toxicity of prior chemotherapy that has not resolved to ? Grade 1, as determined by CTCAE v 4.0.
Grade >= 3 non-hematologic toxicity from previous therapy that has not resolved to =< grade 1
Grade >= 3 non-hematologic toxicity from prior therapy that has not resolved to =< grade 1 (G1).
All acute, clinically significant treatment-related toxicity from prior therapy, except for alopecia, must have resolved to grade =< 1
Any significant medical complications related to induction must have resolved
Patients must have resolved any serious infectious complications related to consolidation cycle 2
Any significant medical complications related to consolidation cycle 2 must have resolved
Patients must have recovered from acute toxicities of prior chemotherapy or stem cell transplant; any prior non-hematologic vital organ toxicity (cardiac, pulmonary, hepatic, renal) of previous therapy must have resolved to grade 1 or less
Any toxicity related to prior EGFR inhibitor treatment must have resolved to Grade 1\n             or less
Grade 3 or 4 immune related toxicity associated with prior ipilimumab therapy that has not resolved to grade 0 or 1
Resolved acute effects of any prior therapy to baseline or Grade ?1
All acute treatment-related toxicity must have resolved to Grade less than or equal to (</=) 1 or be deemed stable by the Investigator
Prior history of >= grade 2 neurotoxicity or any other toxicity requiring discontinuation of taxane therapy that has not resolved to =< grade 1, with the exception of alopecia
Toxicity from prior therapy (excluding alopecia) that has not resolved to =< grade 1 prior to the first treatment with G-202
Toxicity from prior radiation therapy has NOT resolved to grade 1 or less
All AEs while receiving prior immunotherapy must have resolved to ? Grade 1 or baseline prior to screening for this study.
All toxicity related to prior cancer therapies must have resolved to ? Grade 1, with the following exceptions: alopecia; neuropathy, which must have to resolved to ? Grade 2; and congestive heart failure (CHF), which must have been ? Grade 1 in severity and must have resolved completely.
Resolved acute effects of prior therapy
Any grade 3 or 4 -hematologic toxicity of previous therapy must have resolved to grade 2 or less prior to apheresis and any grade 3 or 4 toxicity must have resolved to grade 2 or less prior to pre-infusion lymphodepletive chemotherapy.
Any toxicity related to prior cancer therapies that has not resolved to =< grade 1, with the exception of peripheral neuropathy, which must have resolved to =< grade 2, and alopecia
Toxicity from prior chemotherapy that has not resolved to Grade ? 1;
All previous cytotoxic chemotherapy must be completed at least 2 weeks prior to study entry, with the exception of the tyrosine kinase inhibitors imatinib, nilotinib and dasatinib which may be continued through induction therapy; any grade 3 or 4 nonhematologic toxicity of any previous therapy must have resolved to grade 2 or less, unless specified elsewhere
All associated toxicity from previous or concurrent cancer therapy must be resolved (to ?Grade 1 or Baseline) prior to study treatment administration
All associated toxicity from previous or concurrent cancer therapy must be resolved (to ? Grade 1 or Baseline) prior to study treatment administration.
All associated toxicity from previous or concurrent cancer therapy must be resolved (to ? Grade 1 or Baseline) prior to study treatment administration.
All acute treatment-related toxicity from prior therapy must have resolved to Grade ? 1 prior to study entry
Acute prior study treatment related toxicity (except alopecia) that has not resolved to Grade < or = to 1 unless it has been deemed stable by the investigator
All acute treatment-related toxicity from prior therapy must have resolved to Grade ? 1 prior to study entry
Patients with grade >= 3 non-hematologic toxicity from previous therapy that has not resolved to =< grade 1
All acute treatment-related toxicity from prior therapy must have resolved to Grade ? 1 prior to study entry
All acute treatmentrelated toxicity from prior therapy must have resolved to Grade ? 1 prior to study entry
The patient has a prior ALK-inhibitor-related toxicity or any other prior therapy-related acute toxicity that has not resolved prior to the first dose of study drug.
