Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of trametinib and during the study
Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to randomization
From the projected start of scheduled study treatment, the following time periods must have elapsed: 5 half-lives from investigational agents, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 6 weeks from antibodies, or 4 weeks (or 5 half-lives, whichever is shorter) from other systemic anti-tumor therapies; treatment on study may start one day after discontinuation of the optune device
At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior chemotherapy or small molecule targeted therapy
Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug. Topical ketoconazole will be allowed.
Prior anticancer treatment within 28 days (or 5 times the half-life time, whichever is shorter) or any investigational agent within 30 days prior to the first dose of study drugs. All acute toxicities related to prior treatments must be resolved to Grade less than or equal to 1
Inclusion Criteria:\n\n        For CML patients either:\n\n          -  a. Patients with Ph+ CML in chronic or accelerated phase who were previously treated\n             with at least two different tyrosine kinase inhibitors prior to study entry and are\n             relapsed, refractory to or intolerant of TKIs as determined by investigators or\n\n          -  b. Patients with CML in chronic or accelerated phase who exhibit relapsed disease\n             associated with the presence of the T315I \gatekeeper mutation\ after at least one TKI\n             are also eligible provided that no other effective therapy exists\n\n        For ALL and CML-BP patients:\n\n          -  Patients with CML BP or Ph+ ALL who have a cytopathologically confirmed diagnosis and\n             are relapsed or refractory to at least one prior TKI or intolerant of TKIs. TKI\n             failure for Ph+ ALL and CML-BP patients is defined as at least the loss of Molecular\n             Response (MR) 4.5 (BCR-ABL ? 0.0032%)\n\n          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2\n\n          -  Willingness and ability to comply with all study procedures\n\n          -  Written informed consent obtained prior to any screening procedures\n\n        Exclusion Criteria:\n\n        Wash-out period:\n\n          -  Systemic antineoplastic therapy (including cytotoxic chemotherapy, alfa-interferon and\n             toxin immunoconjugates) or any experimental therapy within 14 days or 5 half-lives,\n             whichever is shorter, before the first dose of study treatment\n\n          -  Therapy with TKIs as single agent within 5 half-lives before the first dose of study\n             treatment\n\n          -  Unconjugated monoclonal antibody therapies within 28 days or 5 half-lives, whichever\n             is shorter, before the first dose of study treatment\n\n          -  For patients receiving ABL001 in combination with either nilotinib or imatinib or\n             dasatinib, intolerance to nilotinib, imatinib or dasatinib, respectivelyRadiotherapy\n             with a wide field of radiation within 4 weeks or radiotherapy with a limited field of\n             radiation for palliation within 1 week of the first dose of study treatment.\n\n          -  CNS irradiation for meningeal leukemia, except if radiotherapy occurred > 3 months\n             previously. At least four weeks must have elapsed since prophylactic CNS irradiation\n             given as part of a front-line therapy regimen for ALL\n\n          -  Major surgery within 2 weeks before the first dose of study treatment\n\n        Other protocol-defined inclusion/exclusion criteria may apply
Women of childbearing potential and men must use adequate contraception prior to study entry and for the duration of study participation; contraception should continue to be used for a minimum of 5 mean half-lives after the last dose of study drugs (mean trastuzumab half-life at 6 mg/kg 16 days; mean half-life ruxolitinib: 3 hours)
Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart), or any herbal product known to decrease PSA levels (e.g., saw palmetto and PC-SPES), or any systemic corticosteroid within 2 weeks prior to first dose of study drug; if the medication has a known half life such that 5 half lives is less < 2 weeks, this 5 half-life wash out is acceptable
Male subjects who are unwilling to use contraception during the treatment and for at least 31 weeks after the last dose of study treatment (5 half-lives of study drug plus 90 days duration of sperm turnover).
Ongoing or recent use of a checkpoint inhibitor agent (eg ipilimumab, pembrolizumab, nivolumab) within three drug half-lives from the most recent dose to Cycle 1 Day 1
Monoclonal antibody treatment and agents with known prolonged half-lives: At least three half-lives must have elapsed prior to enrollment.\r\n* Note: a list of the half-lives of commonly used monoclonal antibodies is available on the Pediatric Brain Tumor Consortium (PBTC) webpage under Generic Forms and Templates
Patients who have received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational agents within 14 days or five half-lives, whichever is greater (with exception of hydroxyurea), prior to drug administration on this study.
Prior treatment with systemic immunotherapeutic agents within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first infusion
Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first BFCR4350A infusion
Less than 30 days since last dose of anti CD38 therapy or less than 5 half-lives since last dose of previous systemic therapy.
Subjects must have been off any prior TKIs for at least 5 half-lives of that drug, or any prior chemotherapy for at least 4 weeks prior to study enrollment
Oral targeted therapy within 5 half-lives (if known) or 3 weeks (if half-life is unknown) of study entry
Any non-chemotherapy anti-cancer drug less than 5 half-lives (30 days for biologics) or less than 14 days for small molecule therapeutics, or if half-life is not known.
Any investigational drug therapy within 5 half-lives of the previous investigational study drug or 30 days, whichever is shorter.
Received treatment, within 28 days or 5 half-lives, whichever is shorter, prior to the first scheduled day of dosing, with any investigational agents that have not received regulatory approval for any indication or disease state and all prior clinically significant treatment related toxicities have resolved to Grade 1 or baseline
Administration of any antineoplastic therapy within 5 half-lives of the antineoplastic therapy before the first dose of ORH-2014, with the exception of hydroxyurea that should be discontinued 1 day prior to the first dose of ORH-2014
Less than or equal to 5 half lives or 4 weeks, whichever is shorter, from the use of any investigational therapy prior to registration
Patients who have had tyrosine kinase inhibitor therapy (e.g.: ibrutinib or idelalisib) within 7 half lives (or 28 days, whichever is shorter) of initiation of DMF
Patients who were treated with chemotherapy, radiotherapy, immunotherapy or any investigational therapies, if eligible, must have been completed at least 4 weeks or at least 5 half-lives (whichever is shorter, but no less than 3 weeks) before the study drug administration, and all AEs have either returned to baseline or stabilized. Prior therapies targeting PD-1, programmed death-ligand 1 (PD-L1), or PARP is exclusionary (See Exclusion Criterion 5).
Use of any approved tyrosine kinase inhibitors within 2 weeks or 6 half-lives of the agent, whichever is shorter, prior to study registration
At least three half-lives must have elapsed prior to registration; such patients should be discussed with the study chair prior to registration
Use of other investigational drugs within 28 days or at least 5 half-lives (whichever is shorter) before study drug administration
No other systemic therapies for prostate cancer within 28 days or 5 half-lives, whichever is shorter, prior to day 1 of study therapy
Use of an investigational drug within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of TGR-1202; for investigational drugs for which 5 half-lives is less than 21 days, a minimum of 10 days between termination of the investigational drug and administration of TGR-1202 is required
Patients who are receiving any other investigational agents within 4 weeks or 5 half-lives (whichever is later) prior to the first dose of the study regimen
Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy (including prednisone ? 40 mg/day or equivalent) within 14 days or 5 half-lives (whichever is shorter) prior to Cycle 1, Day 1 treatment.
Patient has received other investigational drugs with 21 days before enrollment (or must be > than four half-lives of the experimental agent); no prior SAR650984 anti-CD38 antibody therapy allowed
Taken an investigational drug within 28 days or 5 half-lives (minimum 14 days), whichever is shorter, prior to study day 1
Non-cytotoxic therapy less than or equal to 5 half-lives prior to registration
Patient has received other investigational drugs within 21 days prior to cycle 1, day 1; exceptions allowed if greater than four half-lives of the experimental agent)
Patients who are receiving any other investigational agents have received any other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study treatment and during the study
Patients who have had prior monoclonal antibody therapy must have completed that therapy >= 6 weeks (or 3 half-lives of the antibody, whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment)
Have received treatment with an investigational small molecule less than 2 weeks before the first dose of AG-270. In addition, the first dose of AG-270 should not occur before a period greater than or equal to 5 half-lives of the investigational small molecule has elapsed.
Last dose of prior anti-tumor therapy <21 days prior to the first administration of idasanutlin or <5 times terminal half-life of that therapy, whichever is shorter
Targeted therapy, including monoclonal antibodies and immuno-oncology therapies: 4 weeks or 5 half-lives, whichever is shortest
Hormonal therapy: 4 weeks or 5 half-lives, whichever is shortest
Experimental therapy: 4 weeks or 5 half-lives, whichever is shortest
Discontinuation of previous cancer therapies at least three (3) weeks or 5 half-lives, whichever is shorter.
Use of other investigational agents within 30 days or 5 half-lives prior to the first dose of study drug. As long as patient has recovered from any related toxicities ? Grade 1.
At least 3 weeks or 5 half-lives, whichever is shorter, should have elapsed since prior treatment as long as the patient recovered from any related toxicities to ? Grade 1.
The disease should be progressing/relapsed during or after the previous treatment. At least 3 weeks should have elapsed since prior chemotherapy or 5 half-lives, whichever is shorter, as long as the patient recovered from any related toxicities to ? Grade 1.
Must have received at least one line of chemotherapy and no other standard therapy with proven clinical benefit is available. At least 3 weeks should have Elapsed since prior chemotherapy or 5 half-lives, whichever is shorter, as long as the patient recovered from acute toxicity of previous therapies to ? grade 1.
The disease should be progressing/relapsed during or after the previous treatment. At least 3 weeks should have elapsed since prior chemotherapy or 5 half-lives, whichever is shorter, as long as the patient recovered from acute toxicity of previous therapies to ? Grade 1.
Received any other investigational agents within 4 weeks prior to enrollment, or < 5 half-lives since completion of previous investigational therapy, whichever is shorter
Received previous non-cytotoxic, FDA-approved anticancer agent within previous 2 weeks, or < 5 half-lives since completion of previous therapy, whichever is shorter
Anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks or 5 half lives, whichever is shorter, prior to initiation of study treatment
The subject should be off any anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic or any investigational agents for at least 14 days or 5 half lives, whichever is greater, prior to enrollment with the exception of hydroxyurea. All prior treatment-related non-hematologic toxicities must have resolved to ? grade 2 prior to screening.
anti-cancer treatments (including cytotoxic chemotherapy, radiotherapy, hormonal therapy, biologic, immunotherapy or investigational drugs) received within 14 days or 5 half-lives for targeted therapies (whichever is shorter) before first dose of study drug (to be supplemented)
If patient received any previous systemic therapy, the last dose must have been ? 21 days prior to randomization (or ? 5 half-lives of that drug - whichever is shorter) with all clinically significant therapy- related toxicities having resolved to less than or equal to Grade 1
Use of anti-cancer treatment drug =< 21 days or 5 half-lives (whichever is shorter) prior to the first dose of AZD1775; for drugs for which 5 half-lives is =< 21 days, a minimum of 10 days between termination of the prior treatment and administration of AZD1775 treatment is required
Concurrent anticancer treatment, major surgery or use of any investigational drug within 28 days or 5 half-lives, whichever is shorter, before the start of trial treatment; palliative radiation therapy is allowed if > 21 days before planned first dose of study drugs and any toxicity is ? Grade 1.
