Anti-cancer chemotherapy or biologic therapy if administered prior to the first planned dose of study medication (napabucasin or FOLFIRI) within period of time equivalent to the usual cycle length of the regimen. An exception is made for oral fluoropyrimidines (e.g. capecitabine, S-), where a minimum of days since last dose must be observed prior to the first planned dose of study medication. Standard dose of bevacizumab ( mg/kg) may be administered prior to FOLFIRI infusion, per Investigator decision, for as long as permanent decision to include or exclude bevacizumab is made prior to patient randomization. Radiotherapy, immunotherapy (including immunotherapy administered for non-malignant diseaseneoplastic treatment purposes), or investigational agents within four weeks of first planned dose of study medication, with the exception of a single dose of radiation up to Gy (equal to RAD) with palliative intent for pain control up to days before randomization.
Prior therapy\r\n* Patients =< days from the last dose of cytarabine used for treatment of TMD
All Cohort A Dose Escalation Participants:\r\n* Prior hormonal therapy: Participants may have received any number of previous endocrine / hormonal lines of therapy in the metastatic setting (including prior fulvestrant), as long as the last dose is >= days prior to first dose of study treatment\r\n* Prior biologics / investigational therapy: Prior therapy with biologics and investigational drugs is allowed, as long as the last dose is >= days prior to first dose of study treatment\r\n* Prior CDK/ inhibition is allowed; participants who have had prior ribociclib must have received treatment at full-dose without any dose reductions; the last dose is required to be >= days prior to first dose of study treatment\r\n* Treatment with prior PD/PDL/CTLA inhibitors is prohibited\r\n* Prior radiotherapy: Participants may have received radiotherapy for palliative purposes but must have completed treatment ? days prior to first dose of study treatment and not be experiencing grade > treatment-related toxicities\r\n* Evaluable or measurable disease by RECIST .
Cohort B Safety Run-In (Ribociclib + PDR + Fulvestrant): Prior CDK/ inhibition is allowed; participants who have had prior ribociclib must have received treatment at full-dose without any dose-reductions; the last dose is required to be >= days prior to first study treatment
Expansion Cohort B (Ribociclib + PDR + Fulvestrant): Prior chemotherapy:\r\n* Participants may have received up to one prior line of chemotherapy for advanced breast cancer as long as the last dose is >= days prior to first dose of study treatment
Any chemotherapy within the days prior to the first dose of study drug.
Tamoxifen and aromatase inhibitors within days prior to the first dose of study drug.
Fulvestrant within days prior to first dose of study drug.
Immunomodulating agents < days prior to first dose of study drug
Treatment with antibiotics within days prior to first dose of study drug.
Neurological stability for at least days prior to first dose of study drug;
Patients must not have received any vaccines for days prior to administration of their first dose of MT- and should not receive any vaccine during the study or within days after their last dose of MT-.
Female subjects who are breastfeeding, or intend to breastfeed during the duration of the study and for days following the last dose of study drug.
Patients who have had chemotherapy within weeks prior to first dose of study drug.
CLL therapy, with the exception of ibrutinib within the following timeframes:\r\n* Chemotherapy, external beam radiation therapy, anticancer antibodies within days prior to the first dose of drug on this study\r\n* Corticosteroid use >= mg prednisone within week prior to first dose on this study\r\n* Radio- or toxin-conjugated antibody therapy within weeks prior to first dose on this study\r\n* Allogeneic stem cell transplant within months prior to first dose on this study
Received hydroxyurea therapy within days ( weeks) before the first dose of any study drug
Last dose of any prior therapy administered by the following time intervals before the first dose of study drug:
The most recent dose of olaratumab must have been received within days of randomization in this study.
Non-oncology vaccines within days prior to or after any dose of ipilimumab
Subject has no significant worsening in clinical status for a minimum of days prior to first dose of study drug.
Participants must have discontinued EGFR targeted therapy prior to the first dose of study drug.
