Prior therapy for metastatic disease permitted; at least weeks must have elapsed since prior chemotherapy or biological therapy, weeks if the regimen included carmustine (BCNU) or mitomycin C; radiotherapy must be completed at least weeks prior to registration
Systemic anti-cancer therapy within weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity, e.g. mitomycin C and nitrosoureas, weeks washout period. For patients receiving anticancer immunotherapies such as CTLA- antagonists, weeks is indicated as the washout period.
Radiotherapy, unless brief course for palliative therapy, endocrine therapy, target-specific therapy, immunotherapy, or chemotherapy during the weeks ( weeks for nitrosoureas and Mitomycin-C, and weeks for investigational medicinal products) or drug half-lives before first dose of study drug, whichever is greater
Systemic anti-cancer therapy within weeks of the first dose of study treatment; for cytotoxic agents that have major delayed toxicity, e.g. mitomycin C and nitrosoureas, weeks is indicated as washout period; for patients receiving anticancer immunotherapies such as CTLA- antagonists, weeks is indicated as the washout period
Concurrent administration of any other anti-cancer therapy\r\n* Bisphosphonates and denosumab for bone metastases are allowed as long as these were started at least weeks prior to treatment with study drug\r\n* Octreotide is allowed if dose is stable for > months with no worsening of carcinoid syndrome\r\n* Hormonal therapy with luteinizing hormone-releasing hormone (LHRH) analogues for medical castration in patients with castrate-resistant prostate cancer is permitted\r\n* Most recent chemotherapy within weeks prior to entering the study\r\n* Therapeutic radiotherapy within the previous weeks if =< % of their total marrow volume or weeks if > % of their total marrow volume, or unresolved acute or subacute toxicities from prior radiotherapy\r\n* Most recent experimental (non-FDA approved) anti-cancer therapy or immunotherapies =< days or five half-lives of the drug (whichever is less)\r\n* Patients who have not recovered to =< Common Terminology Criteria for Adverse Events (CTCAE) grade toxicities related to prior therapy (administered more than weeks earlier) or incomplete recovery from previous surgery, unless agreed by the principal investigator (PI) and documented are not eligible to participate in this study with the exception of grade peripheral neuropathy if it has been stable, and not worsening, for at least days, and grade alopecia
The following time periods must have elapsed prior to the planned start date of study treatment:\r\n* >= weeks or half-lives from any approved tyrosine kinase inhibitors (TKIs) or investigational agent, whichever is shorter\r\n* >= weeks from prior cytotoxic therapy, except >= weeks from last dose of temozolomide and >= weeks from nitrosoureas or mitomycin C\r\n* >= weeks from non-cytotoxic agents\r\n* >= weeks from bevacizumab
Received chemotherapy, targeted therapies, definitive radiotherapy, or treatment with an investigational anticancer agent within weeks (in the case of nitrosoureas and mitomycin C, within weeks; in the case of immunotherapy, within weeks) before the first administration of study drug. Localized palliative radiation therapy (but should not include radiation to target lesions) and ongoing bisphosphonates and denosumab, are permitted
Had systemic treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within weeks before study drug treatment; or treatment with nitrosoureas or mitomycin C within weeks before study drug treatment; or treatment with small-molecule targeted agents within weeks before study drug treatment. Previous and concurrent use of hormone replacement therapy, the use of gonadotropin releasing hormone modulators for prostate cancer, and the use of somatostatin analogs for neuroendocrine tumors are permitted if such therapy has not been changed within weeks before study drug treatment.
Any prior therapy must have been completed >= weeks ( weeks for nitrosoureas and mitomycin C) or, if known, >= half-lives of the prior agent (whichever is shorter) prior to enrollment on protocol (minimum of week between prior therapy and study enrollment), and the participant must have recovered to eligibility levels from prior toxicity; prior definitive radiation should have been completed >= weeks or palliative radiation should have been completed >= weeks prior to study enrollment and all associated toxicities resolved to eligibility levels; patients must be >= weeks since any investigational agent administered as part of a phase study (where a sub-therapeutic dose of drug is administered) at the principal investigator's (PIs) discretion, and should have recovered to grade or baseline from any toxicities
Participants who have had chemotherapy, immune therapy, or radiotherapy within weeks ( weeks for nitrosoureas or mitomycin C; five-half lives for any investigational or Food and Drug Administration [FDA]-approved kinase inhibitors) prior to entering the study. Patients who have received prior CHK inhibitor therapy are excluded. Exposure to prior PD-L antibody will be allowed as long as this was not the most recent treatment prior to enrollment.