Treatment with systemic immunostimulatory agents (including but not limited to interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to cycle 1, day 1
Prior systemic standard or investigational anticancer therapy, including target therapy, chemotherapy, immunotherapy within 28 days prior to the first dose of study drug. The above mentioned conditions which the Investigator considers there is no more drug effect, such as ?5 half-lives are permitted
experimental agents within 3 half-lives prior to enrollment, unless progression is documented on therapy
Any small molecule, biologic, or hormonal agent within 21 days or a washout period equal to 5 half-lives (whichever is shorter). At least 7 days must have elapsed between the last dose of such agent and the first dose of study drug.
Patients who have received prior systemic anti-cancer treatment within 4 weeks or 5 half-lives of prior to starting study treatment, whichever is shorter
Oral or IV antibiotics within 2 weeks or 5 half-lives prior to enrollment
Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrollment
Treatment with systemic corticosteroids or other systemic immunosuppressive medications within past 4 weeks or 5 half-lives whichever is shorter
Has received other investigational agents within 4 weeks or 5 half-lives of planned first dose of study agents
At the time of treatment, patients should be off other anti-tumor agents for at least 5 half-lives of the agent or 3 weeks from the last day of treatment, whichever is shorter to enroll in group 3; patients must not have been treated with anti-tumor agents to enroll in group 1 or group 2; patients must be off prior antibody therapy for at least 3 half-lives before starting treatment; patients may enroll on study even while receiving treatment
Current treatment with any agent known to cause Torsades de Pointes which cannot be discontinued at least five half-lives or two weeks prior to the first dose of study treatment.
Receiving other investigational drugs or biologics within 1 month or five half-lives. Cytotoxic or biologic are not permitted throughout the study.
Prior systemic cancer-directed treatments or investigational modalities ? 5 half lives or 4 weeks prior to starting CC-90002, whichever is shorter.
Biologic or investigational agent (anti-neoplastic): Patient must have received their last dose of the investigational or biologic agent >= 7 days prior to study enrollment \r\n* For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration must be discussed with and approved by the study chair\r\n* Monoclonal antibody treatment and/or agents with prolonged half-lives: at least three half-lives must have elapsed prior to enrollment
INCLUSION CRITERIA FOR STRATUM C: Patient must have received their last dose of the investigational or biologic agent >= 7 days prior to study enrollment\r\n* For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration must be discussed with and approved by the study chair\r\n* Monoclonal antibody treatment and/or agents with prolonged half-lives: at least three half-lives must have elapsed prior to enrollment
The time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drugs is < 5 times the half-life of the previously administered agent(s).
Treatment with systemic immunostimulatory agents (including but not limited to interferons or Interlukin-2 [IL-2]) within 4 weeks or five half-lives of the drug (whichever is shorter) prior to randomization
Prior antineoplastic antibody therapy within 5 half-lives or 1 week prior to apheresis, whichever is greater
Must have discontinued cancer treatments, including experimental agents for 28 days or a minimum of 5 half-lives (for any biologics) prior to the start of treatment. Enrollment after exposure levels of a biologic have fallen below an active level as established in the summary basis of approval is acceptable.
No antibodies within 3 half-lives prior to study enrollment (applicable to phase 1 only)
Use of an investigational drug ?21 days or 5 half-lives (whichever is shorter) prior to the first dose of orteronel, or concurrent treatment. For investigational drugs for which 5 half-lives is less than 21 days, a minimum of 10 days between termination of the investigational drug and administration of orteronel is required.
Patients must have completed any chemotherapy, radiation therapy, surgery, or biologic therapy >= 3 weeks (or >= 5 half-lives, whichever is shorter) prior to entering the study; patients must be >= 2 weeks since any prior administration of a study drug in an exploratory investigational new drug (IND)/phase 0 study or >= 1 week from palliative radiation therapy; patients must have recovered to eligibility levels from prior toxicity or adverse events
Have discontinued all previous cancer therapies (except nonsteroidal aromatase inhibitors for participants in Part B2), and any agents that have not received regulatory approval for any indication, for at least 21 days or 5 half lives prior to study enrollment, whichever is shorter, and recovered from the acute effects of therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days
Treatment with systemic immunostimulatory agents (including but not limited to interferons or IL-2) within 4 weeks or five half-lives of the drug, whichever is shorter, from cycle 1 day 1.
Prior chemotherapy: Patients should be at least 30 days from last chemotherapy dose prior to start of CED infusion, with exception of antibody half-lives. For antibody therapies, at least 3 half-lives of the antibody after last dose of monoclonal antibody should have passed prior to CED infusion
Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of the study drug (s) plus 90 days (duration of sperm turnover); the half-lives of nivolumab and ipilimumab are up to 25 days and 18 days, respectively; men should therefore use an adequate method of contraception for a total of 31 weeks posttreatment completion
Patients who have had chemotherapy or radiotherapy within 4 weeks or five half-lives whichever is shorter (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
Treatment with any investigational drug within 28 days or 5 half-lives of day 1 of treatment on this study.
Treatment with a monoclonal antibody within 28 days or 5 half-lives, whichever is shorter, from treatment with first dose of study drug
Patients must not have received any investigational agents within 30 days of study entry unless they have exceeded 5 terminal half-lives of the previous study drug used for treatment
Patient receiving anticancer therapy (e.g. chemotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) ?3 weeks or 5 half-lives (whichever is shorter) prior to C1D1,
Subject has received anticancer therapies including chemotherapy, radiotherapy or other investigational therapy, including targeted small molecule agents within 5 half-lives prior to first dose of study drug
Any drug interactions that are deemed to be medically significant would require a washout of 5-half-lives of the interaction agent before enrollment can occur
Prior monoclonal antibody therapy within 5 half-lives or 7 days prior to apheresis, whichever is greater
Treatment with an investigational drug within 5 half-lives of the compound
From the projected start of scheduled study treatment, the following time periods must have elapsed: 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 6 weeks from antibodies, or 4 weeks (or 5 half-lives, whichever is shorter) from other anti-tumor therapies.
MEDICATION-RELATED: Treatment with systemic immunostimulatory agents (including but not limited to interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to cycle 1, day 1.
In the absence of rapidly progressive disease, the interval from prior treatment to the time of initiation of protocol therapy will be at least 14 days for prior anti-leukemic therapy, with the exception of hydrea, or at least 5 half-lives for cytotoxic/noncytotoxic agents, whichever is shorter. The half-life for the therapy in question will be based on published pharmacokinetic literature (abstracts, manuscripts, investigator brochures, or drug-administration manuals) and will be documented in the protocol eligibility document. The toxicity from prior therapy should have resolved to grade =<, however alopecia and sensory neuropathy grade =< 2 not constituting a safety risk based on investigators judgement is acceptable. Since the effect of most IO-agents, hypomethylating agents (HMA)-therapies, SMO-inhibitors may be delayed, use of hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and will not require a washout.
At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy prior to enrollment
PHASE II: At the time of enrollment, at least 6 weeks must have elapsed since the last dose of any nitrosourea, and the longer of 2 weeks or 3 half-lives must have elapsed since the last dose of any other tumor-directed medication, or biologic therapy
Use of an investigational drug within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of X-396. A minimum of 10 days between treatment and X-396 and 2 days between ALK TKI and X-396.
Patient must have received their last dose of the biologic agent >= 7 days prior to study registration\r\n* For biologic agents that have a prolonged half-life, at least three half-lives must have elapsed prior to registration
Monoclonal antibody treatment: at least three half-lives must have elapsed prior to registration
Patients who have had other investigational agents within 4 weeks or 5 half-lives, whichever is shorter, of the study enrollment
Treatment with systemic immunostimulatory agents (including but not limited to interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to start of study treatment.
Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. The investigator shall review contraception methods and the time period that contraception must be followed. Men who are sexually active with WOCBP must follow instructions for birth control when the half-life of the investigational drug is greater than 24 hours, contraception should be continued for a period of 90 days plus the time required for the investigational drug to undergo five half-lives. The half-life of nivolumab and ipilimumab is up to 25 days and 18 days, respectively. Therefore, men who are sexually active with WOCBP must continue contraception for 7 months (90 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug.
Use of other investigational, chemotherapeutic or targeted drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of talimogene laherparepvec and during the study are ineligible
From the projected start of scheduled study treatment, the following time periods must have elapsed: 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 6 weeks from antibodies, or 4 weeks (or 5 half-lives, whichever is shorter) from other anti-tumor therapies
Treatment with systemic immunostimulatory agents (including but not limited to interferon [IFN]-a or interleukin [IL]-2) within 4 weeks or five half-lives of the drug (whichever is shorter) prior to cycle 1, day 1
Patient has had any treatment specific for tumor control within 3 weeks of dosing, or for investigational drugs and cytotoxic agents, within 5 half-lives or 3 weeks, whichever is shorter
Patients who are receiving any other investigational agents. Patients who have taken an investigational drug within 28 days or 5 half-lives (minimum 14 days), whichever is shorter, prior to registration.
Experimental agents within 3 half-lives prior to enrollment, unless progression is documented on therapy
Treatment with any systemic anticancer treatment (including investigational products) within 30 days or 5 half-lives, whichever is shorter, before the first dose of study drug.
Must not have received monoclonal antibodies within at least 3 half-lives of the antibody after its last dose.
No antibodies within 3 half-lives prior to study enrollment
Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrollment (with the exception of checkpoint blockade therapy)
Treatment with systemic corticosteroids or other systemic immunosuppressive medications within past 4 weeks or 5 half-lives whichever is shorter
Current or prior use of anticancer therapy before TIL collection:\r\n* Chemotherapy within the past 4 weeks\r\n* Tyrosine kinase inhibitor (TKI) within the past 1 week\r\n* Investigational therapy within the past 4 weeks or 4 half-lives, whichever is shorter
Treatment with systemic immunostimulatory agents (including but not limited to interferon [IFN]-a or interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to study treatment
Patients who have received other investigational medication within the last 4 weeks or a period of its 5 half-lives (whichever is shorter) before the first OBP-301 administration.
experimental agents within 3 half-lives prior to enrollment, unless progression is documented on therapy
Current treatment with any agent known to cause Torsades de Pointes which cannot be discontinued at least five half-lives or two weeks prior to the first dose of study treatment.
(Atezolizumab-related exclusion) Treatment with systemic immunostimulatory agents (including but not limited to interferon [IFN]-(alpha) or interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to cycle 1, day 1
Receiving any investigational agent currently or within 28 days or 5 half-lives of day 1 of treatment on this study
Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrollment
Treatment with systemic immunostimulatory agents (including but not limited to IFNs, interleukin [IL]-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to cycle 1 day 1
Treatment with chemotherapy or other investigational agents within 28 days (or at least 5 x the half-life of the drug) prior to day 1 cycle 1 of Minnelide™ (6 weeks for nitrosoureas or Mitomycin C).
