Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy
Patients must have fully recovered from any adverse effects of major surgery (to =< grade 1) at least 14 days prior to registration
Patient must have fully recovered from the effects of prior surgery at least 14 days prior to sub-study registration
Patients who relapse on frontline therapy in phases other than maintenance must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Patient who has received radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to treatment start, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom >= 30% of the bone marrow was irradiated
Patients must have received prior therapy other than surgery and must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the defined eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
Recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy
Prior cancer treatment must be completed at least 28 days prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to =< grade 1 or baseline
Received radiotherapy =< 28 days or limited field radiation for palliation =< 14 days prior to registration, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom >= 25% of the bone marrow was irradiated
Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment\r\n* EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy
Subjects must have recovered from treatment toxicities to =< grade 1 or to their pretreatment levels; subjects who have developed interstitial lung disease (ILD) must have fully recovered
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
Recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy to CTCAE v4.03 grade 1, baseline or less, except for alopecia
Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from acute effects of any prior therapy to baseline or grade =< 1 except for alopecia or adverse events (AEs) not constituting a safety risk in the opinion of the investigator
Resolution of all toxic side effects from prior oncology treatments
Patients must have fully recovered (Eastern Cooperative Oncology Group [ECOG] 0-1) from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Subject has recovered (i.e., to Grade ? 1 or to a baseline level) from the effects of surgery, radiotherapy, chemotherapy, hormonal therapy, or other therapies for cancer; with the exception of vitiligo, alopecia, neuropathy, partial hearing loss, and/or endocrinopathies (for which no resolution is required);
Major surgery =< 2 weeks prior to registration or who have not recovered from side effects of such therapy; subjects must have recovered from any effects of recent radiotherapy that might confound the safety evaluation of study drug
Has recovered from the toxic effects of prior therapy to their clinical baseline
Have not fully recovered from the acute toxic effects of prior anticancer therapy (e.g., chemotherapy, immunotherapy, radiation therapy) or are currently receiving cytotoxic chemotherapy, immunotherapy or radiation therapy. A minimum period of 4 weeks / 28 days is required between the end of prior anticancer therapy and the initiation of TB-403.
Participants who have received radiotherapy =< 2 weeks prior to starting study drug, and who have not recovered to grade 1 or better from related side effects of such therapy (except alopecia and neuropathy) and/or in whom >= 25% of the bone marrow was irradiated
Patients must have fully recovered from the acute toxic effects of chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Recovered to Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies
Subjects must have fully recovered from the acute toxic effects of all prior anti-cancer therapy
Failure to have fully recovered (i.e., =< grade 1 toxicity or to patient’s clinical baseline) from the reversible effects of prior chemotherapy
Patient who has received radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom >= 30-25% of the bone marrow was irradiated
Patient who has received radiotherapy =< 4 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia), and/or in whom >= 25% of the bone marrow was irradiated
Patients must have recovered from effects of recent surgery, radiotherapy, or chemotherapy; they should be free of significant infection
Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment.
Have discontinued all previous therapies for breast cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy), except for ongoing corresponding combination therapy, for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug(s), and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy. For Part F and H: concurrent treatment with trastuzumab emtansine (T-DM1) is not allowed.
Patients must have recovered from the effects of any prior chemotherapy, as determined by the treating physician and study team, based in part on organ function defined above
Participants must have recovered from any acute toxicity associated with prior therapy
Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy or radiotherapy prior to entering this study
Recovered from the toxic effects of all prior chemotherapy before entering this study
Patient must have recovered from any toxic effects of previous chemotherapy, targeted therapy or radiotherapy as judged by the investigator to ? grade 1
Subjects must have recovered from major side effects of prior therapies or procedures.
Be fully recovered from major surgery and from the acute toxic effects of prior chemotherapy and radiotherapy. Residual chronic toxicities of prior therapy ? grade 2 (eg, peripheral neuropathy, residual alopecia) are allowed.
Has resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (except alopecia). If the participant received major surgery or radiation therapy of >30 Gray units, they must have recovered from the toxicity and/or complications from the intervention
Has not fully recovered from any effects of major surgery without significant detectable infection.
Prior radiotherapy is acceptable provided the patient has recovered from any radiotherapy related acute toxicities.
Resolution of all acute toxic effects of prior therapy or surgical procedures to Grade ?1 (except alopecia).
Participant has received radiotherapy ?4 weeks or limited field radiation for palliation ?2 weeks prior to starting study drug, and who has not recovered to Grade 1 or better from related side effects of such therapy (with the exception of alopecia) and/or for whom ?30% of the bone marrow was irradiated.
All clinically significant toxic effects (except peripheral neuropathy) of prior locoregional therapy, surgery, or other anticancer therapy have resolved to =< CTCAE grade 1
Patient who has received radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom >= 25% of the bone marrow was irradiated
Must have completely recovered or recovered to baseline prior to screening from any prior AEs occurring while receiving prior immunotherapy.
INCLUSION - TREATMENT: Recovered from acute toxic effects of prior chemotherapy at least one week before entering this study
Patient who has received radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) or in whom >= 25% of the bone marrow was irradiated
Recovered from the toxic effects of prior therapy to < grade 2 toxicity per NCI CTCAE prior to study registration (except lymphopenia).
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
Failure to have fully recovered (i.e. no toxicities > Grade 1) from the reversible effects of prior chemotherapy.
The patient must have failed at least one prior therapy besides surgery- radiation or chemotherapy (either cytotoxic or biologic agent)-prior to study registration; patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Has failed to recover from the reversible effects of prior anticancer therapy
INCLUSION - FUSION: Recovered from acute toxic effects of prior chemotherapy at least one week before entering the study
TREATMENT INCLUSION: Recovered from all acute non-hematologic toxic effects of all prior chemotherapy
The patient must have recovered from the effects of surgery, postoperative infection and other complications before enrollment;
Fully recovered from any effects of major surgery, and be free of significant infection
Failure to have fully recovered (ie, > grade 1 toxicity) from the reversible effects of prior chemotherapy
Have NO continuing acute toxic effects of any prior therapy, including but not limited to biological therapy, radiotherapy, chemotherapy, or surgical procedures, i.e., all such effects must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) grade =< 1; any other surgery (except biopsies) must have occurred at least 28 days prior to study enrollment
Has not recovered to Grade ?1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting therapy. Note: Subjects with Grade ?2 neuropathy is an exception and may enroll.