Residual > Grade 2 toxicity from prior treatment must have resolved with the exception of those explicitly described elsewhere in entry criteria
Presence of an acute or chronic toxicity resulting from prior anti-cancer therapy, with the exception of alopecia, that has not resolved to Grade ? 1 within 7 days prior to start of CA-4948 unless approved by the Medical Monitor
Clinically significant toxicity (other than alopecia) from prior therapy that has not resolved to Grade ? 1 (according to the NCI CTCAE, v4.0) prior to Cycle 1 Day 1
All previous therapy must be completed at least 2 weeks prior to study entry; any grade 3 or 4 non-hematologic toxicity of any previous therapy must have resolved to grade 2 or less, unless specified elsewhere
Grade >= 3 non-hematologic toxicity from prior therapy that has not resolved to =< G1
All acute, clinically significant treatment-related toxicity from prior therapy, except for alopecia, must have resolved to grade =< 1
Any grade 3 or clinically significant grade 2 treatment-related non-hematological toxicity must be resolved to grade 1 before retreatment with chemotherapy (with exception of alopecia)
Any grade 3 or 4 hematologic toxicity of any previous therapy must have resolved to grade 2 or less prior to apheresis and any grade 3 or 4 toxicity must have resolved to grade 2 or less prior to pre-infusion lymphodepletive chemotherapy.
Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the investigator should not exclude the participant a. Any known history of Grade 4 thrombocytopenia with any prior chemotherapy regimen
With the exception of alopecia or toxicities related to the use of gonadotropin-releasing hormone agonists any unresolved toxicities from prior therapy greater than CTCAE grade 1 at time of study treatment
At least 2 weeks since the last systemic therapy regimen prior to enrollment. Subjects must have recovered to NCI CTCAE v4.03 Grade 1 or less from all acute toxicities (excluding Grade 2 toxicities that are not considered a safety risk by the Sponsor and Investigator) or toxicity must be deemed irreversible by the Investigator.
Resolution of treatment-related toxicities
At least 1 week since the last systemic therapy regimen prior to Cycle 1 Day 1. Subjects must have recovered to NCI CTCAE v. 4.03 < Grade 2 from all acute toxicities (excluding Grade 2 toxicities that are not considered a safety risk by the Sponsor and Investigator) or toxicity must be deemed irreversible by the Investigator.
All clinically significant toxicities from prior systemic therapy must be =< grade 1 (with the exception of alopecia, endocrinopathies associated with prior immunological therapies as long as they are stable with replacement therapy, and peripheral neuropathy, which may be =< grade 2)
Recovery from prior treatment-related toxicities
Not recovered to less than or equal to Grade 1 toxicities (except Grade 2 alopecia or neuropathy) associated with previous cancer therapies
Toxicities due to prior therapy must be stable and recovered to =< grade 1 (except for clinically non-significant toxicities, such as alopecia, nutritional support measures, electrolyte abnormalities, or those not impacting the investigator’s ability to assess treatment emergent toxicities)
The patient has persistent clinically significant ?Grade 2 toxicities from previous anticancer therapy (excluding Grade 2 chemotherapy-related neuropathy which is permitted, and excluding Grade 2-3 laboratory abnormalities if they are not associated with symptoms, are not considered clinically significant by the Investigator, and can be managed with available medical therapies).
Ongoing prior toxicities related to previous treatments must be recovered to < grade 2 at the time of registration (with the exception of alopecia, grade 2 peripheral neuropathy or lymphopenia)
Insufficient recovery from all active toxicities of prior therapies
Toxicities related to prior therapy must have returned to Grade 1 or less, except for alopecia.
Resolution of all chemotherapy or radiation-related toxicities to ? Grade 1
Resolution of all clinically significant treatment-related, non-hematological toxicities, except alopecia, from any previous cancer therapy to =< grade 1 prior to the first dose of study treatment
> 21 days from therapeutic radiation or chemotherapy (>6 weeks from nitrosoureas and mitomycin C) and recovery to (NCI CTCAE v4.03) Grade ? 1 from all clinically significant toxicities related to prior therapies.