Treatment with systemic immuno-stimulatory agents (including but not limited to interferon [IFN] or interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to cycle 1, day 1
At least 3 weeks or 5 half-lives, whichever is shorter, since receiving systemic anticancer therapy, including investigational agents. At least 2 weeks since receiving radiation therapy
Patients should be at least 30 days from last chemotherapy dose prior to start of CED infusion, with exception of antibody half-lives; for antibody therapies, at least 3 half-lives of the antibody after last dose of monoclonal antibody should have passed prior to CED infusion
Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of trametinib and during the study
WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug plus 30 days (duration of ovulatory cycle); the half-life of nivolumab and ipilimumab is up to 25 days and 18 days, respectively; WOCBP should therefore use an adequate method to avoid pregnancy for a total of 23 weeks post-treatment completion
Subjects must be >=4 weeks beyond treatment with any chemotherapy or other investigational therapy to include hormonal, biological, or targeted agents; or at least 5 half-lives from hormonal, biological, or targeted agents, whichever is shorter at the time of treatment initiation.
Currently receiving or have received any other investigational agent considered as a treatment for the primary neoplasm =< 28 days or within 4 half-lives (whichever is shorter) of the agent prior to registration
Received any of the following prior anticancer therapy:\r\n* Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy (RIT), or intra-operative radiotherapy (IORT); Note: stereotactic radiosurgery (SRS) is allowed\r\n* Non-antiangiogenic therapy (including investigational agents and small molecular kinase inhibitors) within 7 days or 5 half-lives, whichever is shorter, prior to the first dose of study drug\r\n* Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug\r\n* Nitrosoureas or mitomycin C within 42 days or metronomic/protracted low- dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug\r\n* Prior treatment with TVB-2640\r\n* Prior treatment with Carmustine Wafers
Treatment with systemic immunostimulatory agents (including but not limited to interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to cycle 1, day 1
Previous (within 5 drug half-lives - if drug half-life in subjects is known - or 28 days, whichever is shorter, before the start of study treatment) or concomitant participation in another clinical study with investigational medicinal product(s) (IMP[s])
Experimental agents within 4 weeks of leukapheresis unless no response or disease progression is documented on the experimental therapy and at least 3 half-lives have elapsed prior to leukapheresis
From registration, the following time periods must have elapsed: 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 6 weeks from antibodies, or 4 weeks (or 5 half-lives, whichever is shorter) from other anti-tumor therapies (including vaccines); no wash-out period required from time to treatment failure (TTF)
Any systemic therapy, including monoclonal antibody within 28 days or 5 half-lives (whichever is shorter) of initiating protocol therapy
Investigational therapy, chemotherapy, immunotherapy, radiotherapy, or systemic graft versus host disease (GVHD) therapy within two weeks or five half-lives (whichever is shorter); steroids, hydroxyurea and/or leukapheresis are allowed to control blast count prior to the first dose of study drug
Prior chemotherapy within 21 days or 5 half-lives (whichever is shorter) before starting treatment
Prior therapy with investigational agent within 21 days or 5 half-lives (whichever is shorter) before starting treatment
WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational product; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; these durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days
Having received cancer-directed therapy (chemotherapy, radiotherapy, hormonal therapy, biologic or immunotherapy, etc) or an investigational drug within 4 weeks (6 weeks for mitomycin C and nitrosoureas) or 5 half-lives of that agent (whichever is shorter) before the first dose of study drug
Any investigational or anti-tumour treatment within 4 weeks or 5 half-life period (whichever is shorter)prior to the initial administration of BI 754091.
Patients who were receiving prior therapy will require wash out period of either more than 2 weeks or more than 5 half-lives whichever shorter
Prior treatment within the following timeframes:\r\n* Systemic chemotherapy or biologic therapy =< 2 weeks or 5 half lives (t 1/2) of the agent used, whichever is shorter, prior to the start of neratinib \r\n* Radiation therapy outside the central nervous system days prior to neratinib \r\n* Radiation to the central nervous system =< 12 weeks prior to initiation of neratinib
Administration of an investigational drug within 14 days or 5 half-lives, whichever is shorter, preceding the first dose of study treatment(s) in this study.
Receipt of any investigational agent within 14 days or 5 half-lives of starting BP1001
Received previous chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 21 days or 5 half-lives for targeted therapies prior to this study entry.
In the absence of rapidly progressing disease, the interval from prior treatment to time of initiation of IACS-010759 administration will be at least 2 weeks or 5 half-lives (whichever is shorter) for cytotoxic/noncytotoxic agents and biological/immune therapies, including investigational agents; the half-life for the therapy in question will be based on published pharmacokinetic literature (abstracts, manuscripts, investigator brochures, or drug-administration manuals) and will be documented in the protocol eligibility document; the use of chemotherapeutic or anti-leukemic agents is not permitted during the study with the following exceptions: (1) intrathecal therapy for subjects with controlled CNS leukemia at the discretion of the principal investigator (PI) and with the agreement of the sponsor; (2) use of hydroxyurea for subjects with rapidly proliferative disease is allowed before the start of study therapy and for the first 2 cycles on therapy; these medications will be recorded in the case-report form
Participation in any other clinical trial involving another investigational agent for the treatment of AML within 2 weeks prior to day 1 of the study or at least 5 half-lives of the investigational agent, whichever is shorter
Receipt of any conventional or investigational anticancer therapy not otherwise specified above within 28 days of 5 half-lives of the agent prior to the first dose of durvalumab and tremelimumab
Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is shorter) before study drug administration
Patients who receive treatment with systemic immunostimulatory agents (including but not limited to IFNs, IL-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to study registration are not eligible
Anti-cancer therapy, such as chemotherapy, immunotherapy, targeted, and hormonal/endocrine therapy, or investigational agents within five half-lives or four weeks, whichever is shorter, prior to administration of the first dose of study drug (five half-lives or two weeks, whichever is shorter, for orally administered drugs and six weeks for nitrosoureas, mitomycin C, or bevacizumab)
Treatment with an investigational drug within five half-lives of the compound
Use of investigational products or other anti-leukemic therapy within 5 half-lives or within 14 days prior to UCART19 administration whichever has a shorter duration
Three weeks or 5 half-lives (whichever is shorter) from previous systemic anticancer therapy; at least 4 weeks from major surgery and recovered; at least 2 weeks from palliative radiation and recovered; no more than 450 mg/m^2 cumulative dose of doxorubicin or equivalent anthracycline dose is allowed
Patients must be at least 4 weeks or 5 half-lives (whichever is shorter) from the last dose of prior investigational anti-cancer drugs.
Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) =< 14 days prior to the first dose of study drug (=< 7 days or four half-lives, whichever is longer, prior to the first dose of study drug for subjects who have received prior tyrosine kinase inhibitors [TKIs] [e.g., erlotinib, gefitinib and crizotinib] and within 6 weeks for nitrosourea or mitomycin C)
At least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody
At least 4 weeks beyond the last chemotherapy (or ? 5 half-lives for targeted agents, whichever is shorter), radiotherapy, major surgery or experimental treatment and recovered from all acute toxicities (? Grade 1)
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 time that is shorter than the cycle length used for that treatment (e.g., 6 weeks for nitrosourea, mitomycin-C)\r\n* Biological therapy (e.g., antibodies - including bevacizumab) within a period of time that is =< 5 half-lives or =< 4 weeks, whichever is shorter, prior to starting study drug\r\n* Continuous or intermittent small molecule therapeutics within a period of time that is =< 5 half-lives or =< 4 weeks (whichever is shorter) prior to starting study drug\r\n* Any other investigational agents within a period of time that is =< 5 half-lives or less than \tthe cycle length used for that treatment or =< 4 weeks (whichever is shortest) prior to starting study drug\r\n* Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug
Patients who have received an investigational anti-cancer drug within two weeks (or five half-lives, whichever is shorter) of LY251092 administration
A minimum of 5 half-lives of last dose of investigational agent must have elapsed prior to C1D1.
WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 23 weeks after the last dose of investigational product; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; these durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days
Patients may not have received any other investigational agents within 2 weeks or 5 half life’s prior to registration, whichever is shorter
Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL]-2) within 4 weeks or five half-lives of the drug, whichever is shorter
Treatment with an investigational drug within five half-lives of the compound or any of its related material.
Patients who have received prior systemic therapy < 14 days prior to study registration or have not recovered adequately from toxicities to CTCAE v. 4.03 grade 1 or less; prior investigational therapy may not have been given < 5 half-lives of last dose of treatment, or < 14 days, whichever is greater
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
any anti-cancer therapy including blinatumomab, chemotherapy, radiation therapy targeted small molecule agents or investigational agents within 14 days, or 5 half-lives, whichever is shorter
Subject has received anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic or any investigational therapy within a period of 21 days or 5 half-lives (whichever is shorter) prior to study day 1
At least 4 weeks beyond the last chemotherapy (or ? 5 half-lives for targeted agents, whichever is shorter), radiotherapy, major surgery or experimental treatment and recovered from all acute toxicities (? Grade 1)
In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be ? 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. Persistent clinically significant toxicities from prior chemotherapy or radiotherapy must not be greater than Grade 1.
Chemotherapy or immunotherapy < 5 half-lives prior to screening.
At least 3 half-lives must have elapsed after treatment with a monoclonal antibody and enrollment on this study
Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrollment
Has received any prior systemic therapy, excluding corticosteroids, within 7 days (or 5 half-lives) of treatment
The interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents; if the patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must be off hydroxyurea for at least 24 hours before initiation of treatment on this protocol; persistent clinically significant toxicities from prior therapy must not be greater than grade 1
Patients receiving any other standard or investigational treatment for their hematologic malignancy within past 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents
In the absence of rapid progressive disease, the interval from prior systemic anticancer treatment to time of TAK-659 administration should be at least 2 weeks for cytotoxic agents (other than hydroxyurea), or at least 5 half-lives for noncytotoxic agents, and participants have to have recovered from acute toxicities of these therapies. Participants who are on hydroxyurea may be included in the study and may continue on hydroxyurea for the first 28 days while participating in this study.
Systemic anti-cancer treatment (including investigational agents) <=21 days or <= 5*their half-lives before the first dose of study treatment. (For example, if the 5*the half-life is shorter than 21 days, 5*half-life should be used as the washout period. However, a minimum of 10 days should elapse from prior therapy to initiating protocol therapy.)
At least 3 half-lives from time of last dose of anti-tumor directed antibody therapy or 30 days, whichever is shorter
Patients who received the last administration of an anti-cancer therapy including, chemotherapy, immunotherapy/biologic therapy, targeted therapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or within 5 half-lives, whichever is shorter, prior to entering the study
Patients who have received any continuous or intermittent small molecule therapeutics (excluding monoclonal antibodies) =< 5 effective half-lives prior to registration or who have not recovered from side effects of such therapy
Patients who have completed previous systemic therapies 5 drug half-lives or 4-weeks prior to enrollment on study, whichever is shorter; Note: patients with anaplastic thyroid will be waived from this inclusion criteria
The patient is less than 5 half-lives from prior ALK inhibitor or targeted therapy (for adequate wash-out) without recovery from treatment toxicities to < grade 1 or to their pre-treatment levels
The last dose of investigational agents must be at least 2 weeks before leukapheresis procedure unless no response or disease progression is documented on the experimental therapy and at least 3 half-lives must have elapsed prior to leukapheresis
Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of trametinib and during the study
Patients who are receiving any other investigational agents; patients who have taken an investigational drug within 28 days or 5 half-lives (minimum 14 days), whichever is shorter, prior to randomization
Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study drug(s) and during the study
Patients on prior investigational agents must wait at least 5 half-lives before enrollment into the trial, or 4 weeks if the half-life of the investigational agent is not known.