Failure to have fully recovered (ie, =< grade 1 toxicity) from the reversible effects of prior chemotherapy, except for laboratory abnormalities which are addressed above
Prior Therapy- Patients must have fully recovered from the acute toxic effects of all prior anti- cancer chemotherapy and be within the following timelines:
Patients who have received radiotherapy =< 2 weeks prior to starting study drugs, with exception of palliative radiotherapy, who have not recovered from side effects of such therapy to baseline or grade =< 1 and/or from whom >= 30% of the bone marrow was irradiated
Failure to have fully recovered (i.e., =< grade 1 toxicity) from the reversible effects of prior chemotherapy
Failure to recover to =< grade 1 from acute, reversible effects of prior chemotherapy, excluding alopecia regardless of interval since last treatment; (NOTE: patients with residual peripheral neuropathy are allowed)
Patients must have received prior radiation therapy and/or chemotherapy and recovered from the acute treatment related toxicities (defined as =< grade 1 if not defined in eligibility criteria) of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study; there is no upper limit to the number of prior therapies that is allowed
Patients must be fully recovered from all acute effects of prior surgical intervention
INCLUSION CRITERIA FOR STRATUM C: Patients must be fully recovered from all acute effects of prior surgical intervention
Subjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met; cytopenias deemed to be disease-related and not therapy-related are exempt from this exclusion
Having received treatment in another clinical study within the 30 days prior to commencing study treatment or having side effects of a prior study drug that are not recovered to grade ? 1 or baseline, except for alopecia
Patients must have received no more than 2 prior chemotherapy regimens and/or focal radiotherapy for their brain tumor and fully recovered from the acute treatment related toxicities of all prior therapies prior to entering this study; for those acute baseline adverse events attributable to prior therapy, patients must meet organ function criteria
Has recovered from the toxic effects of prior therapy to their clinical baseline
Fully recovered from acute toxic effects of any prior chemotherapy, biological modifiers or radiotherapy
All patients must, in the opinion of the study PI, have sufficiently recovered from significant acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
INCLUSION - TREATMENT: Recovered from the acute toxic effects of all prior chemotherapy
Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, and monoclonal antibodies =< 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
Patients must be recovered to grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies
Patients must be at least 4 weeks from radiation or surgery and recovered from all ill effects
Patients must have recovered from effects of prior therapy; at least 2 weeks should have elapsed since the last dose of high dose chemotherapy; hydroxyurea, steroids and vincristine are allowed to control counts until eligibility is confirmed and study treatment can be initiated
Participants must have fully recovered from the acute toxic effects of all prior treatment to grade 1 or less, except alopecia and =< grade 2 neuropathy which are allowed
Patients who relapse on therapy other than standard ALL maintenance must have fully recovered from the acute toxic effects of all prior anti-cancer therapy, defined as resolution of all such toxicities to ? grade 2 or lower per the inclusion/exclusion criteria prior to entering this study
Patients must have recovered to =< grade 1 or stabilized from the toxic effects of any prior chemotherapy (except alopecia)
Patients who have received chemotherapy or any investigational drug < 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment\r\n* NOTE: Patients can have peripheral (sensory) neuropathy
Prior cancer treatment (systemic therapy or radiation therapy) must be completed at least 3 weeks prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to grade =< 1 or baseline.
Subjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met; cytopenias deemed to be disease-related and not therapy-related are exempt from this exclusion
Patient must have recovered from acute toxic effects (? grade 1) of previous cancer treatments prior to enrollment
All acute toxic effects of any prior antitumor therapy resolved to Grade 1.
Resolved acute effects of prior therapy
Participants must have fully recovered from the acute toxic effects of all prior anticancer therapies or must adhere to post-treatment conditions as follows:
Patients must have recovered from the effects of prior therapy
Patients who have undergone surgery =< 3 weeks or who have not recovered from side effects of this procedure prior to receiving study drug
Patients must have received prior therapy other than surgery and must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, biologic therapy or radiotherapy prior to study entry
Patient is currently receiving or has received systemic corticosteroids (=< 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment)
Recovered from all acute side-effects (except alopecia) related to previous systemic therapy
Anticancer chemotherapy during the study or within 4 weeks of study enrollment; subjects must have recovered from the toxic effects of the previous anti-cancer chemotherapy (with the exception of alopecia); anti-cancer therapy is defined as any\r\nagent or combination of agents with clinically proven anti-tumor activity administered by any route with the purpose of affecting the malignancy, either directly or indirectly, including palliative and therapeutic endpoints
All subjects must, in the opinion of the study PI, have sufficiently recovered from significant acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
No chemotherapy, radiation, or major surgery within two weeks prior to first dose of study drug and/or recovered from the toxic side effects of that therapy, unless treatment is indicated due to progressive disease.
Patients who have not recovered from side effects of prior systemic therapy prior to cycle 1 day 1
Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
Patients may have had no more than one prior line of chemotherapy or immunotherapy in the metastatic setting; at least 14 days must have elapsed from the last chemo/immunotherapy administration until the start of protocol treatment, and patients must have recovered from the side effects of any of these agents
Patients must have recovered from effects of recent surgery, radiotherapy, or chemotherapy
Failure to have fully recovered (ie, =< grade 1 toxicity) from the reversible effects of prior chemotherapy
Recovered to Grade 1 or baseline from all toxic effects of previous therapy (except alopecia or neuropathy).
Participants must have fully recovered from the acute toxic effects of all prior anticancer treatments prior to study drug administration:
All subjects must, in the opinion of the study PI, have sufficiently recovered from significant acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Failure to have fully recovered (i.e., =< grade 1 toxicity) from the reversible effects of prior chemotherapy
Patients must have recovered from the toxic effects of prior therapy at the time of initiation of the study drug unless toxicity is stable
Must have recovered from adverse effects of any prior surgery, radiotherapy or other antineoplastic therapy
Have resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (except alopecia). If the patient received major surgery or radiation therapy of >30 Gy, they must have recovered from the toxicity and/or complications from the intervention.
Patient must have recovered from the acute toxic effects (? grade 1 CTCAE v.4.0) of previous anti-cancer treatment prior to study enrollment; the only exception is that grade 2 neuropathy is permitted
Recovered (i.e., ?Grade 1 nonhematologic toxicity) from the reversible effects of prior anticancer therapy.
Prior cancer treatment must be completed at least 14 days prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ?grade 1 or to baseline prior to initiation of that therapy.
Subject who has received radiotherapy <14 days prior to registration, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia).