Resolution of treatment-related toxicities.
All persistent clinically significant toxicities from prior chemotherapy must be less than or equal to grade 1
Has been receiving erlotinib, gefitinib, or afatinib for at least 6 weeks with well-controlled related toxicities less than Grade 3 in severity at the time of screening period.
Toxicities due to prior therapy must be stable and recovered to =< grade 1 (except for clinically non significant toxicities such as alopecia)
Resolution of all treatment-related, non-hematological toxicities, except alopecia, from any previous cancer therapy to < grade 1 prior to the first dose of study treatment
Resolution of all toxicities from prior therapy to ?Grade 1 (or baseline) within 1 week prior to the first dose of study drug (excluding alopecia and ?Grade 3 clinically asymptomatic lipase, amylase, and creatine phosphokinase laboratory abnormalities).
Recovery to =< grade 1 from all toxicities associated with prior therapy except alopecia
Patients with active infection, un-resolving more than grade 2 transplant-related toxicities
Baseline toxicities from prior anti-cancer treatments > grade 1
Has no prior treatment-related toxicities >Grade 1 (except alopecia) at the time of enrolment.
Resolution of all treatment-related toxicities, except alopecia, anemia and neuropathy, from any previous cancer therapy to ? Grade 1 prior to the first dose of study treatment.
No toxicities related to prior treatment related toxicities with the exception of alopecia and neuropathy
Non-hematological toxicities ? Grade 2
Patients must have recovery from other clinically significant, non-hematologic toxicities to =< grade 2
Recovery from >= grade 2 toxicities of prior therapy regimen to grade 1 or baseline, with the exception of anemia and lymphopenia and chronic residual toxicities that in the opinion of the investigator are not clinically relevant given the known safety/toxicity profiles of gemcitabine, sorafenib, and vorinostat (eg, alopecia, changes in pigmentation, stable endocrinopathies); patients with =< grade 2 peripheral sensory or motor neuropathy are eligible
All prior treatment-related toxicities must be =< grade 1
Persistent toxicities >= grade 2 from prior chemotherapy or biological therapy regardless of interval since last treatment
Recovery of all chemotherapy or radiation-related toxicities to grade =< 1, except for alopecia and peripheral neuropathy
Insufficient recovery from all active toxicities of prior therapies
Hydroxyurea may be used to control leukocytosis and can be taken until day 1 of therapy; patients with persisting, non-hematologic, non-infectious toxicities from prior treatment =< grade 2 are eligible, but must be documented as such
Clinically significant toxicities from prior chemotherapy must not be greater than grade 1
Patients must demonstrate resolution of all toxicities related to prior chemotherapy, endocrine therapy, or biologic therapy to grade =< 1, including peripheral neuropathy, with the exception of alopecia (any grade permissible)
Prior treatment with an investigational agent is allowed but must have been completed >= 28 days prior to randomization with resolution of all treatment-related toxicities to grade =< 1.
Prior radiotherapy must be completed >= 14 days prior to randomization with documentation of adequate recovery from associated toxicities to grade =< 1
Resolution of chemotherapy, immunotherapy or radiation-related toxicities.
Persistent toxicities caused by previous cancer therapy; toxicities should have recovered to =< grade 1, excluding alopecia and stable chronic grade 2 toxicity that is not overlapping with presumed toxicities of olaparib
Persistent toxicities >= grade 3 from prior chemotherapy or biological therapy regardless of interval since last treatment
Recovery to =< grade 1 toxicities associated with prior therapy
All prior treatment-related toxicities must be CTCAE v4 grade =< 1 (except alopecia) at the time of randomization
Patients must have recovered from all non-hematologic toxicities to =< grade 2 and from all hematologic toxicities to =< grade 3 prior to registration
Recovery to from toxicities related to any prior treatments.