The subject has received any of the following prior anticancer therapy:\r\n* Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT) to the target site\r\n* Radiation therapy within 12 weeks of screening\r\n* Systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (e.g., tamoxifen) within 14 days or 5 half-lives, whichever is shorter, prior first dose of study drug\r\n* Biologic agents (antibodies, immune modulators, vaccines, and cytokines) within 21 days prior to first dose of study drug\r\n* Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug\r\n* Prior treatment with carmustine wafers\r\n* Patients who are currently receiving any other investigational agents and/or who have received an investigational agent in the prior 28 days
At least 3 half-lives should have elapsed since therapy with a monoclonal antibody
Receipt of systemic anti-lymphoma therapy within the following intervals prior to the therapeutic 90Y-ibritumomab tiuxetan dose:\r\n* < 30 days for intravenously-administered cytotoxic chemotherapy and/or monoclonal antibodies\r\n* < 5 half-lives for all other anti-cancer agents (e.g., targeted therapies, corticosteroids, immunomodulatory agents, etc.)
Monoclonal antibody treatment and agents with known prolonged half-lives: at least three half-lives must have elapsed prior to enrollment
Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.
Received non-biologic anticancer medication within 5 half-lives prior to receiving the first dose of study drug (within 6 weeks for mitomycin-C or nitrosoureas), within 28 days for any antibodies or biological therapies
-  Investigational Agents: Investigational agents within 4 weeks (or 5 half-lives) of PV-10 administration.
Phototoxic or Photosensitizing Agents: Concomitant agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of PV-10 administration.
Antibodies: 3 half-lives must have elapsed from infusion of last dose of antibody (including checkpoint inhibitors), and toxicity related to prior antibody therapy must be recovered to Grade ?1.
Prior chemotherapy, targeted therapy or monoclonal antibody therapy within 3 weeks of start of study treatment (Day1), or 5 half-lives, whichever is shorter.
Investigational therapy administered <5 half-lives before the first dose of HTI-1066
Any anticancer therapy administered <5 half-lives before first dose of HTI-1066; any prior immune-oncology products administered within 4 weeks or 5 half-lives before the first dose of HTI-1066 as described above; or surgery or radiotherapy administered within 4 weeks before the first dose of HTI-1066.
Treatment with an investigational drug within five half-lives of the compound
Have had prior systemic chemotherapy treatments or investigational modalities ? 5 half-lives or 4 weeks, whichever is shorter, prior to starting treatment with Andes-1537 or who have not recovered from side effects, grade 2 or greater, of such therapy (except alopecia)
Received prior systemic anticancer treatment (chemotherapy, targeted therapies including kinase inhibitors, antibodies, etc) less than 5 half-lives before the first dose of study drug or radiotherapy within 30 days; toxicity of the anticancer treatment must have recovered to grade 1 or less.
Chemo-, hormone- or immunotherapy, within 4 weeks or within less than four half lives of the date of first administration of study drug and/or persistence of toxicities of prior anti-cancer therapies which are deemed to be clinically relevant
Use of any investigational agents within 28 days or 5 half-lives (whichever is shorter) of study treatment.
Patients who have received any continuous or intermittent small molecule therapeutics (excluding monoclonal antibodies) =< 5 effective half lives prior to starting study drug or who have not recovered from side effects of such therapy
Use of an investigational drug within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug. Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs. Prior BCMA targeted therapy.
Use of anti-cancer treatment drug =< 21 days or 5 half-lives (whichever is shorter) prior to the first dose of AZD1775; for drugs for which 5 half-lives is =< 21 days, a minimum of 10 days between termination of the prior treatment and administration of AZD1775 treatment is required
Any systemic therapy, including monoclonal antibody within 28 days or 5 half-lives (whichever is shorter) of initiating protocol therapy
Have received treatment with systemic immunomodulatory agents within 28 days prior to administration of the first dose of CMB305, or 5 half-lives of the drug, whichever occurs sooner.
Treatment with chemotherapy, immunotherapy, radiotherapy, targeted small molecule\r\ninhibitors, biologic agents, and/or an investigational therapy for 5 half-lives prior to first study dose of venetoclax; treatment with a biologic agent, such as a monoclonal antibody, for 30 days prior to study treatment; treatment with ibrutinib is allowed
Discontinuation of all therapy (including radiotherapy, chemotherapy, tyrosine-kinase inhibitors [TKIs], immunotherapy or investigational therapy) for the treatment of cancer as follows:\r\n* At least 1 week or 5 half-lives (whichever is longer) from the last dose of prior anti-cancer therapy and the initiation of study therapy\r\n* Exceptions or modifications to the above are as follows:\r\n** Medications that are typically part of a maintenance therapy for ALL, such as glucocorticoids or mercaptopurine, may be administered up to 3 days prior to the first dose, except vinca alkaloids which must be discontinued at least 14 days prior to the start of study treatment; TKIs are not permitted to be continued at screening (e.g. Gleevec)\r\n* Intrathecal (IT) chemotherapy may be dosed up to 7 days prior to first dose of pembrolizumab (cytarabine [Ara-C] recommended)\r\n* For biologics (e.g. monoclonal antibodies), washout period of 1 month beyond the recommended dosing interval and at least 4 weeks or 5 half-lives (whichever is longer) since the last dose
Receiving any other investigational agents within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug
Treated with systemic anticancer therapy or an investigational agent within 2 weeks or 5 half-lives, whichever is shorter, prior to start of study drug treatment. Washout will be 2 weeks for antibody therapy and immunotherapy.
Participation in another clinical study with an investigational product during the last 4 weeks or 5 half-lives prior to starting on treatment.
Prior Treatment:\r\n* PARP inhibitor: Most oral PARP inhibitors (the immediate prior therapy) have a half-life for which 5 half-lives is </= 21 days. Thus, a minimum of 10 days between termination of the prior treatment and administration of olaparib and/or AZD1775 treatment is required. In the event a PARP inhibitor has a longer half-life where 5 half-lives is >= 21 days, treatment of olaparib and/or AZD1775 should not begin for 5 half-lives or at least 21 days, whichever is shorter.\r\n* Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration (study enrollment). Continuation of hormone replacement therapy is permitted.\r\n* Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to first dose of study drug (6 weeks for nitrosoureas or mitomycin C).
Treatment with systemic immunostimulatory agents (including but not limited to interferon [IFN] or interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to cycle 1, day 1.
Patients must not have received an investigational agent within 4 weeks or ? 5 half lives, whichever is shorter, prior to starting study treatment
Patients who have received any other investigational product within14 days of treatment are not eligible for this study; a wash out period ? 14 days or 5 half- lives (whichever is greater) is required from investigational treatment, prior to start of study treatment; please Note:\r\n* If patient is registered prior to completion of washout, start date of treatment will need to be confirmed prior to registration; please see assigned QAM with questions\r\n* The ‘5 half-lives’ time period will be determined by investigational pharmacy\r\n* If half life is not known and cannot be predicted, then wash out of ? 14 days is required
At least 4 weeks or 5 half-lives, whichever is shorter, must have elapsed from the use of any anti-cancer therapy prior to randomization
Taking immunomodulatory agents (including steroids and nonsteroidal anti-inflammatory drugs [NSAIDs]). A wash-out period of at least 4 weeks or 5 half-lives, whichever is shorter, is required for patients receiving immunomodulatory agents at the time of enrollment
The subject has received any other type of investigational agent within 28 days or 5 half-lives, whichever is shorter, before the first dose of study treatment
Treatment with systemic immunostimulatory agents (including, but not limited to, interferon-alpha or interleukin-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to registration
Any concurrent chemotherapy, investigational product (IP), biologic, or hormonal therapy for cancer treatment; receipt of any investigational or approved anticancer therapy (chemotherapy, targeted therapy, biologic therapy, monoclonal antibodies, etc.) within 21 days or 5 half lives, whichever is shorter, prior to the first dose of MEDI0457; concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
Any systemic therapy, including monoclonal antibody within 28 days or 5 half-lives (whichever is shorter) of initiating day 1 of protocol therapy
Anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal or any investigational therapy within 14 days or 5 half-lives (whichever is shorter) prior to first dose of study drug; hydroxyurea is permitted up to the day before initiation of study treatment
Treatment with systemic immunostimulatory agents (including but not limited to interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to cycle 1, day 1
Refractory/recurrent patients\r\n* Patients must have recovered from the acute treatment related toxicities (defined as < grade 1) of all prior chemotherapy, immunotherapy, radiotherapy or any other treatment modality prior to entering this study\r\n* Myelosuppressive chemotherapy\r\n** Patients must have received their last dose of known myelosuppressive anticancer therapy at least 21 days prior to enrollment or at least 42 days if nitrosourea\r\n* Biological agent: \r\n** Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the biologic agent >= 7 days prior to study enrollment\r\n** For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur\r\n* Monoclonal antibody treatment and agents with known prolonged half-lives: at least three half-lives must have elapsed prior to enrollment; \r\n** Note: a list of the half-lives of commonly used monoclonal antibodies is available on the Pediatric Brain Tumor Consortium (PBTC) webpage under Generic Forms and Templates\r\n* Radiation \r\n** Patients must have had their last fraction of: \r\n*** Craniospinal irradiation (> 24 Gy) or total body irradiation or radiation to >= 50% of pelvis > 3 months prior to enrollment\r\n*** Focal irradiation > 6 weeks prior to enrollment\r\n*** Local palliative irradiation (small port) >= 4 weeks\r\n* Autologous stem cell transplant \r\n** Patient must be >= 6 months since autologous bone marrow/stem cell transplant prior to enrollment and have CD4 counts above 200/mm^3
Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to initiation of study treatment
From the projected start of scheduled study treatment, the following time periods must have elapsed:\r\n* 4 weeks or 5 half-lives (whichever is shorter) from any investigational agent;\r\n* 4 weeks from cytotoxic therapy (except 23 days for temozolomide; 6 weeks from nitrosoureas);\r\n* 6 weeks from antibodies;\r\n* 4 weeks or 5 half-lives (whichever is shorter) from other anti-tumor therapies.\r\n* 2 days from Novo-Tumor Treating Fields (TTF)
Patients treated with systemic immunostimulatory agents (such as interferons, IL 12) within 6 weeks of the start of the treatment or 5 half-lives of the drug, whichever is shorter
WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug (half-life up to 25 days) plus 30 days (duration of ovulatory cycle) for a total of 5 months post-treatment completion
Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug (s) plus 5 half-lives of the study drug (half-life up to 25 days) plus 90 days (duration of sperm turnover) for a total of 7 months post-treatment completion
Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of talimogene laherparepvec (T-VEC) and during the study
Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study treatment and during the study; patients that have used other BRAF or mitogen-activated protein kinase kinase (MEK) inhibitor are excluded
The subject has received small-molecular kinase inhibitors or any other type of investigational agent within 4 weeks before the first dose of study treatment or 5 half-lives of the compound or active metabolite, whichever is shorter
Patients must have sufficiently recovered (=< grade 1) from any toxicity of prior therapy; the required waiting period between the last dose of the most recent chemotherapy agent and the first dose of eribulin will be determined based on the half-life of the chemotherapy agent; the minimum time between stopping prior therapy and administering the first dose of eribulin should be 3.3 half-lives with the following exceptions: an interval of at least 6 weeks must elapse since treatment with a nitrosourea and at least 4 weeks since the last dose of bevacizumab
Treatment with systemic immunostimulatory agents (including but not limited to IFN-alpha, IL-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to cycle 1, day 1
Subjects who have received an investigational agent within 30 days OR within 5 half-lives of the investigational agent (whichever is shorter) prior to the possible enrollment date on this study
Patients must have recovered from clinically significant toxicity of prior therapy to grade =< 1 or pre-treatment baseline; the following intervals from previous treatments are required prior to day 1 of study therapy:\r\n* 12 weeks from the completion of radiation for recurrent GBM unless there is surgical diagnosis of recurrence or a new lesion that was not previously radiated\r\n* 6 weeks from a nitrosourea chemotherapy\r\n* 3 weeks from a non-nitrosourea chemotherapy\r\n* 4 weeks from an investigational agent (not Food and Drug Administration [FDA] approved) (or 5 half lives, whichever is shorter)\r\n* 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g., erlotinib, hydroxychloroquine, etc.) (or 5 half lives, whichever is shorter)
Patients who have received radiation therapy to more than half of the pelvis or more than half of the spine within =< 2 weeks prior to starting study treatment; or who have not yet recovered from side effects of such therapies
Use of other anti-cancer therapies within five half-lives from the previous dose of the prior anti-cancer therapy preceding enrollment and during the study
Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study treatment and during the study
Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study treatment and during the study
Previous treatment with other HER2 targeted agents allowed; (previous treatment with HER2 inhibitors and investigational drugs to be discontinued prior to starting study treatment [at least 21 days for trastuzumab and other antibodies; at least 14 days for lapatinib; at least 5 half-lives for other agents])
Patients who have received any continuous or intermittent small molecule therapeutics (excluding monoclonal antibodies) =< 5 effective half lives prior to starting study drug or who have not recovered from side effects of such therapy
Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to the planned start of study treatment.