Patient who has received radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom >= 25% of the bone marrow was irradiated
Patients who have not recovered from the toxic effects of prior chemo- and/or radiation therapy; guidelines for this recovery period are dependent upon the specific therapeutic agent being used:\r\n* Patients who are less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 consecutive scans with disease progression or histopathologic confirmation of recurrent tumor\r\n* Patients who have received chemotherapy or bevacizumab =< 4 weeks (except for nitrosourea [6 weeks] or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide [1 week]) prior to starting the study drug unless patients have recovered from side effects of such therapy\r\n* Patients who have received immunotherapy =< 4 weeks prior to starting the study drug unless patients have recovered from side effects of such therapy
Patients may have been previously treated for a plexiform neurofibroma but must have fully recovered from the acute toxic effects of all prior chemotherapy or radiotherapy prior to entering this study
Participants must have recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy (including but not limited to exceptions of alopecia, laboratory values listed per inclusion criteria, and lymphopenia which is common after therapy with temozolomide)
Patients must have resolution of toxic effects to grade 1 or less from prior therapy (except alopecia)
Patients who have not recovered from the toxic effects of prior chemo- and/or radiation therapy; guidelines for this recovery period are dependent upon the specific therapeutic agent being used
Patients may not have received immunotherapy =< 4 weeks prior to starting the study drug unless patients have recovered from side effects of such therapy
Patient is currently receiving or has received systemic corticosteroids =< 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment
Currently receiving or has received systemic corticosteroids within 4 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment (steroids for endocrine replacement is allowed)
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 the acute toxic effects of all prior therapy to =< grade 1 before entering this study
Recovered from the effects of any prior surgery, radiotherapy, or antineoplastic treatment (with the exception of alopecia), based on Investigator assessment
Failure to fully recover (i.e. =< grade 1 adverse event [AE]) from the reversible effects of prior chemotherapy
Have resolution of toxic effect(s) of the most recent prior chemotherapy to grade 1 or less (except alopecia); if subject received major surgery or radiation therapy of > 30 Gy, they must have recovered from the toxicity and/or complications from the intervention
Fully recovered from acute, reversible effects of prior therapy regardless of interval since last treatment;\r\n* EXCEPTION: neuropathies – if grade 2 neuropathies have been stable for at least 3 months since completion of prior treatment patient is eligible
Patients who have received the last administration of an anti-cancer therapy including chemotherapy, immunotherapy, and monoclonal antibodies ? 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
Patients must be deemed by the investigators to be fully recovered from both acute and late effects of any prior surgery, radiotherapy, or other antineoplastic therapy
Patients must have recovered from toxicity of prior therapy
All acute toxic effects of any prior radiotherapy, chemotherapy, experimental drug treatment or surgical procedure must have resolved to grade =< 1, except alopecia (any grade) and peripheral neuropathy
Must have completely recovered or recovered to baseline prior to screening from any prior adverse events (AEs) occurring while receiving prior immunotherapy.
Recovered from the effects of any prior surgery, radiotherapy, or antineoplastic treatment (with the exception of alopecia), based on Investigator assessment
Radiation therapy (within 12 weeks of Study Day 1 or has not recovered from the toxic effects of such therapy).
Gliadel® Wafer (within 6 months of Study Day 1, or has not recovered from the toxic effects of such therapy).
Immunotherapeutic agents, vaccines, or monoclonal antibody therapy (within 4 weeks of Study Day 1 or has not recovered from the toxic effects of such cancer therapy).
Temozolomide or other chemotherapy (within 4 weeks of Study Day 1 or 6 weeks for nitrogen mustards, or has not recovered from the toxic effects of such cancer therapy).
Surgical resection of brain tumor (within 4 weeks of Study Day 1 or has not recovered from acute side effects of such therapy except for neurological effects).
Recovered to grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies
Treatment with any of the following anti-cancer therapies prior to the first dose of BGJ398 within the stated timeframes\r\n* Cyclical chemotherapy (intravenous) within a period of 2 weeks unless there are ongoing side effects > grade 2\r\n* Biological therapy (including small molecules, and/or) within a period of time that is =< 2 weeks prior to starting study drug unless there are ongoing side effects > grade 2\r\n* Any other investigational agents within a period =< 2 weeks prior to starting study drug unless there are ongoing side effects > grade 2\r\n* Wide field radiotherapy (including radioisotopes) =< 2 weeks prior to starting study drug unless there are ongoing side effects > grade 2
Resolution of all acute toxic effects of prior therapy, including radiotherapy to grade ? 1 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Must have recovered from the acute toxic effects of all prior therapy prior to registration for this study to grade 1 or less
Failure to have fully recovered (i.e., =< grade 1 toxicity) from the reversible effects of prior ASCT chemotherapy
Patient who has received radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom >= 25% of the bone marrow was irradiated
CERITINIB INCLUSION CRITERIA: Resolution of all acute toxic effects (excluding alopecia) of prior radiotherapy, chemotherapy or surgical procedures to CTCAE v4.03 grade =< 1
REGORAFENIB INCLUSION CRITERIA: Resolution of all acute toxic effects (excluding alopecia) of prior radiotherapy, chemotherapy or surgical procedures to CTCAE v4.03 grade =< 1
ENTRECTINIB INCLUSION CRITERIA: Resolution of all acute toxic effects (excluding alopecia) of prior radiotherapy, chemotherapy or surgical procedures to CTCAE v4.03 grade =< 1
Subjects must have recovered from the toxic effects of any prior chemotherapy to < grade 1 (except alopecia)
Failure to have fully recovered (ie, =< grade 1 toxicity) from the reversible effects of prior chemotherapy
Treated with immunotherapeutic agents, vaccines, or monoclonal antibody (Mab) therapy within 4 weeks before enrollment, unless the patient has recovered from the expected toxic effects of such therapy
Treated with alkylating agents within 4 weeks (6 weeks for nitrosoureas) before enrollment or treated within 1 week before enrollment with daily or metronomic chemotherapy, unless the patient has recovered from the expected toxic effects of such therapy to their baseline or to grade 1
Prior treatment (non-alkylating agents) within 2 weeks before enrollment, unless the patient has recovered from the expected toxic effects of such therapy
Patient must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, radiotherapy, or surgery prior to study entry.
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Subjects in the combination treatment cohort must not have: a history or evidence of psychiatric, substance abuse, or any other clinically significant disorder; toxic effects of the most recent prior chemotherapy not resolved to grade 1 or less (except alopecia); or expected other cancer therapy while on study with the exception of local radiation to the site of bone or other metastasis for palliative treatment.
Patient must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Must have recovered from the toxic effects of all prior chemotherapy
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must have fully recovered from the acute toxic effects of all prior therapy including chemotherapy, radiotherapy and immunotherapy
Patients must have been off of cytotoxic, immunosuppressive (except steroids), or targeted therapy, including standard and investigational treatments for AA, for at least 1 week or 5 half-lives whichever comes later, prior to entering this study, and have recovered from the toxic effects of that therapy to Grade 1 or less.
Any active infection or infectious illness unless fully recovered prior to dosing.
Not recovered to Grade 1 from adverse effects of prior myeloma therapy or radiotherapy prior to screening.
Failure to have fully recovered (i.e., =< grade 1 toxicity) from the effects of prior chemotherapy regardless of the interval since last treatment
Failure to have fully recovered (ie, =< grade 1 toxicity) from the reversible effects of prior chemotherapy
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy or radiation to grade 2 or less
No chemotherapy or radiotherapy within the past 28 days and patients must have recovered any acute toxicity associated with their most recent previous treatment
Failure to have fully recovered (i.e., ? grade 1 toxicity) from the reversible effects of prior chemotherapy or endocrine therapy, except for grade 2 or greater anemia
At the time of registration, patient must have recovered from the toxic effects of prior therapy to no more than grade 1 toxicity
At least 2 weeks should have elapsed since the last dose of chemotherapy and must have recovered from the acute effects of prior therapy (grade 1 or better); however patients who have a > 50% rise in peripheral blast count (confirmed twice) or > 50% growth of lymph nodes are immediately eligible; patients who have relapsed following autologous or allogeneic bone marrow transplant (BMT) are eligible
Patients must have recovered from the toxic effects of prior therapy to grade 1 or better; patients must be at least 3 weeks form the last dose of standard cytotoxic chemotherapy or myelosuppressive biological therapy and at least 1 week from the last dose of non-myelosuppressive biologic therapy
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy:
Patients must have recovered (to Common Toxicity Criteria [CTC] version [v.]4.0 =< grade 1 unless indicated below) from the acute toxic effects of all prior chemotherapy, immunotherapy prior to entering this study, with the exception of alopecia, weight changes and grade I or II lymphopenia
Radiotherapy less than 2 weeks before the first dose of study treatment or have not recovered from acute toxic effects from radiotherapy.