The following restrictions apply to current or prior anti-cancer treatment, prior to the first dose of study drug:\r\n* Patients who are actively receiving any other investigational agents\r\n* Any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within weeks prior to the first dose of study drug\r\n* Radio- or toxin-immunoconjugates within weeks prior to the first dose of study drug\r\n* Previous treatment with greater than one of the study agents (i.e., venetoclax, ibrutinib, obinutuzumab or Revlimid), excluding prior prednisone or rituximab treatment\r\n* Prior allogeneic stem cell (or other organ) transplant within months or any evidence of active graft-versus-host disease or requirement for immunosuppressants within days prior to first dose of study drug\r\n* Not recovered (i.e., =< grade or baseline) from adverse events due to previously administered anti-cancer treatment, surgery, or procedure; NOTE: exceptions to this include events not considered to place the subject at unacceptable risk of participation in the opinion of the principal investigator (PI) (e.g., alopecia)
Within days of the first dose of study drug: Platelets >= ,/L
Anti-cancer therapy less than days prior to the first dose of study drug (less than days for bevacizumab) or palliative, focal radiation therapy less than days prior to the first dose of study drug
Cytotoxic chemotherapy last dose must have been received at least days prior to enrollment, their last dose of biological therapy, immunomodulatory agents, vaccines, differentiating agents, used to treat their cancer at least days prior to enrollment, their last dose of a monoclonal antibody at least days prior to enrollment, and their last dose of any investigational agent at least days prior to enrollment
Patients previously treated with regorafenib, lonsurf or capecitabine as the last prior regimen can start on this study as long as there is at least week of period between the last dose of previous treatment and day in this study provided the patients are eligible; patients who were on FOLFOX or FOLFIRI regimens must have at least weeks period between the last dose and the first dose in this clinical study; patients previously treated with Avastin, Zaltrap, cetuximab, pembrolizumab, panitumumab, nivolumab Erbitux, and Vectibix must have at least weeks period between the last dose of previous chemotherapy and the first dose in this clinical study
Anti-cancer therapy less than weeks prior to the first dose of study drug (less than days for bevacizumab) or palliative, focal radiation therapy less than days prior to the first dose of study drug
Prior chemotherapy or radiotherapy within days prior to first dose of therapy provided subject has received no growth factor support of any kind within days prior to first dose of therapy, otherwise prior chemotherapy within days prior to first dose of therapy
Anti-cancer therapy less than days prior to the first dose of study drug or palliative, focal radiation therapy less than days prior to the first dose of study drug
Patients who have received systemic corticosteroids within days prior to the first dose of study drug
Patients who have received systemic nonsteroidal antiinflammatory drug (NSAID) therapy within days prior to the first dose of study drug
Prior somatostatin analogue therapy; (patients should receive the first dose of study drug no sooner than weeks from the last dose of somatostatin analogue)
Major surgeries (eg, abdominal laparotomy) within weeks of the first dose of study drug. Following major surgeries, > weeks prior to the first dose of study drug, all surgical wounds must be healed and free of infection or dehiscence.
Has completed prior therapies according to the criteria below:\r\n* Cytotoxic chemotherapy - at least days since last dose prior to first dose of ribociclib\r\n* Small molecule inhibitors - at least days since last dose prior to first dose of ribociclib\r\n* Monoclonal antibodies - at least half-lives since last dose prior to first dose of ribociclib; exception: denosumab for bony metastases is allowable\r\n* Immunotherapy (e.g. tumor vaccines) - at least days since last dose prior to first dose of ribociclib\r\n* Radiation - at least days since last dose prior to first dose of ribociclib
Radiation therapy within days of the first dose of study drug
Recent prior therapy, defined as . Any non-monoclonal anti-cancer therapy within days or half-lives, whichever is longer, prior to the first dose of GSK. Any nitrosoureas or mitomycin C within days prior to the first dose of GSK. Prior therapy with biologic agents (including monoclonal antibodies) is permitted so long as days have elapsed since therapy and all therapy-related AEs have resolved to =< Grade , . Any radiotherapy within days or major surgery within days prior to the first dose of GSK. For subjects in the GBM cohort, subjects must have completed radiation therapy at least days prior to the first dose of GSK. . Anti-androgen therapies for prostate cancer, such as bicalutamide, must be stopped weeks prior to enrollment. Second-line hormone therapies such as enzalutamide or abiraterone should be stopped weeks prior to enrolment. Subjects with prostate cancer should remain on luteinizing hormone releasing hormone (LHRH) agonists or antagonists. Subjects with prostate cancer may also remain on low-dose prednisone or prednisolone [up to milligram (mg)/day] and still be eligible for this study.