Treatment with any other investigational agent, device, or procedure, within 21 days (or 5 half-lives, whichever is greater) of enrollment. Subjects participating in a GVHD prophylaxis study or conditioning regimen should be discussed with the sponsor's medical monitor before enrollment.
Systemic anti cancer therapy completed within a minimum of 5 half lives of study entry.
Treatment with another investigational drug (with the exception of anticancer immune therapy) or device, or approved therapy for investigational use, within 5 times the half-life of the drug or within 3 weeks prior to study day 1 if the half life is not known.
Treatment with systemic immunostimulatory agents (including but not limited to interleukin-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to first dose.
Treatment with systemic immunostimulatory agents within 6 weeks or five half-lives of the drug, whichever is shorter, prior to first dosing.
Patient must not be taking drugs known to prolong the QTc interval; such drugs should be discontinued at least 5 half-lives prior to randomization
Has received prior treatment with a monoclonal antibody within 5 half-lives of Study Day 1
Use of any other experimental medication(s) within 14 days or 5 half-lives but in no case < 14 days prior to the start of the study treatment on Cycle 1, Day 1.
Major surgery, chemotherapy, systemic therapy (excluding hydroxyurea, steroids, and any targeted small molecules or biologics), or radiotherapy, or biotherapy targeted therapies within 14 days or 5 half-lives (whichever is shorter) prior to Cycle 1, Day 1 treatment, except if approved by the Sponsor.
Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, biologic, targeted therapy, or any investigational therapy within either 14 days or 5 half-lives (whichever is shorter), prior to study drug administration
Treatment with investigational drug </= 3 weeks or 5 half-lives before study treatment
Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of trametinib or standard of care agent
Received prior treatment (for any reason)with a monoclonal antibody within 5 half-lives of initiating study treatment
Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug (whichever is shorter) prior to randomization
Receiving systemic immunostimulatory agents within 6 weeks or 5 half-lives, whichever is shorter, prior to first dose of study treatment (except ant PD-1/PD-L1 treatment if recruited into Group 4a or 4b).
Has received prior treatment with a monoclonal antibody within 5 half-lives of Study Day 1
Treatment with hormonal therapy (except hormone replacement therapy or oral contraceptives) or biologic therapy within 4 weeks or 5 half-lives, whichever is shorter, prior to initiation of study drug. This requirement may be waived at the investigator's request if the participant has recovered from therapeutic toxicity to the degree specified in the protocol, with approval of the Medical Monitor
Systemic chemotherapy, biological therapy, immunotherapy or investigational agents within 5 half-life of the drug or within four weeks prior to the start of afatinib treatment (if the half-life of the drug is unknown).
Treatment with systemic immunostimulatory agents (including but not limited to interferon, interleukin-2) within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1
Monoclonal antibody; at least three half-lives since the last dose
Use of any other experimental medication(s) within 14 days or 5 half-lives but in no case less than 14 days prior to start of study treatment on Cycle 1, Day 1, except if approved by Sponsor.
Major surgery, chemotherapy, systemic therapy (excluding steroids hydroxyurea steroids, and any targeted small molecules or biologics), or radiotherapy, within 14 days or 5 half-lives (whichever is shorter) prior to Cycle 1, Day 1 treatment, except if approved by the Sponsor.
Prior systemic cancer-directed treatments or investigational modalities ? 5 half lives or 4 weeks, whichever is shorter, prior to starting study drug or who have not recovered from side effects of such therapy.
Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.
Anti-tumor therapy (chemotherapy, chemoradiation, radiation, molecular targeted therapy) within 21 days or 5 half-lives whichever is longer, of study drug dosing (6 weeks for nitrosoureas, mitomycin C, or molecular agents with t1/2 > 10 days); 5 half-lives of any investigational drug; concurrent use of goserelin for pre-/peri-menopausal breast cancer and exemestane or fulvestrant per the protocol are permitted
Use of a study drug ?21 days or 5 half-lives, whichever is shorter.
Prior systemic cancer-directed treatments or investigational modalities =< 5 half-lives or 4 weeks, whichever is shorter, prior to starting study drug or who have not recovered from side effects of such therapy (except alopecia)
Administration of an investigational drug within 14 days or 5 half-lives, whichever is shorter with a minimum of 14 days preceding the first dose of study treatment(s) in this study.
Any anticancer therapy including; small molecules, immunotherapy, chemotherapy monoclonal antibodies or any other experimental drug within four weeks or five half lives, whichever is longest, before first infusion.
Use of an investigational drug within 14 days or within 5 half-lives of the investigational drug, whichever is shorter
Treatment with systemic immunostimulatory agents (including but not limited to interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to cycle 1, day 1
Any concurrent anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational agents (with the exception of hydroxyurea or leukapheresis for control of hyperleukocytosis) within 14 days or five half-lives of drugs, whichever is shorter, prior to Cycle 1 Day 1
Prior systemic cancer-directed treatments or investigational modalities ? 5 half lives or 4 weeks whichever is shorter.
Patients currently receiving anticancer therapies (including chemotherapy, radiation therapy, hormonal, or antibody-based therapy); prior treatment should have a washout period of 28 days or 4 1/2 half-lives (7 days), whichever is shorter
At least 28 days or 5 half-lives (whichever is shorter) since prior investigational anti-cancer drugs. A minimum of 21 days between termination of the investigational drug and administration of VAL-083 is required.
Patients may not be receiving any other investigational agents within 5 half-lives of the drug (if known); if the half-life is not known, investigational agents should not be taken within two weeks
Treatment with any investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of study medication
An interval of ?3 weeks since chemotherapy (? 6 weeks for nitrosoureas or mitomycin C), immunotherapy, hormone therapy or any other anticancer therapy or surgical intervention resection, or ?3 half-lives for monoclonal antibodies, or ? 5 half-lives for other non-cytotoxic agents (whichever is longer)
Treatment with other investigational agents =< 30 days or 5 half-lives of registration
Receipt of any investigational anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment.
The individual methods of contraception and duration should be determined in consultation with the investigator; women of childbearing potential (WOCBP) must follow instructions for birth control when the half-life of the investigational drug is greater than 24 hours, contraception should be continued for a period of 30 days plus the time required for the investigational drug to undergo five half-lives; the half-life of nivolumab and ipilimumab is up to 25 days and 18 days, respectively; WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug; WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of investigational product
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year the investigator shall review contraception methods and the time period that contraception must be followed; men who are sexually active with WOCBP must follow instructions for birth control when the half-life of the investigational drug is greater than 24 hours, contraception should be continued for a period of 90 days plus the time required for the investigational drug to undergo five half-lives; the half-life of nivolumab and ipilimumab is up to 25 days and 18 days, respectively; therefore, men who are sexually active with WOCBP must continue contraception for 31 weeks (90 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug
Washout period prior to day 1 cycle 1:\r\n* >= 3 weeks since last chemotherapy or therapeutic radiation therapy\r\n* >= 4 weeks or 3 half-lives since prior antibody-based therapy, whichever is shorter\r\n* >= 2 weeks since any oral anti-neoplastic or oral investigational agent\r\n* Resolution of treatment-related toxicity to =< grade 1; alopecia and cutaneous toxicity are allowed =< grade 2\r\n* >= 1 week since palliative radiotherapy (RT)
Monoclonal antibody treatment and agents with known prolonged half-lives: at least three half-lives must have elapsed prior to enrollment
Receipt of any type of small molecular kinase inhibitor (including investigational kinase inhibitors) within 2 weeks or 5 half-lives (whichever is shorter) of enrollment or receipt of any anti-cancer therapy (including investigational therapy, monoclonal antibodies, cytokine therapy) within 3 weeks of enrollment
Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) either preceding the first dose of ganetespib or during the study period
Prior systemic cancer-directed treatments or investigational modalities =< 5 half-lives or 4 weeks, whichever is shorter, prior to starting study treatment
From the projected start of scheduled study treatment, the following time periods must have elapsed: 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 6 weeks from antibodies, or 4 weeks (or 5 half-lives, whichever is shorter) from other anti-tumor therapies
Patient underwent major surgery within 4 weeks before the first dose of PBI 05204 or received cancer-directed therapy (chemotherapy, radiotherapy, hormonal therapy, biologic or immunotherapy, etc.) or an investigational drug or device within 4 weeks (6 weeks for mitomycin C, nitrosoureas, and liposomal doxorubicin) or 5 half-lives of that agent (whichever is shorter) before the first dose of PBI 05204. (For agents in which the total of 5 half-lives is <10 days, there must be a minimum of 10 days between termination of the investigational drug and administration of PBI 05204). Note that prior liver-directed therapies will be permitted (i.e., chemoembolization, radioembolization), as long as target lesions in the liver have demonstrated growth after the liver-directed treatment. Any drug-related toxicity, with the exception of alopecia, should have recovered to ? Grade 1.