Patient must, in the opinion of the study principal investigator (PI) or designee, have fully recovered from significant acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment onto this study
Must have recovered from toxic effects of prior chemotherapy
Treated with immunotherapeutic agents within 4 weeks before enrollment, unless the patient has recovered from the expected toxic effects of such therapy
Treated with alkylating agents within 4 weeks before enrollment (6 weeks for nitrosoureas) or treated within 1 week before enrollment with daily or metronomic chemotherapy, unless the patient has recovered from the expected toxic effects of such therapy
Prior chemotherapy (non-alkylating agents) within 2 weeks before enrollment, unless the patient has recovered from the expected toxic effects of such therapy
Patients must have recovered from the acute toxic effects of all prior anticancer chemotherapy
Previous chemotherapy, and/or biological therapy for cancer are permitted provided that the acoustic properties of the tumor were not affected; the subject should have recovered from the effects of these or of any prior surgery
Patients must have recovered from the toxic effects of prior therapy
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Prior Therapy- Patients must have fully recovered from the acute toxic effects of all prior anti- cancer chemotherapy and be within the following timelines:
Patients must be recovered from the effects of any prior chemotherapy, radiotherapy or surgery (i.e., toxicity no worse than Grade 1); for patients who have been on monoclonal antibody therapy, at least one half-life or 4 weeks (whichever is shorter) should have elapsed prior to the first scheduled day of dosing with PFK-158.
Recovered from effects of any prior surgery or cancer therapy
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
Recovered from reversible toxicities of prior therapy
Fully recovered from toxicity due to prior therapy
Patients must have recovered from the toxic effects of any prior chemotherapy to < grade 2 (except for alopecia)
Patients must have discontinued all previous systemic therapies and recovered from side effects due to systemic treatment for more than 14 days prior to starting on treatment
Patients must have discontinued all previous biologic therapies and recovered from side effects due to biologic treatment for more than 14 days prior to starting on treatment
Patients who have not recovered from side effects of prior anti-cancer treatment to less than or equal to grade 1 toxicity according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4 within the following time frames:\r\n* Received previous systemic therapy and has not recovered from side effects for more than 14 days prior to starting on treatment\r\n* Received previous radiation therapy and has not recovered from side effects for more than 14 days prior to starting on treatment\r\n* Received previous biologic therapy and has not recovered from side effects for more than 14 days prior to starting on treatment
Recovered from acute toxic effects of prior chemotherapy at least one week before entering this study
Prior radiation therapy completed >= 4 months, and/or chemotherapy completed >= 1 month before study entry, and patient should have recovered from any adverse effects
No acute toxic effects from previous treatment superior to grade 1 at the start of the study
Prior radiation therapy is permitted as long as:\r\n* Recovered from the toxic effects of radiation treatment before study entry, except for alopecia
Patients must have been off of cytotoxic, immunosuppressive (except steroids), or targeted therapy for at least 2 weeks prior to entering this study, and have recovered from the toxic effects of that therapy to grade 1 or less
Recent prior therapy: systematic chemotherapy less than 2 weeks prior to infusion; exceptions:\r\n* There is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such\r\n* Subjects receiving hydroxyurea or oral maintenance chemotherapy may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis or treatment\r\n* Subjects receiving steroid therapy at physiological replacement doses only are allowed provided there has been no increase in dose for at least 2 weeks prior to subject starting apheresis or treatment\r\n* Subjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met; cytopenias deemed to be disease-related and not therapy-related are exempt from this exclusion
Patients must have recovered from the acute treatment related toxicities (defined as =< grade 1) of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Patients must not have chemotherapy, radiotherapy, chemoembolization, radioembolization, or immunoembolization for their malignancy within 30 days prior to treatment and must have recovered from all side effects of therapeutic and diagnostic interventions except those listed in Appendix B of the study protocol.
Has not recovered from toxic effect of prior therapy to < Grade 1.
Have completed local therapy (surgical resection, WBRT, or SRS) ?14 days prior to initiating abemaciclib and recovered from all acute effects.
Recovered from the acute toxic effects of all prior chemotherapy at least one week and 30 days from prior chemotherapy before entering this study
Subjects must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study
Recovered from the acute toxic effects of all prior chemotherapy at least 4 weeks before entering this study
Greater than 2 weeks since last treatment (chemotherapy or radiation) provided subject has recovered from side effects of treatment prior to the study
Participants must have fully recovered from the acute toxic effects of all prior anticancer therapy and must meet the following minimum duration from prior anticancer directed therapy prior to study drug administration. If, after the required time frame, the numerical eligibility criteria are met, eg, blood count criteria, the participant is considered to have recovered adequately:
Have recovered from the effects of any prior radiotherapy or surgery;
Have recovered from the acute effects of any prior systemic therapy.
Failure to have fully recovered (i.e., =< grade 1 toxicity) from the reversible effects of prior chemotherapy
Resolution of all acute toxic effects of previous anticancer therapy
Failure to have fully recovered (that is, less than or equal to [<=] Grade 1 toxicity) from the reversible effects of prior chemotherapy.
Recovery from the effects of prior therapy:
Have recovered from any previous therapy side effects or toxicities
Patient must have recovered from toxicities incurred as a result of any previous anti-myeloma therapy or recovered to baseline.
Resolution of any toxic effects of previous therapies
Patients must have been off chemotherapy for 2 weeks prior to entering this study unless there is evidence of rapidly progressive disease. Patients must have recovered from the toxic effects of prior therapy to grade ?1. The use of hydroxyurea is allowed to control counts up to 24 hrs prior to the start of therapy with AR-67.
Recovered from all acute adverse effects of prior therapies, excluding alopecia (hair loss)
No chemotherapy, radiation, or major surgery within 2 weeks prior to first dose of study drug and recovered from toxic side effects of that therapy, unless treatment is indicated due to progressive disease.
Has not recovered to ? Grade 1 or baseline from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study treatment.
Patient received chemotherapy, surgery, or radiotherapy (for therapeutic purposes) within 3 weeks, monoclonal antibodies or investigational drugs within 4 weeks or tyrosine kinase inhibitor within 1 week, or the patient has not recovered (from grade ?2 side effects of the previous therapy) prior to lymphodepletion regimen. Note: Patient may be still eligible if the patient has not fully recovered from grade ?2 toxicities if accumulated toxicities with the lymphodepletion therapy are not expected
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Patients must have recovered from side effects resulting from prior cancer-directed therapy to a level of grade 1 or less (unless deemed not clinically significant by study investigator)
Failure to have fully recovered (i.e., ? grade 1 toxicity) from the reversible effects of prior treatment for WM
Resolution of all acute toxic effects of prior therapy or surgical procedure to grade 1 or baseline prior to randomization
Received radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to registration, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom >= 25 percent (%) of the bone marrow was irradiated
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
Prior chemotherapy, with the exception of hydroxyurea or low-dose cytarabine as stated above; the patient must have recovered from all acute toxicities from any previous therapy
Patients must be at least 4 weeks (28 days) from major surgery and fully recovered from all acute effects of prior surgical intervention
Subjects that have not recovered from side effects of previous therapy.