Participants who have had chemotherapy, radiotherapy, biologic therapy, major surgery, or another investigational agent within weeks ( weeks for nitrosoureas or mitomycin C) prior to entering the study. Previous BRAF/MEK inhibitor use is allowed with no washout period for the phase I and II portions
Treatment with cytotoxic or targeted antineoplastics within weeks of initiation of study treatment. For cytotoxic agents that have major delayed toxicity a washout period of one cycle is indicated (examples are nitrosoureas and mitomycin C which typically require a week washout). Prior antibodies or immunotherapies require a week washout.
Participants who have had chemotherapy, other investigational or biologic therapy, major surgery, or radiotherapy within weeks ( weeks for nitrosoureas or mitomycin C) prior to the planned first dose of prexasertib (LY) therapy.
Patients must have completed any chemotherapy, radiation therapy, or biologic therapy >= weeks or half-lives (whichever is shorter) ( weeks for nitrosoureas or mitomycin C) prior to entering the study; patients must be >= weeks since any prior administration of a study drug in a phase or equivalent study and be >= weeks since any prior palliative radiation or cyberknife therapy; patients must have recovered to grade from prior toxicity or adverse events; patients with bone metastases or hypercalcemia on intravenous bisphosphonate treatment prior to study entry may continue this treatment
Patients must be at least weeks from previous therapy (chemotherapy, hormonal therapy, and radiation therapy, or investigational agents; weeks for mitomycin C)
Chemotherapy, radiation therapy, or immunotherapy within weeks prior to first dosing of study drug ( weeks for nitrosoureas); concomitant hormonal therapies for breast cancers are allowed
Patients who are currently receiving systemic cytotoxic chemotherapy, radiation, targeted molecular therapy (e.g. vemurafenib, other inhibitor of mutant BRAF, MEK, or cKit), or other experimental therapy, or who have received this therapy within the preceding weeks (except as specified). Gamma knife or stereotactic radiosurgery may be administered within the prior weeks, but must not be administered less than one week prior to study registration. Patients who are currently receiving nitrosoureas or who have received this therapy within the preceding weeks are excluded.
Anticancer chemotherapy or immunotherapy during the study or within -halflives prior to start of study treatment. Mitomycin C, nitrosoureas or monoclonal antibodies with anticancer activity (e.g. bevacizumab or cetuximab etc.) should not be given within weeks before starting to receive study treatment or within weeks of pre-treatment biopsy for biomarker (p-ERK/) studies
Patients must have completed any chemotherapy, radiation therapy, or biologic therapy >= weeks (or half-lives, whichever is shorter) prior to entering the study ( weeks for nitrosoureas or mitomycin C); patients must be >= weeks since any prior administration of a study drug in a phase or equivalent study and >= week from palliative radiation therapy; patients must have recovered to eligibility levels from prior toxicity or adverse events; treatment with bisphosphonates is permitted
Patients may not be receiving any other investigational agents during protocol therapy, or up to days prior to beginning protocol therapy; there should be a least a -week interval between last dose of endocrine therapy and protocol therapy, and at least weeks for the last dose of biologic therapy (eg, bevacizumab) or cytotoxic therapy (or weeks for capecitabine or weekly paclitaxel, weeks for mitomycin-C and nitrosoureas), and adequately recovered from adverse effects from prior therapy to meet all other eligibility criteria
Time from prior therapy:\r\n* Systemic anti-neoplastic therapy: five half-lives or four weeks, whichever is shorter ( weeks for nitrosoureas or mitomycin C)\r\n* Hormonal therapy is not considered anti-neoplastic therapy\r\n* Radiotherapy: wide-field radiotherapy (e.g. > % of marrow-bearing bones) completed at least four weeks, or focal radiation completed at least two weeks, prior to starting study treatment
Prior therapeutic intervention with any of the following:\r\n* Nitrosoureas or mitomycin C within weeks\r\n* Therapeutic anticancer antibodies (including rituximab) within weeks\r\n* Radio- or toxin-immunoconjugates within weeks\r\n* All other chemotherapy, radiation therapy within weeks prior to initiation of therapy
Cytotoxic chemotherapy within weeks of investigational product ( weeks for mitomycin C or nitrosoureas) if immediate prior regimen was administered on an every week schedule or weeks of investigational product if immediate prior regimen consisted of weekly therapy.