Subjects who are using moderate or strong CYP450 3A4 modulators (with the exception of antifungal agents listed in Appendix 2) within 5 half-lives before the first dose of study drug.
Receipt of any investigational anticancer therapy within 28 days or 5 half-lives;
Patient has received chemotherapy or targeted anticancer therapy, monoclonal antibodies =< 4 weeks or 5 half-lives, whichever is shorter, or 6 weeks for nitrosourea or mitomycin-C prior to starting the study drug, or the patient has not recovered side the side effects of such therapy
Treatment with an investigational drug within five half-lives of the compound or any of its related material.
Patients must be >= 4 weeks beyond treatment with any chemotherapy or other investigational therapy to include hormonal, biological, or targeted agents; or at least 5 half-lives from hormonal, biological, or targeted agents, whichever is shorter at the time of treatment initiation
Patients who have received any continuous or intermittent small molecule therapeutics (excluding monoclonal antibodies) =< 5 effective half-lives prior to starting study drug or who have not recovered from side effects of such therapy
Prior randomization or treatment in a previous MEDI4736 and/or tremelimumab clinical study regardless of treatment arm assignment or receipt of any investigational anticancer therapy within 28 days or 5 half-lives
Use of any approved tyrosine kinase inhibitors or investigational agents within 2 weeks or 6 half-lives of the agent, whichever is shorter, prior to receiving study drugs
Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment
At least 3 weeks from previous cytotoxic chemotherapy or radiation therapy and at least 5 half-lives or 6 weeks, which ever is shorter, after targeted or biologic therapy
Use of an investigational drug within 28 days or 5 half-lives prior to first dose.
Patient was treated with any experimental agent within 14 days or five half-lives of study treatment, whichever is greater.
Subjects must have completed at least 3 half-life periods from the last dose of monoclonal antibody prior to registration \r\n* Note: a list of half-lives of commonly used monoclonal antibodies is available on the Pediatric Brain Tumor Consortium (PBTC) website under Generic Forms and Templates
The patient has received any biological therapy ? 7 days prior to the start of Investigational Product, or monoclonal antibody ? 3 half-lives or 28 days, whichever is shorter, prior to the first dose of Investigational Product.
Participants may not be receiving any other investigational agents nor have participated in an investigational trial within the past 4 weeks (or five half-lives whichever is shorter; with a minimum of 14 days from the last dose)
At least 3 antibody half?lives must have elapsed since the last dose of monoclonal antibody (e.g., 66 days for rituximab and 69 days for epratuzumab) before subjects may initiate study treatment.
For patients currently receiving investigational agents, a washout of at least 2 weeks or 5 half-lives of experimental agent are required prior to the start of radiation therapy (RT)
Treatment with systemic immunostimulatory agents (including but not limited to interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to cycle 1, day 1
Experimental agents, including off-label use of approved drugs, within 4 weeks prior to leukapheresis unless progression is documented on the experimental therapy and at least 3 half-lives have elapsed prior to leukapheresis
PART B: No previous treatment with a standard or investigational anti-cancer agent within predicted 5 half-lives of the agent; or 28 days whichever is the shorter; if the plasma half-life is not known or the previous therapy was a monoclonal antibody then a 28 day washout period will be considered as the default requirement
Participants may not have had other anti-neoplastic therapies within the following timelines:\r\n* Radiation within 2 weeks\r\n* Cytotoxic chemotherapy or monoclonal antibodies within 2 weeks, if all treatment-related toxicities have resolved to =< grade 1 prior to starting study treatment\r\n* EGFR tyrosine kinase inhibitor within 2 weeks\r\n* Any other small molecule inhibitor within 2 weeks or 5 half-lives of the compound, whichever is shorter\r\n* Experimental treatment of any type within 30 days
Patient has had any treatment specific for tumor control within 3 weeks of dosing with investigational drugs and cytotoxic agents, or within 2 weeks of cytotoxic agent given weekly, or within 6 weeks of nitrosoureas or mitomycin C, or within 5 half-lives of biological targeted agents with half-lives and pharmacodynamic effects lasting less than 5 days
Receiving any other investigational agent(s) within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug; a minimum of 10 days between termination of the investigational drug and administration of study drug is required
Any cancer-directed therapy (chemotherapy, radiotherapy, hormonal therapy, biologic or immunotherapy, etc.) within 28 days or 5 half-lives, whichever is shorter
Any use of an investigational drug within 28 days or 5 half-lives (whichever is shorter) prior to the first dose of BVD-523.
The interval from prior treatment to time of study drug administration is < 2 weeks for cytotoxic agents or < 5 half-lives for noncytotoxic agents. Exceptions: Use of hydroxyurea is allowed before the start of study and may be administered up to day 5 of the first cycle.
Investigational or anti-cancer therapy within 5 half-lives prior to the first dose of study drug
Patient must not have received chemotherapy or radiotherapy =< 4 weeks or 5 half-lives prior to study entry
Concurrent investigational agents for non-malignant disease or prior investigational agents for non-malignant disease within 4 weeks or 5 half-lives (whichever is shorter) prior to day 1
Monoclonal antibodies: interval >= 3 half-lives before study enrollment; such cases will need to be discussed with the principal investigator
Patients must be at least 3 weeks past receiving cytotoxic therapy and at least 5 half-lives after their previous treatment or 3 weeks, whichever is shorter, after biologic therapy; patients may receive palliative radiotherapy immediately or during treatment provided that not all target lesions are radiated
Patient has had any treatment specific for tumor control within 3 weeks of dosing with investigational drugs and cytotoxic agents, or within 2 weeks of cytotoxic agent given weekly, or within 6 weeks of nitrosoureas or mitomycin C, or within 5 half-lives of biological targeted agents with half-lives and pharmacodynamic effects lasting less than 5 days (that includes, but is not limited to, erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents)
Patient must be at least 4 weeks or five half-lives (whichever is shorter) from last standard or experimental therapy, except:\r\n* Patients who have received prior pazopanib are eligible but must not have received it in the last two weeks
Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug (whichever is shorter) prior to the first dose of study drug and for the duration of the study
Prior cancer-directed modalities or investigational drugs within 4 wks or 5 half lives, whichever is shorter
Patients may not be receiving any other investigational agents within the past 28 days; NOTE: if agent’s half-life x 5 is < 28 days, patient may have taken it within the last 28 days, provided at least 5 half-lives have passed since having last taken it
Use of any investigational anti-cancer drug within 14 days or 5-half-lives (minimum 14 days), prior to start of study medication (Note: Dabrafenib monotherapy within 14 days prior to starting combination therapy is allowed for crossover subjects in Cohort A);
Patients must have been off previous chemotherapy or radiotherapy for the three weeks prior to entering this study; six weeks will be required if the patient has received therapy which is known to have delayed toxicity (mitomycin or a nitrosourea); five half-lives will be required for biologic/targeted therapies with short (< 24 hour) half-lives and pharmacodynamic effects; patients may have received palliative radiation immediately before (or during) treatment provided radiation does not target the only measurable or evaluable disease
Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.
Prior treatment anti-cancer therapy or use of any investigational agent within the past 28 days or 5 half-lives, whichever is shorter;
Patients must be off prior cytotoxic chemotherapy for at least three weeks; for biologic or targeted therapy, there should be five half lives or three weeks, whichever is shorter, between their last treatment and the first dose on this trial
Receipt of any chemotherapy or small molecule targeted therapy (such as imatinib or other tyrosine kinase inhibitors, and including any experimental therapies) or radiation therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of MEDI-551
Subject has received investigational therapy within 28 days or 5 half-lives prior to the first dose of study drug.
Biological therapy within 5 half-lives prior to C1D1
Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to the planned state of study treatment.
Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of trametinib/GSK2141795 and during the study
The interval from prior treatment to time of initiation of FLX925 administration will be ? 2 weeks for cytotoxic agents and ? 5 half-lives for investigational/non-cytotoxic agents. For patients with rapidly proliferative disease, use of hydroxyurea is allowed if started prior to initiation of study therapy;
Administration of an investigational drug within 28 days or 5 half-lives, whichever is shorter preceding the first dose of study treatment(s) in this study.
Cancer-directed therapy (chemotherapy, radiotherapy, hormonal therapy with the exception of LHRH agonists for prostate cancer, biologic or immunotherapy, etc.) within 21 days of the first dose of study drug or 5 half-lives, whichever is shorter. Palliative radiotherapy is allowed prior to initiating treatment if associated toxicity resolved to ? Grade 1.
14. Use of an investigational drug within 28 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug. A minimum of 14 days between termination of the investigational drug and administration of the study treatment is required. In addition, any drug-related toxicity except alopecia should have recovered to grade 1 or less.
Treatment with systemic immunostimulatory agents (including but not limited to IFN , IL-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to Cycle 1, Day 1
Have an interval of ?3 weeks (or ?2 weeks for NMC participants) since chemotherapy (?6 weeks for nitrosoureas or mitomycin C), immunotherapy, hormone therapy or any other anticancer therapy or surgical intervention resection, or ?3 half-lives for monoclonal antibodies, or ?5 half-lives for other non-cytotoxic agents (whichever is longer)
Patients who are receiving any other investigational agents within 14 days or 5 effective half-lives (whichever is shorter) prior to first (1st) dose of ibrutinib
Treatment with other anticancer drugs within 28 days or 5 half-lives of anticancer therapy (whichever is shorter) is prohibited from 30 days prior to the first dose of SNX-5422 and throughout the study.
At least 28 days or 5 half-lives, whichever is shorter, from the completion of anti-cancer treatment (including, but not limited to, immunotherapy, chemotherapy, targeted therapy and biologic therapy) to the start of study treatment, excluding ibrutinib where the window may be less and at minimum 3 days (modified by amendment 1)
Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to first dose of study treatment.
Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to the planned start of study treatment.
Cancer-directed therapy (chemotherapy, radiotherapy) within 21 days of the first dose of study drug or 5 half-lives, whichever is shorter.
Anticancer chemotherapy or immunotherapy during the study or within less than 3 half-lives for anticancer chemotherapy or 6 weeks for antibody therapies (2 weeks for leukemia patients) prior to start of study drug.
Anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal or any investigational therapy within 14 days or 5 half-lives (whichever is shorter) prior to first dose of study drug.
Patients who have received any continuous or intermittent small molecule therapeutics (excluding monoclonal antibodies) =< 5 effective half lives prior to starting study drug or who have not recovered from side effects of such therapy
Patients who have received any continuous or intermittent small molecule therapeutics (excluding monoclonal antibodies) =< 5 effective half-lives prior to starting study drug or who have not recovered from side effects of such therapy
Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study therapy and during the study
Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 28 days or 5 drug half-lives (if drug half-life in patients is known), whichever is shorter (or within 6 weeks for mitomycin C) before start of the study treatment
Use of a study drug ?21 days or 5 half-lives (whichever is shorter) prior to the first dose of AZD1775
Previous investigational drug or any anticancer therapy in the 30 days (or 5 half-lives for non-cytotoxics, whichever is shorter) prior to the start of trial treatment
Received an investigational anti-cancer drug within 6weeks, or within 5 half-lives (whichever is shorter) of the first dose of study drug(s). A minimum of 14 days must have passed between the last dose of prior investigational agent and the first dose of study drug.