Patient has received radiotherapy ? 4 weeks or limited field radiation for palliation ? 2 weeks prior to enrollment, and who has not recovered to grade 1 or better from related side effects of such therapy
Participants must have recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy (including but not limited to exceptions of alopecia, laboratory values listed per inclusion criteria, and lymphopenia which is common after therapy with temozolomide)
Patients must have recovered from the effects of induction, re-induction, or consolidation chemotherapy (all toxicities =< grade I with the exception of reversible electrolyte abnormalities), and have no ongoing active infection requiring treatment
Failure to fully recover from acute, reversible effects of prior anti-cancer therapy regardless of interval since last treatment; NOTE: patients must have fully recovered from all acute, reversible toxicities (defined as Common Terminology Criteria for Adverse Events [CTCAE] 4.0 =< grade 1) associated with previous treatment
Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
Subjects must have recovered from the toxic effects of any prior chemotherapy to =< grade 1 (except alopecia)
Patients must have recovered from the toxic effects of prior therapies (=< grade 1)
Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, stem cell transplant or radiotherapy prior to entering this study; all prior treatment-related toxicities must have resolved to =< grade 2 prior to enrollment
Patients must have recovered from the acute effects of prior liver-directed therapy (e.g. RT, radiofrequency ablation [RFA], or transarterial chemoembolization [TACE]), and a minimum of 4 weeks must have passed since the last procedure and protocol therapy
Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
Patients must have recovered from toxicity of prior therapy
Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
Patients must have fully recovered from major surgery and from the acute toxic effects of prior chemotherapy and radiotherapy (residual grade 1 toxicity, e.g., grade 1 peripheral neuropathy, and residual alopecia are allowed)
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study enrollment
Participants must have recovered (to baseline/stabilization) from prior cytotoxic\n             therapy-associated acute toxicities.
Subjects must have recovered from all toxicity associated with previous chemotherapy,\n             targeted therapy, or radiotherapy
Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to Step 2 re-registration; patients must have recovered (=< grade 1) from any side effects of prior therapy
At least 3 weeks should have elapsed since the last treatment (e.g. chemotherapy, targeted small molecule therapy, immunotherapy or radiation) and must have recovered to grade 1 or better from the acute effects of prior therapy
Patients must have fully recovered from major surgery and from the acute toxic effects of prior chemotherapy and radiotherapy - residual grade 1 toxicity, e.g., grade 1 peripheral neuropathy and residual alopecia are allowed
Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to re-registration; patients must have recovered (=< grade 1) from any side effects of prior therapy
Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to step 2 re-registration; patients must have recovered (< grade 1) from any side effects of prior therapy
Patient who has received wide field radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug or who have not recovered to grade 1 or better from related side effects of such therapy (except alopecia)
Patient has not recovered to grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy
Patient is currently receiving or has received systemic corticosteroids =< 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment
Patient who has received radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom >= 25% of the bone marrow was irradiated
At least 3 weeks must have elapsed from any prior chemotherapy, and the patient must have recovered from side effects to =< grade 1 toxicities
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Patients who relapse on therapy other than standard ALL maintenance therapy must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Patient who has received radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom >= 25% of the bone marrow was irradiated
Patients who have not recovered to grade =< 1 or to their baseline from clinically significant adverse effects
Subject is currently receiving or has received systemic corticosteroids =< 2 weeks prior to starting study drug or who have not fully recovered from side effects of such treatment
All patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy
Patients who have received radiotherapy =< 4 weeks prior to starting study drugs, with exception of palliative radiotherapy, who have not recovered from side effects of such therapy to baseline or grade =< 1 and/or from whom >= 30% of the bone marrow was irradiated
At least 3 weeks has elapsed from any prior therapy, and the patient has recovered from side effects to =< grade 1 toxicities per Common Toxicity Criteria (CTC)
Failure to have fully recovered (i.e., =< grade 1 toxicity) from the reversible effects of prior chemotherapy, excluding alopecia
Recovered from the toxic effects of all prior chemotherapy
Subjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met; cytopenias deemed to be disease-related and not therapy-related are exempt from this exclusion
Patients must be recovered from both the acute and late effects of any prior surgery, radiotherapy, or other antineoplastic therapy
Patients must be recovered from both the acute and late effects of any prior surgery, radiotherapy, or other antineoplastic therapy
Failure to fully recover from acute, reversible effects of prior chemotherapy (other anti-neoplastic therapy) and radiation therapy
Recovered from the acute toxic effects of all prior chemotherapy at least a week before entering this study
Recovered from the toxic effects of all prior chemotherapy before entering this study
Patients must have recovered from effects of recent surgery, radiotherapy or chemotherapy
Subject has recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to first dose. All prior treatment-related toxicities must have resolved to ? Grade 2 prior to enrollment.
Subjects must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer.
Patient has not recovered from clinical and laboratory acute toxicities of chemotherapy, radiotherapy and surgery
discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture at least 2 weeks prior to randomization and recovered from the acute effects of therapy
discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and endocrine therapy), except trastuzumab, for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy
Patient must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer
PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have recovered from any adverse effects from prior therapy (except alopecia) to =< CTCAE grade 1 prior to registration
Must have recovered (ie, ? Grade 1 toxicity or participant's baseline status) from the reversible effects of prior therapy
Patients who have received any antineoplastic therapy > 28 days prior to starting treatment with ABC294640 and have not adequately recovered from side effects and toxicities of previous antineoplastic therapy.
Patients not recovered to Grade 1 or stabilized from the effects (excluding alopecia) of any prior therapy for their malignancies
Has not recovered to ? Grade 1 from toxic effects of prior therapy.
Has not recovered from toxic effects of prior therapy to ? Grade 1.
Recovery from the toxic effects of prior therapy, with a minimum time of:
Have recovered from any acute toxicity related to prior therapy.
All acute toxic effects of any prior antitumor therapy resolved to Grade ? 1 before the start of study drug
Participant must have resolution to Grade 1 or lower of any toxic effects (excepting alopecia) of the most recent therapy prior to Cycle 1 Day 2.
Resolution of all clinically relevant acute non-hematologic toxic effects of any prior antitumor therapy resolved to Grade <=1
Patient has received radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom >= 30% of the bone marrow was irradiated
Complete resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (except alopecia). If the subject received major surgery or radiation therapy of > 30 Gy, they must have recovered from the toxicity and/or complications from the intervention.
Failure to fully recover from acute, reversible effects of prior chemotherapy (other anti-neoplastic therapy) and radiation therapy to adverse event severity of =< grade 1
Resolved acute effects of any prior therapy to baseline or Grade ?1
Patients must have recovered (to baseline/stabilization) from prior therapy-associated acute toxicities.
Patient must have recovered from the acute toxic effects of the treatment before beginning study therapy.
The subject has adequately recovered from toxicities due to prior therapy.