Subjects who have had radiation therapy within week prior to first dose of drug
Use of amiodarone within days prior to first dose
PHASE II DOSE EXPANSION IN RECURRENT GBM UNDERGOING RESECTION: A baseline brain MRI must be obtained no more than days (+ working days) prior to study enrollment; the patient must either be on no steroids or a stable dose of dexamethasone no greater than mg a day for at least days prior to entrance onto the study
PHASE II DOSE EXPANSION IN NEWLY DIAGNOSED GBM: A baseline brain MRI obtained no more than days (+ working days) prior to study enrollment on a stable dose of steroids no greater than mg a day of dexamethasone for at least days, is required prior to entrance of a patient onto the study; patients must be registered on the study within weeks of completion of concurrent chemoradiation
Use of amiodarone within days prior to first dose
For subjects on corticosteroids, they must be on a stable dose for days prior to anticipated start of study drug
Radiotherapy (RT) (At least days from last local site RT prior to first dose of tazemetostat/At least days from stereostatic radiosurgery prior to first dose of tazemetostat/At least weeks from craniospinal, ?% radiation of pelvis, or total body irradiation prior to first dose of tazemetostat)
Participants who have received any of the following prior to the first dose of study drug:
If receiving eltrombopag or romiplostim, the dose must have been stable for ? days prior to the first dose of PRTX-
If on steroid-sparing adjunctive immunosuppression with cyclosporine, azathioprine, mycophenolate, or -mercaptopurine, the dose must have been stable for ? days prior to the first dose of PRTX- and must be expected to remain stable through study Day , unless dose reduction is required due to toxicities. Treatment with other cytotoxic agents (e.g. cyclophosphamide, vincristine) are not allowed within three months prior to the first dose of PRTX- .
Less than or equal to (</=) hours between onset of ILI and first dose of study drug
Previous enrollment on another study involving the investigation of veliparib (ABT-), with the exception of receiving a single dose of study drug
Systemic anti-myeloma therapy within < days, or plasmapheresis within days prior to the first dose of study drug.
Patients must be days to weeks out from prior therapy:\r\n* Chemotherapy cytotoxic: At least days since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Chemotherapy nitrosoureas: At least weeks since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Chemotherapy non-cytotoxic (e.g. small molecule inhibitor): At least days or five half-lives, whichever is shorter, since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Monoclonal antibody(ies): At least days since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Immunotherapy: At least days since last dose of chemotherapy prior to first dose of tazemetostat\r\n* Radiotherapy (RT): At least days from last local site RT prior to first dose of tazemetostat\r\n* At least days from stereotactic radiosurgery prior to first dose of tazemetostat\r\n* At least days from craniospinal, > % radiation of pelvis or total body irradiation prior to first dose of tazemetostat
Within days of first dose of study drug: Platelets > x ^/L
Patient has any of the following within days prior to the first dose of study drug:
TREATMENT: Breastfeeding should be discontinued while the patient is on this trial and for days following last dose of study drug
Patients enrolled to the prior treatment arm of the dose escalation cohort must not have received anti-cancer therapy less than days prior to the first dose of study drug or palliative, focal radiation therapy less than days prior to the first dose of study drug
Stable systemic cGVHD medication regimen for seven days prior to study enrollment; dose modifications to maintain therapeutic drug levels of immunosuppressants (i.e. tacrolimus and sirolimus) for the month prior and during the study intervention period are allowed and do not constitute a trial violation
Ability to be off prednisone and other immunosuppressive drugs for at least days before first dose of study drug
Radiotherapy (RT) (At least days from last local site RT prior to first dose of tazemetostat/At least days from stereotactic radiosurgery prior to first dose of tazemetostat/At least weeks from craniospinal, ? % radiation of pelvis, or total body irradiation prior to first dose of tazemetostat)
Immunostimulants within weeks or immunosuppressants within days prior to study drug
Anti-cancer therapy less than days prior to the first dose of study drug or palliative, focal radiation therapy less than days prior to the first dose of study drug.
Last dose of any prior therapy administered by the following time intervals before the first dose of study drug:
Completion of, if applicable, radiotherapy, chemotherapy, antibodies and immunoconjugates including brentuximab vedotin and/or another investigational drug which could interact with this trial not less than weeks (or half-lives of the drug, whichever occurs later) prior to first dose of study drug. Cessation of small molecule tyrosine kinase inhibitors must be at least days prior to first dose of study drug.