Major surgery, radiation therapy or systemic anti-cancer therapy within weeks of study drug administration ( weeks for mitomycin C or nitrosoureas). Palliative radiotherapy to a limited field is allowed after consultation with the medical monitor at any time during study participation, including during screening, unless its clearly indicative of disease progression. For Arm G, subjects who require extended field radiation therapy will be excluded.
Excluded therapies and medications for cancer\r\n* Anticancer chemotherapy or immunotherapy during the study or within weeks of study enrollment; subjects must have recovered from the toxic effects of the previous anti-cancer chemotherapy or immunotherapy (with the exception of alopecia); anti-cancer therapy is defined as any agent or combination of agents with clinically proven anti-tumor activity administered by any route with the purpose of affecting the malignancy, either directly or indirectly, including palliative and therapeutic endpoints; however, subjects with prostate cancer who are receiving depot luteinizing hormone-releasing hormone (LHRH) agonist therapy may continue on this treatment\r\n* Hormonal therapy during the study or within weeks of first study enrollment\r\n* Radiotherapy to target lesions during study or within weeks of first study treatment\r\n* An irradiated lesion is considered evaluable only if it has shown enlargement since the completion of last radiation\r\n* Bone marrow transplant or stem cell rescue\r\n* Bisphosphonate therapy during the first cycles of treatment\r\n* Granulocyte colony stimulating factor (G-CSF) and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the principal investigator; however they may not be substituted for a required dose reduction; erythropoietins are not permitted\r\n* Investigational drug therapy outside of this trial during or within weeks of first study treatment
Major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within weeks prior to the first dose of the study drugs and/or monoclonal antibody =< weeks prior to first administration of study treatment
Prior anti-cancer therapy (e.g., biologic or other targeted therapy, chemotherapy) within days ( weeks for nitrosoureas or mitomycin C, and days for hormonal therapy or kinase inhibitors) before the first dose of study treatment on Study Day of Period A.
REGORAFENIB EXCLUSION CRITERIA: Prior treatment with the following anti-neoplastic therapies within the following time frame:\r\n* Any prior treatment with regorafenib\r\n* Radiotherapy within weeks prior to enrollment\r\n* Receipt of any cytotoxic chemotherapy, biologic agent, or investigational agent within weeks prior to the first dose of study drug (within weeks for nitrosoureas, mitomycin C or liposomal doxorubicin)
Anti-cancer therapy, such as chemotherapy, immunotherapy, targeted and hormonal/endocrine therapy, or investigational agents within two weeks for oral drugs, four weeks for intravenous drugs, and six weeks for nitrosoureas, mitomycin C, or bevacizumab prior to administration of the first dose of study drug
No chemotherapy, immunotherapy, hormonal therapy, or biological therapy for cancer, radiotherapy, or surgical procedures (except for minor surgical procedures) within four weeks before beginning treatment with SB- (six weeks for nitrosoureas and mitomycin C); subjects must have recovered at least to grade from toxicities (incurred as a result of previous therapy) sufficiently to be entered into a Phase I study
Relapsed/refractory MCL: Prior chemotherapy within weeks, nitrosoureas within weeks, therapeutic anticancer antibodies within weeks, radio- or toxin-immunoconjugates within weeks, radiation therapy or other investigational agents within weeks, major surgery within weeks or vaccination with live attenuated vaccines within weeks of the first dose of study drug
Patient who has had radiotherapy within week (or unresolved radiation-related toxicities), chemotherapy within weeks or half-lives, whichever is longer ( weeks for nitrosoureas, mitomycin C or bevacizumab), anti-cancer monoclonal antibody for direct anti-neoplastic treatment within weeks, or who has not recovered from toxicity due to previous agents administered. If the patient has residual toxicity from prior treatment, toxicity must be =< grade (except for neuropathy and alopecia)