Resolution of any toxic effects (excepting alopecia) of the most recent therapy
Adverse effects due to prior therapy unresolved at randomization
Previous chemotherapy for local recurrence is allowed but must have been discontinued at least 4 weeks before receiving the study drug and the patient must have recovered from acute adverse effects
Previous radiation therapy was allowed but must have been discontinued at least 2 months before study drug is administered, and the patient must have recovered from acute toxic effects
Radiation therapy completed at least 7 days prior to start of study treatment and patients must have recovered from any acute adverse effects.
Patients must have recovered from the toxic effects of prior therapies
Patients must have fully recovered from major surgery and from the acute toxic effects of prior chemotherapy and radiotherapy (residual grade 1 toxicity, e.g. grade 1 peripheral neuropathy, and residual alopecia are allowed)
Have discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture prior to randomization and recovered from the acute effects of therapy
Patients must have been off therapy for MDS for 2 weeks prior to entering this study, and must have recovered from the toxic effects of that therapy to at least grade 1, unless there is evidence of rapidly progressive disease; use of hydroxyurea (any dose) or cytarabine (ara-C) (up to 1 g/m^2 x 2 doses) for patients with rapidly proliferative disease is allowed before the start of study therapy; these should be stopped for 24 hours prior to the initiation of azacitidine and sorafenib
Resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (Parts 1A and 1B) and/or recovered from major surgery or radiation therapy
Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (treatment related toxicity resolved to baseline) except for residual alopecia.
Failure to have fully recovered (i.e., =< grade 1 toxicity) from the reversible effects of prior chemotherapy
Patients who have not recovered from symptomatic side effects of radiotherapy at the time of initiation of screening procedure.
Prior systemic therapy within 14 days of study enrollment; patients must be adequately recovered from prior systemic therapy side effects as deemed by the treating investigator
Recovered from acute toxic effects of all prior chemotherapy at least one week and 30 days from prior chemotherapy before entering this study
Subjects must have recovered from the toxic effects of prior therapy; residual toxicity from any previous treatment must be =< Grade 1
Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
Has not recovered to ? Grade 1 from toxic effects of previous therapy and/or complications from previous surgical intervention before starting study therapy.
Patient is currently receiving or has received systemic corticosteroids =< 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment
Patients who have received radiotherapy =< 4 weeks prior to registration, with the exception of palliative radiotherapy, who have not recovered from side effects of such therapy to baseline or grade =< 1 are not eligible for participation\r\n* Note: any lesions treated with radiation therapy cannot be used in disease assessment
Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior system anticancer therapy, radiotherapy or surgery.
Recovered from toxic effects attributed to UC-961 to grade 1 levels, or baseline
Patient has not recovered to grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy
Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy.
Failure to have fully recovered (ie, =< grade 1 toxicity) from the reversible effects of prior chemotherapy
Participant has not recovered from the acute toxic effects of prior anticancer therapy, radiation, or major surgery/significant trauma.
Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
Patients must have recovered from side effects from prior cancer-directed therapy to grade 1 or less (unless deemed not clinically significant by study investigator)
Treatment with any investigational agent within 28 days prior to registration for protocol therapy and the subject must have recovered from the acute toxic effects of the regimen.
Participants must have recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy (including but not limited to exceptions of alopecia, laboratory values listed per inclusion criteria, and lymphopenia which is common after therapy with temozolomide)
Failure to fully recover from side effects of prior therapy or surgery
Patient who has received wide field radiotherapy =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug or who have not recovered to grade 1 or better from related side effects of such therapy (except alopecia)
Patient who has not recovered to grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy
History of prior malignancy, except for conditions as listed in the protocol if patients have recovered from the acute side effects incurred as a result of previous therapy
Failure to recover to grade =< 1 from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
Failure to recover from the reversible effects of prior anticancer therapies with the exception of alopecia, and after-effects associated with prior tyrosine kinase inhibitor therapy such as hair depigmentation, hypothyroidism, and/or splinter hemorrhage.
Patients must have recovered from toxicity of prior therapy
Failure to have fully recovered (ie, =< grade 1 toxicity) from the reversible effects of prior chemotherapy
Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy
Subjects may have been previously treated for a plexiform neurofibroma or other tumor/malignancy, but must have fully recovered from the acute toxic effects of all prior chemotherapy or radiotherapy prior to entering this study
Subjects must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer. (For example, subjects with residual Grade 1 toxicity or stable Grade 2 peripheral neuropathy due to prior chemotherapy are allowed with approval of the Medical Monitor.)
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 who have received radiotherapy =< 4 weeks prior to registration, with the exception of palliative radiotherapy, who have not recovered from side effects of such therapy to baseline or grade =< 1 and/or from whom >= 30% of the bone marrow was irradiated are not eligible for participation
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy (toxicity < grade 2)
Radiotherapy within 14 days of study treatment; patient must have recovered from acute effects of radiotherapy to baseline.
The patient has not recovered from the acute toxic effects of prior chemotherapy, radiation, or major surgery/significant trauma.
Subjects must have fully recovered from the acute toxic effects of all previous chemotherapy, immunotherapy, or radiotherapy treatment before enrollment.
Resolved acute effects of prior therapy
Participants must have fully recovered from the acute toxic effects of all prior anti-cancer therapy
Resolution of all acute toxic effects of prior therapy or surgical procedure to Grade <= 1 or baseline prior to randomization
Failed to have recovered from the reversible effects of previous anticancer therapies
Fully recovered from acute toxic effects of any prior chemotherapy, biological modifiers or radiotherapy
At the time of registration, patient must have recovered from the toxic effects of prior therapy to no more than grade 1 toxicity
No acute toxic effects from previous treatment superior to grade 1 at the start of the study
Patients must have recovered from any reversible effects of prior therapies to no more than grade 1 toxicity, with the exception of alopecia
The patient must have recovered from the effects of surgery, post-operative infection, and other complications before study registration.
Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
Must have recovered from acute toxicity from prior treatment
Patients must have recovered from the toxic effects of all prior therapy before entering this study
Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study; no chemotherapy or radiotherapy may be given within 2 weeks prior to the start of protocol treatment
Patients must have recovered from all prior therapy
Patients must have been off chemotherapy for 2 weeks prior to entering this study, unless there is evidence of rapidly progressive disease, and must have recovered from the toxic effects of that therapy to at least grade 1. Use of hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy.
Discontinued all prior cancer treatments for cancer & recovered from the acute effects of therapy
Failure to have fully recovered (ie, Grade 1 toxicity) from the effects of prior chemotherapy (except for alopecia) regardless of the interval since last treatment.