The patient has persistent clinically significant toxicities Grade ? 2 from previous chemotherapy (excluding alopecia, nausea, fatigue, and liver function tests (as mandated in the inclusion criteria)).
All prior treatment-related toxicities must be CTCAE v4 grade =< 1 (except alopecia) at the time of randomization
Resolution of all toxicities related to prior therapies to ? NCI-CTCAE Grade 1 severity, except for alopecia, vitiligo, or endocrinopathies on replacement therapy.
Baseline toxicities from prior anti-cancer treatments > grade 1
Resolution of treatment-related toxicities except alopecia
A minimum of two weeks since last dose of most recent RCC therapy assuming resolution of clinically significant treatment-related toxicities to grade 1, baseline, or controlled with supportive medications
Recovered from all toxicities associated with prior treatment, to acceptable baseline status or grade 1 or less, except for toxicities not considered a safety risk, such as alopecia or vitiligo; peripheral neuropathy must be grade 2 or less
Recovery to =< grade 1 toxicities associated with prior therapy
With the exception of alopecia or toxicities related to the use of gonadotropinreleasing hormone agonists, any unresolved toxicities from prior therapy greater than CTCAE Grade 2 at the time of starting study treatment.
Grade 2 or greater toxicities from prior therapy, except for Grade 2 toxicities that are not expected to resolve and that in the judgment of the Investigator do not pose a significant safety risk to subject participation.
Any >grade 1 persistent clinically significant toxicities from prior chemotherapy.
Recovery from non-hematological toxicities of prior therapy (including HSCT) to no more than grade 1 (except alopecia)
Recovery to =< grade 1 from all significant toxicities of previous therapies
Resolution of all chemotherapy or radiation-related toxicities to grade 1 severity or lower except for alopecia
Persistent toxicities >= grade 2 from prior chemotherapy or biological therapy regardless of interval since last treatment
Participants may have received radiotherapy for palliative purpose, but must not be experiencing > grade 1 treatment related toxicities, and must have completed treatment > 14 days prior to registration
Adequate recovery of drug related toxicities, surgery or radiation therapy
Recovery to Grade 1 from all clinically significant adverse events related to prior MF therapy, including transplant-related toxicities.
All clinically significant toxicities from prior chemotherapy must be ? Grade 1.
The interval from prior treatment to time of study drug administration is at least 1 week (except for hydroxyurea or steroid therapy) with recovery from all prior therapy-related toxicities
Ongoing toxicities >= grade 2 from prior therapy
Resolution of prior treatment associated toxicities to ? grade 1
At least 2 weeks since last cytotoxic chemotherapy, hormonal therapy, or radiotherapy; toxicities related to prior therapy must either have returned to grade 1, or baseline (excluding alopecia)
Patients should be without any persisting clinically significant > grade 2 hematological/non hematological toxicities from previous treatments that would preclude evaluation of toxic effects of study treatment; grade 1 residual toxicity will be acceptable; patients should be off previous treatment at least 2 weeks from prior therapies before treatment start
Resolution of all prior treatment-related toxicities to Grade 1 or less, except for Grade 2 fatigue or alopecia prior to C1D1
For Part A only: Participants who did not recover from all clinically significant toxicities (excluding alopecia and hematologic toxicities) of any previous surgery, radiotherapy, targeted therapy, or chemotherapy to less than or equal to Grade 1
Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or Grade 1 toxicities which, in the opinion of the Investigator, should not exclude the patient.
Must have full recovery from any toxicities from prior therapy CTCAE Grade 1 or less with the exception of Grade 2 alopecia) prior to randomization.
Inadequate recovery from any toxicities related to prior treatment (to grade 1 or baseline)
Prior treatment toxicities must be ? Grade 1
Resolution of all prior ONT-10 related toxicities to ? Grade 1in severity
Recovery to =< grade 1 toxicities associated with prior therapy
The patient has persistent and clinically significant Grade ?2 toxicities from induction or consolidation therapy (excluding alopecia, nausea, fatigue, and liver function tests [as mandated in the inclusion criteria]) not readily managed with supportive measures.