Patients who have had chemotherapy or radiotherapy within two weeks, weeks for nitrosoureas, mitomycin C, pegylated-doxorubicin and one half-life for bevacizumab, hormone therapy within one week, trastuzumab within weeks or lapatinib within one week of study day
Received non-biologic anticancer medication within half-lives prior to receiving the first dose of study drug (within weeks for mitomycin-C or nitrosoureas), within days for any antibodies or biological therapies
Patients who have had chemotherapy within weeks ( weeks for nitrosoureas or mitomycin C), anticancer antibodies within weeks, radio or toxin immunoconjugates within weeks, radiation therapy within weeks or major surgery within weeks prior to entering the study\r\n* Palliative (limited-field) radiation therapy is permitted if the patient has additional measurable lesions to assess response of therapy
Patients must have completed radiation therapy or major surgery >= weeks, or biologic therapy or chemotherapy >= half-lives or weeks, whichever is shorter ( weeks for nitrosoureas and mitomycin C) prior to entering the study; patients must be >= weeks since any prior administration of a study drug in a phase or equivalent study and be >= week from palliative radiation therapy; patients must have recovered to eligibility levels from prior toxicity or adverse events; treatment with bisphosphonates is permitted
Prior therapeutic intervention with any of the following:\r\n* Therapeutic anticancer antibodies (rituximab, obinutuzumab) within weeks\r\n* Radio- or toxin-immunoconjugates within weeks\r\n* Inhibitors of PIK (idelalisib), ibrutinib, BH-mimetic venetoclax, lenalidomide, and other targeted therapy (including investigational BTK inhibitors and other investigational therapy) within half-lives\r\n* All other chemotherapy, radiation therapy within weeks prior to initiation of therapy
Prior chemotherapy within weeks, nitrosoureas within weeks, therapeutic anticancer antibodies within weeks, radio- or toxin-immunoconjugates within weeks, radiation therapy or other investigational agents within weeks, major surgery within weeks or vaccination with live attenuated vaccines within weeks of the first dose of study drug.
TREATMENT: Any prior therapy, radiotherapy, or major surgery must have been completed >= weeks (> weeks for nitrosoureas or mitomycin C) or half-lives of the agent (whichever is shorter) prior to enrollment on protocol, and the participant must have recovered to eligibility levels from prior toxicity; radiofrequency ablation (RFA) of localized lesions should have been performed >= weeks prior to treatment
Recent therapeutic intervention including a) prior nitrosoureas or mitomycin C; prior radio- or toxin-immunoconjugates within weeks; b) therapeutic anticancer antibodies (including rituximab, ofatumumab and obinituzumab) within weeks; and c) all other chemotherapy or radiation therapy within weeks prior to initiation of study drug
Patients must have recovered to at least eligibility levels due to adverse events (AEs) and/or toxicity of prior chemotherapy or biologic therapy; they must not have had chemotherapy or biologic therapy within weeks ( weeks for nitrosoureas and mitomycin C, or months for UCN-), or therapy with tyrosine kinase inhibitors within times the half-life of the inhibitors prior to entering the study; patients must be >= weeks since any investigational agent administered as part of a phase study (also referred to as an early phase I study or pre-phase I study where a sub-therapeutic dose of drug is administered) at the principal investigator's (PI) discretion, and should have recovered to eligibility levels from any toxicities
Patients must have recovered to at least a grade =< toxicity eligibility levels due to adverse events (AEs) and/or toxicity of prior chemotherapy or biologic therapy; they must not have had chemotherapy or biologic therapy within weeks ( weeks for nitrosoureas and mitomycin C, or months for UCN-), or therapy with tyrosine kinase inhibitors within times the half-life of the inhibitors prior to entering the study; patients must be >= weeks since any prior administration of study drug in an exploratory investigational new drug (IND)/phase study; patients must be >= month since completion of any prior radiation (>= weeks for palliative radiation therapy); however, patients receiving bisphosphonates for any cancer or undergoing androgen deprivation therapy for prostate cancer are eligible for this therapy\r\n* Prior therapy with topoisomerase I inhibitors is allowed