No prior therapy for recurrent ALL is allowed prior to study entry with the exception of intrathecal (IT) chemotherapy; participants who have relapsed while receiving up-front therapy are eligible, but must have recovered from adverse effects from any previously administered agents
The patient has recovered from reversible toxicity from prior therapy. Permanent and stable side effects or changes are acceptable if ? Grade 1 (CTCAE, v4.03)
Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiation therapy prior to entry on study; patients must have had at least one prior treatment regimen; patients may have received treatment previously with cyclophosphamide topotecan or bevacizumab
Patients who have not recovered from the toxic effects of prior chemotherapy and/or radiation therapy will be excluded; guidelines for this recovery period are dependent upon the specific therapeutic agent being used:\r\n* Patients may not have received chemotherapy or bevacizumab =< 4 weeks (except for nitrosourea [6 weeks] or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide [1 week]) prior to starting the study drug unless patients have recovered from side effects of such therapy\r\n* Patients may not have received immunotherapy =< 4 weeks prior to starting the study drug unless patients have recovered from side effects of such therapy\r\n* Patients may not be less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation\r\n* Patients must have completed all standard of care treatments, including surgical procedure, and radiation therapy (at least 59 Gy)\r\n** If the MGMT promoter in their tumor is known to be unmethylated, patients are not mandated to have received chemotherapy prior to participating in this trial\r\n** If the MGMT promoter in their tumor is known to be methylated or the MGMT promoter status is unknown at the time of screening, patients must have received at least one chemotherapy regimen prior to participating in this trial
Recovered (i.e., < grade 1 toxicity) from the reversible effects of prior antineoplastic therapy
Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) with the exception of fulvestrant (for Part G only) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (treatment related toxicity resolved to baseline) except for residual alopecia
No expectation of further effects of prior anticancer therapy
Resolution of all acute toxic effects of any prior treatments to NCI CTC (Version 3.0) grade <=1
Recovered from effects of recent surgery, radiotherapy, or chemotherapy
Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy in the month prior to treatment and must have recovered from all side effects of therapeutic and diagnostic interventions
Participants must have recovered from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery.
Resolution of (non-laboratory) adverse effects of recent surgery, radiotherapy, or chemotherapy to grade =< 1 prior to first study treatment (with the exception of alopecia or neuropathy)
The patient is, in the investigator's opinion, adequately recovered from the effects of surgery and chemoradiotherapy to participate in this study.
Failure to have fully recovered from the reversible effects of prior anti-cancer therapy
Resolution of all acute toxic effects of any prior treatments to NCI CTC (Version 3.0) grade <=1
Patients may be treated on this trial without having received prior therapy; if patients have received prior therapy, they must have recovered from all toxic effects prior to entering this study
Subjects who have not recovered from the effects of recent surgery
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiation therapy prior to entering this study
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
Resolution to Grade ? 1 Adverse Events, of all clinically significant toxic effects of prior therapy
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
Recovered from all toxic effects (excluding alopecia) of any prior anti-cancer therapy to Grade ? 1 or to the baseline laboratory values.
Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy, up to CTCAE grade 1
Failure to have fully recovered (i.e., =< grade 1 toxicity) from the reversible effects of prior chemotherapy, radiation therapy or targeted therapy
Has recovered (ie, <= Grade 1 toxicity or eligibility per this protocol is met) from the reversible effects of prior anticancer therapy.
Chemotherapy < 2 weeks prior to starting study drug with the following exception: There is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such
Failure to have fully recovered (ie, =< grade 1 toxicity) from the reversible effects of prior chemotherapy
Failure to have fully recovered (i.e., =< grade 1 toxicity) from the reversible effects of prior chemotherapy
are recovered from the acute adverse effects of prior therapies (excluding alopecia and Grade ?2 neuropathy).
Patients must have received prior therapy other than surgery and must have fully recovered from the acute treatment related toxicities of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Prior therapy: \r\n* The patient’s malignancy must have relapsed after or failed to respond to frontline curative therapy and/or there must not be any potentially curative treatment options available at the time of study entry\r\n* There is no limit to the number of prior treatment regimens; however, patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study enrollment; acute toxicity of any previous therapy must have resolved to grade 1 or less, unless specified elsewhere
Received radiation (including therapeutic radioisotopes such as strontium 89) therapy ? 3 months prior to the first dose of study treatment and have not recovered from side effects of such therapy (? Grade 1) prior to the first dose of study treatment, except for alopecia.
Patient has not recovered to ? grade 1 (except alopecia) from related side effects of any prior antineoplastic therapy
Recovered (=< grade 1 toxicity) from the reversible effects of prior antineoplastic therapy
Patient must have recovered sufficiently from any adverse effects of neoadjuvant treatment
Patient must have recovered sufficiently from any adverse effects of neoadjuvant treatment
Patients must have recovered from the toxic effects of all prior chemotherapy before entering this study
The patient must have discontinued all previous therapies for acute leukemia for at least 14 days and recovered from the acute non-hematologic side effects of the therapy
Participants must have fully recovered from the acute toxic effects of all prior therapy prior to first administration of study drug
Patients must be recovered from acute and late effects of any prior surgery, radiotherapy or other anti-neoplastic therapy
Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy or surgery
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients must have received a minimum of 54 Gy focal irradiation administered over approximately 42 days prior to enrollment; patients must have recovered from the acute treatment-related toxicities (defined as =< grade 1) of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Has not recovered from toxic effect of prior therapy to < Grade 1.
Resolution of adverse effects of recent surgery, radiotherapy, or chemotherapy to grade =< 1 prior to first study treatment (with the exception of alopecia or neuropathy)
Patients must have recovered from the effects of prior surgery.
Have discontinued all previous cancer therapies and any agents that have not received regulatory approval for any indication, for at least 21 days or 5 halflives prior to study enrollment, whichever is shorter, and recovered from the acute effects for therapy.
Resolution of all acute toxic effects of prior chemotherapy, and other cancer treatments
Recovered from the effects of any prior systemic therapy, radiotherapy or surgery
Patients must have fully recovered from the acute toxic effects of all prior anticancer chemotherapy
Must have recovered from all side effects of their most recent systemic or local treatment
PRIOR THERAPY Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
Patients must have recovered from side effects from prior cancer-directed therapy to grade 1 or less (unless deemed not clinically significant by study investigator)
Participants who have not recovered from any reversible side effects (except alopecia) to Grade 0 or 1 toxicity attributed to the administration of an investigational therapeutic agent, chemotherapy, immunotherapy, radiotherapy, or other agents previously used to treat the cancer.
Patients who have not recovered from symptomatic side effects of radiotherapy at the time of initiation of screening procedure.
Subject has not fully recovered from the acute toxicities (except alopecia) of any prior anti-cancer therapy.
Recovered (i.e., Grade ? 1 or to a baseline level) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other therapies for cancer (with the exception of alopecia for which no resolution is required and peripheral neuropathy which must have resolved to Grade ? 1 for subjects receiving prior taxane-based chemotherapy);
Patient has not recovered from the acute toxic effects of prior anticancer therapy, radiation, or major surgery/significant trauma.
Systemic treatments: Must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. Participants must have discontinued:
Recovered from the reversible effects of prior antineoplastic therapy (ie, ? Grade 1 toxicity or baseline).
Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. Myelosuppressive Chemotherapy:
Recovered (that is, less than or equal to (<=) Grade 1 toxicity) from the effects of prior antineoplastic therapy.
Use of an investigational agent that is not expected to be cleared by the time of first dose of study drug or that has been demonstrated to have prolonged side effects. Patients must have recovered from all side effects to a Grade 0 or 1 (except alopecia and neuropathy).