Investigational/biologic agent: \r\n* Biologic or investigational agent (anti-neoplastic): patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent >= 7 days prior to study registration \r\n** For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur\r\n* Monoclonal antibody treatment and agents with known prolonged half-lives: at least three half-lives must have elapsed prior to registration; Note: a list of the half-lives of commonly used monoclonal antibodies is available on the Pediatric Brain Tumor Consortium (PBTC) webpage under Generic Forms and Templates
Treatment with systemic immunostimulatory agents within 6 weeks or five half-lives of the drug, whichever is shorter, prior to the first dose of study treatment
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Monoclonal antibody treatment and agents with known prolonged half-lives: at least three half-lives must have elapsed prior to enrollment\r\n* Note: A list of the half-lives of commonly used monoclonal antibodies is available on the Pediatric Brain Tumor Consortium (PBTC) webpage under Generic Forms and Templates
No treatment with investigational agents within 4 weeks prior to study drug administration, except patients receiving targeted therapies such as kinase inhibitors with half-lives < 48 hours may be treated if > 14 days have elapsed after the last dose and related toxicities have recovered to =< grade 1
Received an investigational agent within 4 weeks prior to enrollment, except patients receiving targeted therapies such as kinase inhibitors with half-lives < 48 hours may be treated if > 14 days have elapsed after the last dose and related toxicities have recovered to =< grade 1
Treatment with any anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy, or herbal therapy within 3 weeks or 5 half-lives (for systemic agents), whichever is shorter
Treatment with an investigational drug within the past 30 days or 5 half-lives of that drug, whichever is shorter.
< 5 half-lives for all other anticancer medications, or sponsor approval
Subject has received small-molecular kinase inhibitors or any other type of investigational agent within 4 weeks before the first dose of study treatment or 5 half-lives of the compound or active metabolite, whichever is shorter
Any cancer-directed therapy within 28 days or 5 half-lives, whichever is shorter
Any concurrent or prior use of an investigational drug (including MEK inhibitors) within previous 28 days or 5 half-lives, whichever is shorter
chemotherapy including molecular-targeting therapy within 21 days (for molecular-targeted agents that are not associated with myelosuppression or immunosuppression, the minimum interval is 5 half-lives if that is less than 21 days)
chemotherapy including molecular-targeting therapy within 21 days prior to planned first dose of study drug (for molecular-targeted agents that are notis 5 half-lives if that is less than 21 days),
Washout from any prior biologic or targeted therapy at least 4 weeks or five times the T1/2 (whichever is shorter) prior to C1D1
Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug plus 30 days (duration of ovulatory cycle). The half-lives of nivolumab and ipilimumab is up to 25 days and 18 days, respectively. Given the blinded nature of this study, WOCBP should therefore use an adequate method to avoid pregnancy for a total of 23 weeks posttreatment completion.
Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half lives of the study drug(s) plus 90 days (duration of sperm turnover). The half-lives of nivolumab and ipilimumab are up to 25 days and 18 days, respectively. Given the blinded nature of this study, men should therefore use an adequate method of contraception for a total of 31 weeks posttreatment completion.
Treatment with any anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy, or herbal therapy within 3 weeks or 5 half-lives (for systemic agents) whichever is shorter
Have received prior systemic anti-cancer therapy or investigational therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first administration of study drug
Prior anti-leukemia therapy within 14 days of enrollment for classical cytotoxic agents, and within 5x the half-life for other investigational agents
Prior systemic cancer-directed treatments or investigational modalities =< 5 half lives or 4 weeks, whichever is shorter, prior to starting study drug or who have not recovered from grade 2 or higher side effects of such therapy (except alopecia); an exception to this would be in patients receiving trastuzumab or pertuzumab immediately prior to trial enrollment, for whom the initial doses of trastuzumab and/or pertuzumab on study can be given within a time frame consistent with clinical guidelines and investigator discretion
Any anticancer therapy including; small molecules, immunotherapy, chemotherapy monoclonal antibodies or any other experimental drug within four weeks or five half lives, whichever is longest, before first infusion.
Another investigational therapy within 28 days or 5 half lives of randomization/enrollment, whichever is shorter.
Cytotoxic therapies or targeted agents that are small molecule inhibitors for 5 half-lives or at least 28 days.
Chemotherapy or other investigational therapy within five half-lives of a biologic agent with a minimum of 28 days prior to the start of Cycle 1
Systemic antineoplastic therapy (including unconjugated therapeutic antibodies and toxin immunoconjugates) or any experimental therapy within 14 days or 5 half-lives, whichever is shorter, before the first dose of either study drug
Treatment with any anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy, or herbal therapy within 3 weeks or 5 half-lives (for systemic agents), whichever is shorter
Taken an investigational drug within 28 days or 5 half-lives (minimum 14 days), whichever is shorter, prior to Study Day 1 (Parts 1 and 2) or randomization (Part 3).
within 6 weeks or 7 half lives prior to the first dose of KTN3379 in the case of anticancer therapy involving MAbs, or
Subject's interval from prior treatment to time of study drug administration is at least 2 weeks for cytotoxic agents (except hydroxyurea given for controlling blast cells), or at least 5 half-lives for prior experimental agents or noncytotoxic agents.
Have received investigational agents or systemic anticancer agents (other than neurotoxic compounds) within 14 days of day 1 of treatment, or 28 days for those agents with unknown elimination half-lives, or known elimination half-lives greater than 50 hours; or 6 weeks for mitomycin C or for nitrosourea agents
Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of trametinib alone or with GSK2141795 and during the study
Treatment with other anticancer drugs within 28 days or 5 half-lives of anticancer therapy (whichever is shorter), and treatment with any other investigational agent is prohibited from 30 days prior to the first dose of SNX-5422 and throughout the study.
The subject must not have received anti-tumor radiotherapy, biologic therapy, chemotherapy, or immunotherapy within 28 days or 5 half lives (whichever is shorter) of the start of Day 1. The subject must not have received hormonal therapy for anti-tumor purposes within 1 week prior to the start of Cycle 1 Day 1.
Subject who has received strong inhibitors or inducers of CYP3A, 1A1, 2D6, or 2C19 within 3 days or five half-lives (whichever is shorter) prior to the first dose of veliparib (applicable to Part 1 only).
Surgery or radiation therapy within 2 weeks; cytotoxic anti-cancer therapy within 3 weeks; non-cytotoxic anti-cancer therapy within 2 weeks, or 5 half-lives (whichever is shorter) of study day 1
Patients may not have had prior chemotherapy, radiotherapy, hormonal therapy, or biologic therapy in the 4 weeks prior to study entry with the exception of mitomycin C or nitrosoureas, for which patients must be 6 weeks from prior treatment. For patients who have been treated with targeted therapy, 5 half-lives of that therapy (or 28 days, whichever is shorter) must have passed prior to enrollment in the study.
Participation in an investigational therapeutic study within three weeks or within five drug half-lives (t1/2) prior to first dose, whichever time is greater (unless enrolling after progression on CMAP compassionate use carfilzomib protocol)
The interval from prior treatment to time of study drug administration should be at least 5 half-lives for cytotoxic and noncytotoxic agents.
Any continuous or intermittent small molecule therapeutics (excluding monoclonal antibodies) =< 5 effective half-lives prior to starting study drug or patients who have not recovered from side effects of such therapy
Any anti-cancer drug therapy within 2 weeks (8 weeks for mitomycin C or nitrosoureas) or 5 half-lives of the drug prior to study treatment, whichever is shorter, prior to study treatment.
Monoclonal antibodies: Last dose of any monoclonal antibodies must have received at least 7 days or 3 half-lives, whichever is longer, prior to the start date for protocol therapy. Please refer to table posted at www.nant.org for definition of half-lives for specific monoclonal antibodies.
Prior use of any MAb, radioimmunoconjugate, or antibody-drug conjugate (ADC) within 4 weeks or 5 half-lives before Cycle 1 Day 1
Use of targeted therapy within two half-lives of registration
Patients who have had anticancer therapy, including kinase inhibitors or any investigational agent within 4 weeks or 5 half-lives (whichever is shorter) (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered to baseline from adverse events (except alopecia and other non-clinically significant adverse events [AEs]); patients who have received prior cabozantinib or inhibitors of c-MET or HGF are ineligible
Ongoing or recent use of a checkpoint inhibitor (eg, nivolumab, pembrolizumab, ipilimumab) within three drug half-lives from the most recent dose to Cycle 1 Day 1
Prior treatment with cytokines is allowed provided that at least 6 weeks or 5 half-lives of the drug, whichever is shorter, have elapsed between the last dose and the proposed Cycle 1, Day 1
Participants previously treated with murine double minute 2 (MDM2) antagonist therapies or participants receiving interferon-alpha, anagrelide, or ruxolitinib within 28 days or 5 half-lives, or hydroxyurea within 1 day, or participants receiving any other cytoreductive or investigational agents within 28 days or 5 half-lives of initial dose. Aspirin is permitted per treatment guidelines for PV unless medically contraindicated
Anticancer therapy including blinatumomab or chemotherapy, radiation therapy, targeted small molecule agents, investigational agents within 14 days or 5 half-lives, whichever is shorter
Prior to the first dose of study treatment, patients who have received systemic antineoplastic therapy or any investigational therapy within 4 weeks or within 5 half- lives of the therapy prior to starting study treatment, whichever is shorter, or for cyclical therapy, within one cycle length (e.g. 6 weeks for nitrosourea, mitomycin-C).
Prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to screening or 5 half-lives of the therapy, whichever is shorter
Patients must be at least 3 weeks after cytotoxic therapy and at least 5 half-lives after their previous treatment or 3 weeks, whichever shorter, after biologic therapy; patients may receive palliative radiotherapy immediately before or during treatment provided that not all target lesions are radiated
RCC patients only: Having received chemotherapy prior to study entry within 5 half-lives of the agent (as described in the package insert), or 4 weeks prior to registration (whichever is shorter) with resolution of side effects from therapy to =< grade 1
At least 21 days or 5 half-lives (whichever is shorter) since prior investigational anti-cancer drugs. A minimum of 10 days between termination of the investigational drug and administration of DAG is required
?4 half-lives for non-cytotoxic therapy prior to C1D1. Patients must have a wash-out period from their last chemotherapy of either ?2 weeks OR at least 4 half-lives prior to C1D1. For patients whose most recent anti-tumor treatment regimen consisted of a multi-agent cocktail, the patient must have a wash-out period of at least 4 half-lives of the agent with the longest half-life.
Any treatment specific for tumor control within 3 weeks of study drugs; or within 2 weeks if cytotoxic agents were given weekly (within 6 weeks for nitrosoureas or mitomycin C), or within 5 half-lives for targeted agents with half-lives and pharmacodynamic effects lasting less than 5 days (that includes but is not limited to erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents); palliative radiation immediately before or during the study is acceptable provided there is evaluable disease that has not been radiated
Patients who have received any continuous or intermittent small molecule therapeutics (excluding monoclonal antibodies) =< 5 effective half lives prior to starting study drug or who have not recovered from side effects of such therapy (except alopecia)
Patients treated with chemotherapy or biologic therapy or other investigational agent < 2 weeks prior to starting study drug for compounds with a half-life ? 3 days, and < 4 weeks prior to starting study drug for compounds with a prolonged half-life were excluded.