First day of dosing with tesevatinib is less than weeks from the last treatment of cytotoxic chemotherapy, biological therapy, or immunotherapy, and less than weeks for nitrosoureas and mitomycin C. Surgical procedures must have been performed at least weeks prior to the start of study treatment. Subjects must have recovered from the reversible effects of prior lung cancer treatments, including surgery and radiation therapy (excluding alopecia)
None of the following therapies are allowed prior to registration:\r\n* Chemotherapy =< weeks\r\n* Immunotherapy =< weeks\r\n* Biologic therapy =< weeks\r\n* Hormonal therapy =< weeks\r\n* Monoclonal antibodies =< weeks\r\n* Radiation therapy =< weeks\r\n* Anti-Her- or other targeted (e.g. mammalian target of rapamycin [mTOR]) therapy =< weeks\r\n** NOTE : Any toxicities derived from these therapies must be =< grade prior to starting study therapy
Prior treatment (chemotherapy [chemo], radiation, hormone, and immune therapies) must be completed > weeks prior to randomization (> weeks prior to randomization for nitrosoureas, mitomycin C, and checkpoint inhibitors)
Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within weeks ( weeks for nitrosoureas) prior to start of study treatment. Biologic, novel therapy (including investigational agents in this class) or corticosteroids within weeks prior to patient registration. Patient has side effects of the previous therapy > grade or previous baseline.
Treatment with cytotoxic or biologic agents within the weeks prior to beginning treatment on this study ( weeks for mitomycin or nitrosoureas); at least weeks must have elapsed from any prior surgery, radiation, hormonal or other drug therapy for their cancer
At least weeks must have elapsed since the last chemotherapy, targeted therapy, immunotherapy, radiotherapy, liver-directed therapy, or major surgery. At least weeks for nitrosoureas, mitomycin C and liposomal doxorubicin. If started before T-cell administration, ipilimumab infusions must be least days apart.
Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents within days of starting study treatment (not including palliative radiotherapy at focal sites); prior use of an investigational monoclonal antibody therapy within months, or prior use of nitrosoureas or mitomycin C within weeks; patients must have recovered from acute toxicity due to radiotherapy
A sufficient interval must have elapsed between the last dose of prior anti-cancer therapy (including cytotoxic and biological therapies and major surgery) and enrollment: a) cytotoxic or targeted chemotherapy: greater than or equal to the duration of the cycle of the most recent treatment regimen (a minimum of weeks for all regimens, except weeks for nitrosoureas and mitomycin-C); b) biologic therapy (e.g., antibodies): greater than or equal to weeks
Patients may have been treated with cytotoxic, biologic (antibody), immune or experimental therapy, tyrosine kinase inhibitors, hormone inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs) provided this has been completed at least weeks prior to registration ( weeks for mitomycin and nitrosoureas) and recovered from any therapy related toxicity to less than CTCAE grade
Major surgery, radiation therapy, or systemic anti-cancer therapy within weeks of study treatment start ( weeks for mitomycin C or nitrosoureas)
Patients must have completed any chemotherapy, radiation therapy, biologic therapy, or major surgery >= weeks prior to enrollment ( weeks for nitrosoureas or mitomycin C); patients must be >= weeks since any prior administration of a study drug in a phase or equivalent study, at the discretion of the principal investigator; patients must have recovered to eligibility levels from prior toxicity or adverse events; patients with bone metastases or hypercalcemia on intravenous (IV) bisphosphonate treatment prior to study entry may continue this treatment
Previous anti-cancer chemotherapy, immunotherapy or investigational agents < weeks ( weeks for nitrosoureas or mitomycin C) prior to the first day of study defined treatment; palliative radiation < weeks, biological therapy within weeks, hormonal therapy within week prior to day cycle
Patient has had any treatment specific for tumor control within weeks of dosing with investigational drugs and cytotoxic agents, or within weeks of cytotoxic agent given weekly, or within weeks of nitrosoureas or mitomycin C, or within half-lives of biological targeted agents