Patients with existing grade 2 toxicities, except as approved by the investigator
Failure to recover from all prior treatment-related non-hematological toxicities to ? Grade 1 prior to the first scheduled dose of MEDI7247 (except for alopecia and neuropathy).
Subject that has toxicity from previous anti-cancer therapy must have recovered to ? Grade 1 (except for non-clinically significant toxicities, e.g., alopecia, vitiligo). Subjects with Grade 2 toxicities that are deemed stable or irreversible (e.g. peripheral neuropathy) can be enrolled.
SUBJECT: Must be off anti-neoplastic therapy for at least 2 weeks and all therapy-related toxicities should return to baseline or =< grade 1 if previously nonexistent.
Has been receiving erlotinib for treatment of NSCLC with erlotinib-related toxicities well-controlled and less than Grade 3 in severity at screening
Persistent clinically significant grade >= 2 toxicities (as per >= CTCAE v4) related to prior cancer therapy
All toxicities should recover to grade 0 or 1 prior to day 1
Has been receiving erlotinib, gefitinib, afatinib, or osimertinib for at least 6 weeks with well-controlled related toxicities less than Grade 3 in severity at the time of Screening
Toxicities due to prior therapy must be recovered to baseline or ? grade 1, except for clinically non-significant toxicities such as alopecia
Resolution of any clinically significant non-hematological toxicities (if any) from previous treatments to ? Grade 1 by C1D1.
Treatment-related toxicity from prior therapy > grade 2
Persisting toxicity related to prior therapy (NCI CTCAE v4.03 Grade > 1)
Subject has any Grade ? 2 persistent non-hematological toxicity related to allotransplant
Participants must have fully recovered (grade =< 1 or baseline or deemed irreversible) from any clinically significant acute toxicity related to prior therapy (with the exception of lymphopenia, which is common after therapy with temozolomide); patients who discontinued bevacizumab previously due to a bevacizumab-related toxicity will not be allowed to participate
Failure to recover from any immune-related toxicity from prior cancer therapy to ? Grade 1.
Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to ? Grade 2.
Toxicity related to any prior therapy must either have returned to =< grade 1 or baseline
Patients must have recovered from any acute toxicity related to prior therapy, including surgery; toxicity should be =< grade 1 or returned to baseline
Patient with any active immune toxicity of Grade 1 or greater or any other severe or Grade 3 treatment-related adverse event.
At least 4 weeks after any prior chemoembolization, radioembolization, local ablative therapies, or hepatic radiation and recovery to =< grade 1 treatment-related toxicity
At least 6 weeks after any major surgery including prior hepatic resection and recovery to =< grade 1 treatment-related toxicity
Persisting toxicity related to prior therapy >Grade 1
Toxicity related to prior treatments must either have resolved to grade 1 or less, returned to baseline, or be deemed irreversible
Patients must have recovered from any acute toxicity related to prior therapy, including surgery; toxicity should be =< grade 1 or returned to baseline
Patients must have recovered from any acute toxicity related to prior therapy, including surgery; toxicity should be =< grade 1 or returned to baseline
To be eligible for study treatment, radiation therapy-related toxicity must recover to Grade ? 1 prior to administration of the first dose of ARQ 751.
Recovered (returned to ? grade 1 as per CTCAE v4.03) from prior treatment-related toxicity.
Toxicity related to prior therapy must either have returned to =< grade 3, baseline, or deemed irreversible
Non-hematological toxicity related to prior therapy must either have returned to =< grade 3, baseline, or deemed irreversible
Toxicity from previous treatment including: a) Toxicity Grade >=3 related to prior immunotherapy and that lead to study treatment discontinuation. b) Toxicity related to prior treatment has not resolved to Grade <=1 (except alopecia, or endocrinopathy managed with replacement therapy).
Persisting toxicity related to prior therapy Grade >1.