Have discontinued previous treatments for cancer and recovered from all acute toxic effects of prior systemic therapy (except alopecia) to grade ?1;
Resolution of acute toxic effects of prior chemotherapy and other cancer treatments
Recovered from effects of recent surgery, radiotherapy, and chemotherapy
Recovery from the toxic effects of prior therapy to not more than grade 1 or > 3 weeks from prior therapy to registration, whichever is later
Patients must have fully recovered from any effects of major surgery, and be free of significant detectable infection
Patients must be recovered from the effects of any prior surgery, radiotherapy, or other antineoplastic therapy
Acute toxic effects of previous anticancer chemotherapy or immunotherapy have to be normalized to CTCAE Grade equal or lower than 1 (excluding alopecia)
Failure to fully recover from acute, reversible effects of prior surgery or chemotherapy regardless of interval since last treatment
Recovered from the effects of prior antineoplastic therapy
Patients must have recovered from all acute adverse effects (excluding alopecia) of prior therapies to baseline or <= grade 1 prior to study entry.
Failure to have recovered from clinically significant effects of prior chemotherapy (defined as toxicity greater than Grade 1 with the exception of alopecia)
Patients who have received definitive radiotherapy ? 4 weeks prior to starting study drug, who have not recovered from side effects of such therapy and/or from whom ? 30% of the bone marrow was irradiated.
Recovered (i.e., =< grade 1 toxicity) from the reversible effects of prior antineoplastic therapy
Patients who have received targeted therapy (e.g. sunitinib, sorafenib, pazopanib) =< 1 week prior to starting study drug, or who have not recovered from the side effects of such therapy
Patients must have fully recovered from the acute toxic effects of all previous chemotherapy, immunotherapy, or radiotherapy prior to study enrollment.
Has not recovered to ? Grade 1 from toxic effects of prior therapy.
Patients must have been off all prior therapy for leukemia except hydroxyurea for 1 week prior to entering this study and recovered from the toxic effects of that therapy
Recovered or stabilized from prior treatments.
Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy. Up to CTCAE Grade 1 is acceptable for patients with known peripheral neuropathy
Patients must have recovered from any previous therapy side effects or toxicities prior to initiating protocol study infusions.
Participants must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Patients must have recovered from toxicity of prior therapy
Discontinued all previous cancer therapies, and any agents that have not received regulatory approval, for at least 21 days and recovered from the acute effects of therapy. Must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days.
Patient has received other investigational drugs within 14 days before enrollment or who have not recovered from side effects of those therapies
Resolution to Grade ? 1 Adverse Events, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (except alopecia)
All patients must be off previous chemo- and/or radiotherapy for at least three (3) weeks prior to entrance into the study and have recovered from any toxic effects induced by such treatment(s). Patients who have received a nitrosourea type drug must have had no treatment within the last six weeks.
Prior cancer treatment must be completed at least 14 days prior to registration for protocol therapy and the patient must have recovered from the acute toxic effects of the regimen. With the exception of Bevacizumab treatment, which must be completed 30 days prior to registration for protocol therapy.
Prior/Concurrent Therapy: Research participants must have recovered from the acute effects of prior treatment and:
Patient has not recovered from clinical and laboratory acute toxicities of chemotherapy, radiotherapy and surgery
Previous chemotherapy, and/or biological therapy for cancer are permitted provided that the acoustic properties of the tumor were not affected, but the subject should have recovered from the effects of these or of any prior surgery
Received the last administration of an anticancer monoclonal antibody, immunotherapy, hormonal therapy, or chemotherapy (except nitrosoureas and mitomycin-C) =< 28 days prior to study registration or who have not recovered from the side effects of such therapy
Received the last administration of nitrosourea or mitomycin-C =< 42 days prior to study registration, or who have not recovered from the side effects of such therapy
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study; at least 14 days must have elapsed from prior chemotherapy; at least 7 days must have elapsed since receiving biological therapy
Have not recovered from the adverse effects or toxicities of lymphoma therapy most recently administered
Patients must have fully recovered from the acute effects of all prior therapy
Recovered (that is, <= Grade 1 toxicity) from the reversible effects of prior anticancer therapy.
Patients having undergone recent resection (within 5 weeks prior to registration) of their glioblastoma to treat current recurrence prior to study treatment must have recovered from the effects of surgery (including patient's skin having fully recovered from the surgical wound) Note: a 4-week window is required after surgery prior to starting treatment. For CNS-related stereotactic biopsies, a minimum of 7 days must have elapsed prior to registration.
Patients must have recovered from the toxic effects of prior therapy at the time of registration as follows:
Participants who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from gastrointestinal (GI) adverse events due to induction therapy; patients who have had localized radiation which would not result in any GI effects are allowed on study
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy prior to entering study; three (3) weeks must have elapsed since the administration of prior chemotherapy
Patients must have completed mastectomy or breast-sparing surgery and must have recovered from all side effects of the surgery; if patients were treated with chemotherapy and/or radiation therapy, these treatments must be completed at least 28 days prior to study registration; patients should have recovered from all grade 2 or higher side effects of chemotherapy and/or radiation therapy with the exception of alopecia and peripheral neuropathy; concurrent bisphosphonate and trastuzumab therapies are allowed
Recovered from the effects of any prior surgery or radiotherapy
Diseases refractory/relapsed after one or more systemic cytotoxic therapies; patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
Recovered from the reversible effects of prior antineoplastic therapy (with the exception of alopecia and Grade 1 neuropathy).
Resolution of all clinically significant toxic effects of prior therapy.
Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from hematological and bone marrow suppression effects of prior chemotherapy.
Patient has recovered from the toxic effects of prior therapy, and is at least 30 days from the most recent cytotoxic therapy, prior to enrollment
Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the effects of prior chemotherapy (hematological and bone marrow suppression effects).
Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the effects of prior chemotherapy (hematological and bone marrow suppression effects).
At the time of registration, subjects must have recovered from the toxic effects of previous treatments, as determined by the treating physician.
Patients who have received prior adjuvant high dose interferon are allowed to participate as long as the last injection was given at least 30 days prior to the C11-AMT PET scan and they have fully recovered from side effects (i.e., grade =< 1 or permanent side effects that require hormone replacement therapy)
Patient must have fully recovered from the acute toxic effects of all prior chemotherapy or radiation prior to entering this study
Failure to have fully recovered (ie, =< grade 1 toxicity) from the reversible effects of prior chemotherapy
Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, cancer-related hormonetherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug and have recovered from the acute effects of therapy(treatment related toxicity resolved to baseline), except for residual alopecia
Recovered (that is, grade less than or equal to [<=] 1 toxicity) from the reversible effects of prior anticancer therapy.
Recovered (that is, less than or equal to [<=] Grade 1 toxicity) from the reversible effects of prior anticancer therapy.
Prior therapy: Must have recovered from acute toxic effects of prior anti-cancer therapy (durations relative to date of enrollment):
Recovered (that is, less than or equal to (<=) Grade 1 toxicity) from the effects of prior antineoplastic therapy.
Patients must have completed all previous anticancer therapy for at least 2 weeks prior to the first planned dose of omacetaxine, except as noted below, and must have fully recovered from side effects of a previous therapy.
Has not recovered to ? Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy.
Recovered (that is, <=Grade 1 toxicity) from the reversible effects of prior anticancer therapy.
Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.
Has not recovered to ? Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting therapy