Patients must have recovered to =< grade Common Terminology Criteria for Adverse Events (CTCAE) version (v) from toxicity of prior chemotherapy or biologic therapy and must not have had prior chemotherapy or biologic therapy within weeks ( weeks for nitrosoureas or mitomycin C, weeks for -hydroxystaurosporine [UCN-])
Prior and concurrent therapy:\r\n* Chemotherapy: At least four weeks since prior cytotoxic chemotherapy or weeks since nitrosoureas or mitomycin\r\n* Molecular targeted agents including monoclonal antibodies and tyrosine kinase inhibitors: At least two weeks since last therapy\r\n* Endocrine therapy: Subject may be remain on luteinizing hormone-releasing hormone (LHRH) antagonist therapy for prostate cancer if tumor progression has been confirmed\r\n* Radiotherapy: At least weeks since most recent radiotherapy\r\n* Palliative radiotherapy to localized painful lesions is acceptable when the subject is on study: At least one week after completion of radiation therapy (RT) and recovery from associated toxicities before restarting ARQ ; irradiated lesions will not be evaluable for response\r\n* Other investigational therapy: At least four weeks since any other investigational therapy\r\n* Concurrent therapy: No other concurrent anticancer or investigational therapy permitted except as noted above
Patients must have recovered from the toxic effects of prior therapy including but not limited to: \r\n* An interval of >= weeks ( days) from prior cytotoxic therapy except weeks from nitrosoureas\r\n* An interval of >= week ( days) from any non-cytotoxic agents\r\n* An interval of >= months from the completion of radiation therapy
Patients must have recovered to at least eligibility levels following any display of adverse events and/or toxicity due to prior chemotherapy or biologic therapy; they must not have had hormonal therapy, chemotherapy or biologic therapy within weeks prior to entering the study ( weeks for nitrosoureas or mitomycin C, or -hydroxystaurosporin [UCN-]); patients must be >= weeks since any prior administration of study drug in a phase study (also referred to as an early phase I study or pre-phase I study where a sub-therapeutic dose of drug is administered) at the principal investigator's (PIs) discretion; patients must be >= weeks since any prior radiation or major surgery; however, patients receiving bisphosphonates or therapeutic anticoagulation are eligible for this trial
At least weeks since the last dose of chemotherapy, immunotherapy, surgery, or radiation therapy (exception: patients may have received palliative low dose radiation therapy one week before treatment provided it is not given to the only targeted lesions); at least weeks for therapy which is known to have delayed toxicity (nitrosoureas, mitomycin-C, and liposomal doxorubicin); at least weeks (or half-lives, whichever is shorter) since treatment with biologic/targeted therapies; at least weeks since last hormonal therapy
Any prior therapy must have been completed >= weeks prior to enrollment on protocol and the participant must have recovered to eligibility levels from prior toxicity; patients should be at least six weeks out from nitrosoureas and mitomycin C; prior radiation should have been completed >= weeks prior to study enrollment and all associated toxicities resolved to eligibility levels; patients must be >= weeks since any investigational agent administered as part of a phase study (also referred to as an early phase I study or pre-phase I study where a sub-therapeutic dose of drug is administered) at the PIs discretion, and should have recovered to eligibility levels from any toxicities
Any prior therapy must have been completed >= weeks prior to enrollment on protocol and the participant must have recovered to eligibility levels from prior toxicity; patients should be at least weeks out from nitrosoureas and mitomycin C; prior radiation should have been completed >= weeks prior to study enrollment and all associated toxicities resolved to eligibility levels; patients must be >= weeks since any investigational agent administered as part of a phase study (also referred to as an early phase I study or pre-phase I study where a sub-therapeutic dose of drug is administered) at the principal investigator's (PIs) discretion, and should have recovered to eligibility levels from any toxicities