Prior Grade 3 or higher immune-related AEs or any ocular toxicity on prior immunotherapy as per protocol-defined criteria.
Severe immune-related toxicity related to checkpoint inhibitors defined as any Grade 4 toxicity or Grade 3 toxicity
Severe immune-related toxicity related to checkpoint inhibitors defined as any Grade 4 toxicity or Grade 3 toxicity
Toxicity related to prior therapy must either have returned to =< grade 1, baseline, or been deemed irreversible
Toxicity related to prior therapy must either have returned to less than or equal to grade 1, baseline, or been deemed irreversible
Any Grade ? 2 persistent non-hematological toxicity related to allotransplant
Resolution of all chemotherapy related grade III-IV toxicity
History of significant intolerance to capecitabine or fluorouracil (5FU) (ie. grade 4 toxicity related to one of these agents; grade 3-4 toxicity related to other concurrently administered agents is not an exclusion)
Persisting toxicity related to prior therapy except alopecia
Grade 3 or 4 toxicity related to prior VEGFR TKI that did not resolve to grade 1
Toxicity related to prior therapy must either have returned to =< grade 1, baseline, or been deemed irreversible. Certain non-serious exceptions include alopecia, hypothyroidism, neuropathy, nausea, adrenocortical deficiency requiring physiologic replacement dose of steroids, and other conditions noted and approved by the principal investigator (PI).
Toxicity related to prior therapy must either have returned to =< grade 1, baseline, or been deemed irreversible. Certain non-serious exceptions include alopecia, hypothyroidism, neuropathy, nausea, adrenocortical deficiency requiring physiologic replacement dose of steroids, and other conditions noted and approved by the PI.
Patients are not eligible if they have an intolerance to most recent prior TKI (other than dasatinib) at the lowest possible effective dose, defined as a grade >= 3 toxicity considered at least possibly related to that TKI; patients are also excluded if they are intolerant or allergic to dasatinib and discontinued prior therapy due to a >= grade 2 treatment related adverse event
Recovery from acute toxicity related to prior therapy, including surgery and radiation, or no toxicity >= grade 2
Patients must have recovered from any acute toxicity related to prior therapy, including surgery; toxicity should be =< grade 1
Toxicities related to prior therapy must either have returned to =< grade 1, baseline, or deemed irreversible
Toxicities related to prior therapy must either have returned to =< grade 1, baseline or deemed irreversible
Inadequate recovery from any toxicity related to prior treatment (to grade 2 or baseline)
Persisting toxicity related to prior therapy >Grade 1
Recovery from acute toxicity related to prior therapy, including surgery and radiation, or no toxicity >= grade 2
Patients must have recovered from any acute toxicity related to prior therapy, including surgery; toxicity should be =< grade 1 or returned to baseline
Grade > 2 treatment-related toxicity from prior therapy
Toxicities related to prior therapy must either have returned to =< grade 1 or baseline or been deemed irreversible and in the opinion of the investigator not worsened
Resolution of all chemotherapy related grade III-IV toxicity as per Common Toxicity Criteria (CTC) criteria 4.0
Resolution of all chemotherapy related grade III-IV toxicity as per CTC criteria 4.0
PRIOR TO HIGH-DOSE CHEMOTHERAPY: Patients without evidence of ongoing grade III-IV toxicity related to mobilization therapy
Grade > 2 treatment-related toxicity from prior therapy
Grade > 2 treatment-related toxicity from prior therapy
Treatment related residual toxicity > grade 1
Patients must have recovered from any acute toxicity related to prior therapy, including surgery; toxicity should be =< grade 1 or returned to baseline
Patients must have recovered from any acute toxicity related to prior therapy, including surgery; toxicity should be =< grade 1 or returned to baseline
Resolution of all chemotherapy related grade III-IV toxicity as per Common Toxicity Criteria (CTC) criteria 4.0
Resolution of all chemotherapy related grade III-IV toxicity as per CTC criteria 4.0