Agreement to use contraception during the study and for days after the last dose of ACP- or days after the last dose of pembrolizumab, if sexually active and able to bear or beget children.
Time required between the last dose of the latest therapy and the first dose of study drug:
Use of any of the following within days prior to the first dose of IP:
Contraception is recommended for days prior to starting therapy, while participating in this study, during dose interruptions, and for at least days after discontinuation of ibrutinib, days after discontinuation of lenalidomide, and months after discontinuation of rituximab
Pleurodesis within days prior to first dose of study drug
Agreement to use highly effective forms of contraception during the study and for days after the last dose of ACP , days after the last dose of bendamustine, or months after the last dose of rituximab, whichever is longest.
Any chemotherapy less than days before first dose of study
Currently receiving or has received any intensive chemotherapy within the days prior to the first dose of study drug (day -) (Hydrea or other non-intensive regimens such as decitabine may be used but must stop at least one day prior to the first dose of study drug)
Acceptable laboratory assessment obtained within days prior to the first dose of study drug:
Prior systemic cytotoxic chemotherapy, antineoplastic biological therapy (e.g., cetuximab), major surgery within weeks of the first dose of study drug; received thoracic radiation therapy of > Gy within months of the first dose of study drug; received prior tyrosine kinase inhibitor therapy or completed palliative radiotherapy within days of the first dose of study drug
The first dose of atezolizumab in the crossover arm should be within days of last dose but no less than days from the last dose prior to crossing over
Recent prior therapy, defined as follows: ) Any investigational or Food and Drug Administration (FDA)-approved anti-cancer drug within days or half-lives, whichever is longer, prior to the first dose of GSK. Any nitrosoureas or mitomycin C within days prior to the first dose of GSK. Prior therapy with monoclonal antibodies is permitted so long as days have elapsed since therapy and all therapy-related toxicity has resolved to Grade or less. Note that an investigational drug is defined as a drug without an approved oncologic indication. ) Any radiotherapy within days or major surgery within days prior to the first dose of GSK. ) Anti-androgen therapies for prostate cancer, such as bicalutamide, must be stopped weeks prior to enrollment. Second-line hormone therapies such as enzalutamide, abiraterone, or orteronel should be stopped weeks prior to enrolment. Subjects with prostate cancer should remain on luteinizing hormone releasing hormone (LHRH) agonists or antagonists. Subjects with prostate cancer may also remain on low-dose prednisone or prednisolone (up to milligrams [mg]/day) and still be eligible for this study. ) In addition, any therapy-related toxicity must have resolved to Grade or less, with the exception of alopecia (acceptable at any Grade) and peripheral neuropathy (which must be Grade or less prior to enrollment).
Patients may have had prior chemotherapy or immunotherapy or radiation therapy; all prior therapies must be stopped weeks prior to first dose of study treatment, with the exception of patients who have received ipilimumab, which must be stopped weeks prior to first dose of study treatment; patients are prohibited from receiving live vaccines within days prior to first dose of study treatment
Group C: progression following ceritinib is required and the last dose of ceritinib must be no more than days prior to the first dose of study drug.
Subjects must be neurologically stable for at least days prior to first dose of study drug;
Treatment with any investigational products within days before the first dose of study drug and systemic anticancer therapy within days before the first dose of study drug.
Radioimmunotherapy within weeks before first dose of study drug
Participants must have had their last dose of cytotoxic chemotherapy at least days prior to enrollment, their last dose of biological therapy, such as biological response modifiers (e.g., cytokines), immunomodulatory agents, vaccines, differentiating agents, used to treat their cancer at least days prior to enrollment, their last dose of a monoclonal antibody at least days prior to enrollment, and their last dose of any investigational agent at least days prior to enrollment
The patient has received maintenance dose chemotherapy (e.g., low dose cyclophosphamide) ? days from the first dose of Investigational Product.