Prior anti-tumor therapy including (all times measured prior to start of study drug): nitrosoureas within weeks, chemotherapy within weeks, therapeutic antibodies within weeks, radio- or toxin-immunoconjugates within weeks, radiation therapy within weeks, investigational agents within weeks, unless antibody this should be within weeks
Patients must be >= weeks from cytotoxic chemotherapy, except >= weeks for mitomycin C or nitrosoureas, and >= weeks from prior -hydroxystaurosporine (UCN); >= weeks from monoclonal antibody therapy (cetuximab, bevacizumab); >= weeks from prior experimental therapy; >= weeks from radiation or hormonal therapy; >= weeks from sorafenib, sunitinib or temsirolimus treatment; patients with prostate cancer may continue ongoing luteinizing hormone-releasing hormone (LhRH) agonist therapy; patients with bone metastases or hypercalcemia who began intravenous bisphosphonate treatment prior to study entry may continue this treatment while on study
Prior chemotherapy within weeks, nitrosoureas (carmustine) within weeks, therapeutic anticancer antibodies within weeks, radio- or toxin-immunoconjugates within weeks, radiation therapy within weeks, or major surgery within weeks of first dose of study drug
Major surgery, radiation therapy, or systemic anti-cancer therapy within weeks of study treatment start ( weeks for mitomycin C or nitrosoureas)
Completed prior chemotherapy a minimum of weeks previously ( weeks for BCNU and/or mitomycin C), weeks for prior immune therapy, weeks for antibodies to checkpoints CTLA, PD, PDL, etc, and weeks for targeted agents (i.e. inhibitors of MEK, BRAF, Akt, PIK, mTORC/) or localized radiation therapy; all treatment related toxicity must have resolved to grade or less or to a baseline level as well
No radiation, major surgery, chemotherapy or biologic therapy within weeks prior to entering the study ( weeks for nitrosoureas or mitomycin C); >= weeks since any prior administration of study drug in an exploratory investigational new drug (IND)/phase study (also referred to as an early phase I study or pre-phase I study where a subtherapeutic dose of drug is administered) at the principal investigator (PI)s discretion; patients must have recovered to at least eligibility levels due to adverse events and/or toxicity of prior chemotherapy or biologic therapy
Any concurrent chemotherapy, biologic, hormonal, radiation, or investigative therapy for cancer treatment within days prior prior or within weeks prior to Cycle /Visit Day for nitrosoureas or mitomycin C;
Systemic antineoplastic therapy or any experimental therapy within weeks before the first dose of study drug ( weeks for prior nitrosoureas, bevacizumab, or mitomycin C)
Patients must have recovered (grade or baseline) from any clinically significant toxicity associated with prior therapy; typically, this is weeks for patients who most recently received cytotoxic therapy, except for the nitrosoureas and mitomycin C, for which weeks is needed for recovery
Following treatment-free period prior to enrollment to the study: i)Surgery: weeks for major surgery (e.g., laparotomy and thoracotomy); weeks for less extensive surgery (e.g., colostomy) ii)Radiation: weeks ( weeks for palliative irradiation to bone metastases [except for pelvic irradiation], and brain metastasis) iii) Chemotherapy (including systemic treatment with anticancer therapy and retinoid therapy): weeks ( weeks for nitrosourea antineoplastic agent and mitomycin C) iv) Antibody-based therapy: weeks v) Small molecule targeted agents: If myelosuppression is not expected, weeks or half-lives, whichever is longer; otherwise, weeks vi) Hormonal treatment: weeks. Previous and concurrent use of hormone replacement therapy, the use of gonadotropin-releasing hormone modulators for prostate cancer, and the use of somatostatin analogs for neuroendocrine tumors are permitted if such therapy has not been changed within weeks before study drug treatment. vii) Pleurodesis: weeks
Antitumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, or hormonal therapy) within weeks prior to administration of the investigational product (IP) ( weeks for nitrosoureas and mitomycin C). Any previous treatment-related toxicities must have recovered to Grade ? (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.). Prior and concurrent use of hormone deprivation therapies for hormone-refractory prostate cancer or breast cancer are permitted.