Prior therapy with sorafenib or other VEGF- tyrosine kinase inhibitors within 28 days or 5 half lives (whichever is shorter); patients are allowed to have been on prior bevacizumab therapy as long as it was stopped at least 6-8 weeks prior to enrolling on this trial; prior erlotinib is also allowed
Interval from prior treatment to time of study drug at least 5 half-lives for cytotoxic/ noncytotoxic agents.
Interval from prior treatment to time of study drug at least 5 half-lives or 3 wks, which ever is shorter, for noncytotoxic agents
Interval from prior treatment to time of study drug at least 5 half-lives or 3 wks, which ever is shorter, for noncytotoxic agents.
Cancer therapy (chemotherapy with delayed toxicity, radiation therapy, immunotherapy, biologic therapy, or major surgery) within the last 3 weeks; chemotherapy regimens without delayed toxicity within the last 2 weeks; or use of any investigational anti-cancer or other drug within 28 days or 5 half-lives, whichever is longer, preceding the first dose of GSK2118436.
Prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, radiotherapy, or hormonal therapy) within 4 weeks or 5 half-lives (whichever is shorter) of the first dose of study treatment
Requires any concomitant antineoplastic therapy. Prior chemotherapy should not be administered within 5 half-lives or 28 days whichever is shorter. Subjects on a current stable dose of hormonal treatments may continue on a stable dose during the study (i.e. arimidex, amarosin, herceptin).
Patients must have been off previous chemotherapy or radiotherapy for the three weeks prior to entering this study; six weeks will be required if the patient has received therapy which is known to have delayed toxicity (mitomycin or a nitrosourea); five half-lives will be required for biologic/targeted therapies with short (< 24 hour) half-lives and pharmacodynamic effects; patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available
Biologic (anti-neoplastic) agent: At least 7 days since the completion of therapy with a biologic agent; at least 3 half-lives since previous monoclonal antibody therapy
Subject has received investigational therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study drug.
Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of talazoparib and during the study
Patient is using drugs (or has medical conditions) that are generally accepted to have a risk of causing torsades de pointes (TdP) patients who have discontinued any of these medications must have a wash-out period of at least 5 days or 5 half-lives of the drug (whichever is greater) prior to the first dose of AC480IV
Received an investigational drug within 14 days or 5 half-lives, whichever is shorter, of the first scheduled dose of MEDI7247 or not recovered from associated toxicities.
Prior treatment with the following therapies: • Anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered. • Part 2B (GSK3359609/pembrolizumab combination): prior pembrolizumab washout is not required. • Prior radiation therapy: permissible if at least one non-irradiated measurable lesion is available for assessment according to RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. A wash out of at least two weeks before start of study drug for radiation of any intended use to the extremities for bone metastases and 4 weeks for radiation to the chest, brain, or visceral organs is required. • Investigational therapy within 30 days or 5 half-lives of the investigational product (whichever is shorter). At least 14 days must have elapsed between the last dose of investigational agent and the first dose of study drug is administered.
Have received prior systemic anti-cancer therapy (including abiraterone) or investigational therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first administration of study drug
Anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal or any investigational therapy within 14 days or 5 half-lives (whichever is shorter) prior to first dose of study drug
Male subjects who are unwilling to use contraception during the treatment and for at least 31 weeks after the last dose of study treatment (5 half-lives of study drug plus 90 days duration of sperm turnover)
Treatment with other non-cytotoxic agents for NSCLC in the preceding ten days or four terminal half-lives, whichever is shorter
Patient has received chemotherapy, monoclonal antibodies or targeted anticancer therapy =< 4 weeks or 5 half-lives, whichever is shorter, or 6 weeks for nitrosourea or mitomycin-C prior to starting the study drug, or the patient has not recovered from the side effects of such therapy
Patient who lives alone
Administered a radioisotope ? 5 physical half-lives prior to the date of study PET/CT
Lives in Guam or Saipan
Use of an investigational drug within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug. Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drug.
Prior systemic cancer-directed treatments or investigational modalities ? 5 half lives or 4 weeks prior to starting study drugs, whichever is shorter.
Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of trametinib and during the study
Participants receiving any systemic chemotherapy, radiotherapy, or targeted anti-cancer therapy within 2 weeks or 3 half-lives from the last dose prior to study treatment (or a longer period depending on the half-life of the agents used); the patient can receive bisphosphonates or steroids
Experimental agents within 4 weeks of leukapheresis unless no response or disease progression is documented on the experimental therapy and at least 3 half-lives have elapsed prior to leukapheresis.
Receipt of radioisotope within 5 physical half-lives prior to trial enrollment
Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide
Administered a radioisotope within 10 physical half-lives prior to study drug injection
Administered a radioisotope =< 5 physical half-lives prior to the day of PET/CT
Administered a radioisotope within 5 physical half-lives prior to study enrollment
Patient must not have had any anti-neoplastic biologic agent =< 7 days prior to entry onto this study (or at least 3 half-lives for biologic agents with a long half-life)
Use of any investigational drug within 28 days or five half-lives, whichever is shorter, prior to the first dose of study medication; a minimum of 10 days between termination of the investigational drug and treatment with study medication is required
Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to first dose of study treatment.
Treatment with systemic immunostimulatory agents (including but not limited to interferons or IL-2) within 4 weeks or five half-lives of the drug (whichever is shorter) prior to randomization
No chemotherapy treatments within at least 3 weeks prior to first dose of study treatment. For all prior anticancer treatment, including radiotherapy or targeted agents or hormonal therapy, a duration of more than 5 half-lives of the targeted/hormonal agents used must have elapsed, and any encountered toxicity must have resolved to levels meeting all the other eligibility criteria.
Received investigational therapy with another drug or biologic within 30 days prior to the start of CMP-001 dosing on W1D1. However, if an investigational drug has a short half-life, a shorter wash out period may be acceptable upon permission given by the Sponsor.
Subject has received any of the following within 14 days or 5 drug half-lives (whichever is shortest) prior to the first dose of chemotherapy, or has not recovered to less than grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy\r\n* Any anti-cancer therapy including chemotherapy, biologic agents for antineoplastic treatment (e.g. monoclonal antibodies) or radiotherapy, investigational therapy, including targeted small molecule agents
4 weeks or 3 half-lives since prior antibody-based therapy, whichever is shorter
The following time periods must have elapsed prior to start of study treatment, the following time periods must have elapsed:\r\n* 5 half-lives from any investigational agent\r\n* 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas)\r\n* 6 weeks from antibodies\r\n* Prior treatment with other immune modulating agents within fewer than 4 weeks prior to the first dose of avelumab\r\n** Examples of immune modulating agents include blockers of CTLA-4, 4-1BB (CD137), OX-40, therapeutic vaccines, or cytokine treatments\r\n* 4 weeks (or 5 half-lives, whichever is shorter) from other anti-tumor therapies
Treatment with anticancer therapy or investigational drug or device within 3 wk (6 wk for nitrosureas or mitomycin C) or 5 half-lives of agent, whichever is shorter, prior to first drug dose, and any drug-related toxicities must have recovered to grade 1 or less
Systemic anti-cancer therapy completed within a minimum of 5 half-lives of study entry
Administered a radioisotope within 5 physical half lives prior to study enrollment
Receipt of radioisotope within 5 physical half lives prior to trial enrollment
Administration of a radionuclide within 5 physical half-lives prior to projected administration of 124I-A11 PSCA minibody
Patients may not have had prior chemotherapy or biologic therapy in the 4 weeks prior to study entry; for patients who have been treated with targeted therapy, 5 half-lives of that therapy (or 28 days, whichever is shorter) must have passed prior to enrollment in the study
Systemic treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 3 weeks before study drug treatment; or treatment with nitrosoureas or mitomycin C within 6 weeks before study drug treatment; or treatment with small-molecule targeted agents within 2 weeks, or 5 half-lives before study drug treatment, whichever is longer.
Any prior systemic therapy (e.g., chemotherapy, molecularly targeted agent, immunotherapy, etc.) or major surgery must have been completed at least 30 days (or as determined by the local requirement, whichever is longer), or at least 5 half lives for drugs with half lives of 6 days or longer prior to initiation of crizotinib treatment. Any prior radiation (except palliative) or minor surgeries/procedures must have been completed at least 2 weeks prior to the initiation of crizotinib treatment. Palliative radiation (? 10 fractions) must have been completed 48 hours prior to the initiation of crizotinib treatment. Any acute toxicity must have recovered to Grade ?1 (except alopecia).
Use of an investigational anti-cancer drug within 28 days or five half-lives, whichever is shorter, prior to the first dose of GSK1120212; a minimum of 10 days between termination of the investigational drug and administration of GSK1120212 is required; in addition, any drug-related toxicity should have recovered to grade 1 or less
Cytotoxic chemotherapy, radiotherapy, or immunotherapy within 4 weeks, or small molecule or investigational agents within 6 elimination half-lives of the first dose of XmAb13676
Prior systemic cancer-directed treatments or investigational modalities ? 5 half lives or 4 weeks prior to starting CC-90009, whichever is shorter. Hydroxyurea is allowed to control peripheral leukemia blasts.
Systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents) or investigational device within 3 weeks or 5 half-lives (if the drug's half-life in subject is known) prior to randomization, whichever is shorter
Prior treatment with investigational agents =<21 days or =<5*their half-lives (whichever is shorter) before the first dose of study treatment. A minimum of 10 days should elapse from prior therapy to initiating protocol therapy.
Systemic antineoplastic therapy (including cytotoxic chemotherapy and toxin immunoconjugates, but excluding hydroxyurea), unconjugated antibody therapy, or radiotherapy within 2 weeks of the first dose of study treatment, or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment.
Patients must have completed any chemotherapy, radiation therapy, surgery, or biologic therapy >= 3 weeks (or >= 5 half-lives, whichever is shorter) prior to entering the study; patients must be >= 2 weeks since any prior administration of a study drug in an exploratory investigational new drug (IND)/phase 0 study and >= 1 week since any palliative radiation therapy; patients must have recovered to eligibility levels from prior toxicity or adverse events
Participants who have received any anticancer treatment within 21 days or any investigational agent within 30 days (or 5 half-lives) prior to the first dose of study drug and should have recovered from any toxicity related to previous anticancer treatment. This does not apply to the use of TSH suppressive thyroid hormone therapy.
Use of any other experimental medication(s) within 14 days or 5 half-lives, but in no case <14 days prior to the start of treatment on Cycle 1, Day 1, except if approved by the Sponsor.
Major surgery, chemotherapy, systemic therapy (excluding hydroxyurea,steroids and any targeted small molecules or biologics), or radiotherapy, within 14 days or 5 half-lives (whichever is shorter) prior to the Cycle 1, Day 1 treatment, except if approved by the Sponsor.