Patients who received systemic anti-cancer treatment prior to the first dose of study drug within the following time frames:
Patient who has had chemotherapy, or biological cancer therapy within weeks prior to the first dose of study drug; patient who has had radiation within weeks prior to the first dose of study drug
Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least months after the last dose of atezolizumab, months after the last dose of bevacizumab, or month after the last dose of sorafenib
Except for steroid refractory or intolerant cases, participants must be receiving baseline systemic glucocorticoid therapy for cGVHD at study entry; the dose of steroids must be stable for days prior to starting study drug
At the time of trial enrollment, participants may be receiving one or two other immunosuppressive therapies in addition to glucocorticoids; immunosuppressant doses must be stable for days prior to starting study drug; monoclonal T or B cell antibodies must be discontinued at least days before starting study drug
Any prior therapy for castrate disease is acceptable except prior abiraterone, which is excluded; a minimum washout of days for any other anticancer therapy prior to first dose of study drug is required\r\n* Any other radiotherapy or radionuclide require -day washout prior to first dose of study drug\r\n* Denosumab or zoledronic acid are allowed
Plan to father a child while enrolled in this study or within days after the last dose of study drug.
Subject has received potent CYP A inhibitors within days prior to first dose of study drug or proton pump inhibitors such as omeprazole within days prior to first dose of study drug.
Subject has any of the following within days prior to the first dose of study drug:
Subject has received the following within days prior to the first dose of study drug:
Subject has history of gastrointestinal ulcer within days prior to the first dose of study drug.
For the phase I portion of the study, patients who had received prior therapy with nilotinib should have been able to tolerate the dose equivalent to the starting dose of nilotinib in the dose level at which the patient is being entered; patients who previously received nilotinib but never at the dose being proposed are eligible provided they tolerated the maximum dose they were prescribed with no grade or toxicity not responding to optimal management
Participated in another drug study within days before this one
. Received last dose of prior chemotherapy within ? weeks of first dose of VS-.
Anti-cancer therapy within days prior to the first dose of study-drug treatment in Cycle
surgery, radiation, or immunosuppressants within days prior to planned first dose of study drug,
mitomycin-C or nitrosoureas within days prior to planned first dose of study drug. Note: Patients receiving LHRH agonists or antagonists or antiestrogens or aromatase inhibitors started and at a stable dose for at least days prior to planned first dose of study drug are eligible. Patients are permitted one day cycle of concurrent treatment with hydroxyurea during the study.
Prior hormone therapy is allowed, but last dose must be at least days prior to first dose of MEDI.
Subject has had any of the following within days prior to the first dose of study drug:
Treatment within days prior to Dose with:
Any of the following clinical laboratory results during screening (i.e., within days before the first dose of either study drug):
High-dose chemotherapy within weeks of study drug
Systemic antineoplastic therapy within days before the first dose of study drug
Subject has received aspirin or warfarin within days prior to the first dose of study drug
WCBP must agree to have pregnancy tests monthly (every days for women with irregular cycles) while on study drug and weeks after the last dose of study drug
Participants who have stopped study drug dosing for greater than days
Participants who have received any of the following within the listed time frame, prior to the first dose of study drug
Participants who have received the following within days prior to the first dose of study drug:
Radiation therapy within days of the first dose of study drug
Subject has received a prior EGFR inhibitor within days prior to the first dose of study drug.
Subject has had any of the following within days prior to the first dose of study drug:
Prior anti-cancer therapy within days before the first dose of study drug
Female patients may not be breastfeeding at the first dose of talazoparib and must not breastfeed during study participation through days after the last dose of talazoparib.
At least days since the last chemotherapy or immunotherapy prior to the first dose; at least days since the last radiation prior to the first dose (exception: palliative radiotherapy for pain can be used greater than or equal to (>=) days prior to or after infusion)
The patient has been treated with radio- or toxin-immunoconjugates within days of the first dose of the study drug
For patients on higher than physiological level of corticosteroids, they must have been on a stable dose for week prior to initiating study drug, and the dose should not be escalated over entry dose level, if clinically possible
First dose of study medication must be greater than days from completion of cytotoxic and antibody therapy and less than days from previous therapy
Systemic anti-tumor therapy within days, or plasmapheresis within days prior to the first dose of study drug
Surgical intervention within days prior to the first dose of M administration
CLL therapy, with the exception of ibrutinib within the following timeframes:\r\n* Chemotherapy, external beam radiation therapy, anticancer antibodies within days prior to the first dose of drug on this study\r\n* Corticosteroid use >= mg prednisone within week prior to first dose on this study\r\n* Radio- or toxin-conjugated antibody therapy within weeks prior to first dose on this study\r\n* Allogeneic stem cell transplant within months prior to first dose on this study