Prior therapy requirements: \r\n* At least >= prior completed chemotherapy regimen including chemotherapy, biologic, immunologic or targeted therapy\r\n* At least weeks from last dose of prior chemotherapy with resolution of the acute toxic effects of the therapy\r\n* At least weeks from completion of prior radiation therapy\r\n* At least weeks from last dose of prior investigational therapy\r\n* Not receiving any current anti-cancer therapy\r\n* At least weeks from last dose of interferon or IL- therapy\r\n* At least weeks from completion of antibody therapy with anti-checkpoint antibodies, such as anti-cytotoxic T-lymphocyte-associated protein (CTLA) and anti-programmed cell death (PD)\r\n* At least weeks from last dose of prior other biologic agents
Chemotherapy, targeted therapies, radiotherapy, immunotherapy, or treatment with an investigational anticancer agent within weeks or at least half-lives of the drug, whichever is longer and up to a maximum of weeks (in the case of nitrosoureas and mitomycin C within weeks) before the first administration of study drug. Localized radiation therapy and ongoing luteinizing hormone-releasing hormone (LHRH) agonists, bisphosphonates and denosumab, are permitted
All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least weeks prior to treatment in this study; a minimum of weeks treatment break is required in case of nitrosoureas or mitomycin C
Any prior chemotherapy therapy is allowed in this protocol; no more than prior cytotoxic chemotherapy regimens are allowed for eligibility; non-myelotoxic therapies such as sunitinib and sorafenib or everolimus are not considered \cytotoxic chemotherapies\; patients must be >= weeks from prior radiation or cytotoxic chemotherapy, except >= weeks for mitomycin C and nitrosoureas; >= weeks from hormonal therapy; >= weeks from prior experimental therapy; >= weeks from monoclonal antibody therapy (cetuximab, bevacizumab), >= weeks from sorafenib, sunitinib or temsirolimus and >= weeks from prior -hydroxystaurosporine (UCN) treatment; patients with prostate cancer may continue ongoing luteinizing hormone-releasing hormone (LHRH) agonist therapy; patients with bone metastases or hypercalcemia who began intravenous bisphosphonate treatment prior to study entry may continue this treatment
Chemotherapy, radiation therapy, or immunotherapy within weeks prior to first dosing of study drug ( weeks for nitrosoureas); concomitant hormonal therapies for breast cancers are allowed
Received the last administration of an anticancer monoclonal antibody, immunotherapy, hormonal therapy, or chemotherapy (except nitrosoureas and mitomycin-C) =< days prior to study registration or who have not recovered from the side effects of such therapy
Patient is currently receiving or has received within the last month prior to Cycle Day ( weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin) other chemotherapeutic, hormonal, or investigational anti-cancer agents with the exception of gonadal suppression agents and bisphosphonates for osteoporosis and skeletal metastases which may be continued while on study
At least weeks since the last dose of chemotherapy, immunotherapy, surgery, or radiation therapy (exception: patients may have received palliative low dose radiation therapy one week before treatment provided it is not given to the only targeted lesions); at least weeks for therapy which is known to have delayed toxicity (nitrosoureas, mitomycin-C, and liposomal doxorubicin); at least weeks (or half-lives, whichever is shorter) since treatment with biologic/targeted therapies; at least weeks since last hormonal therapy
Patients who have had (prior to entering the study): major surgery and biologic/antibody therapies (including immunotherapies) are not permitted within weeks of romidepsin administration; anti-cancer therapy including chemotherapy, radiotherapy, hormonal (with the exception of hormones for thyroid conditions), and other investigational agents will not be allowed within days or five () half-lives (whichever is longer) prior to the first dose of romidepsin ( weeks for nitrosoureas or mitomycin C); additionally, participants must have recovered to less than grade clinically significant adverse effect(s)/toxicity(ies) of the previous therapy, with the exception of alopecia, unless approved by the principal investigator
Systemic treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within weeks before study drug treatment; or treatment with nitrosoureas or mitomycin C within weeks before study drug treatment; or treatment with small-molecule targeted agents within weeks, or half-lives before study drug treatment, whichever is longer.
Wash-out periods: at least three weeks since the last anticancer therapy, including radiation therapy (RT) in more than % of the bone marrow; at least three weeks since the last biological/investigational therapy [excluding monoclonal antibodies (MAbs)]; at least four weeks since the last MAb-containing therapy; and at least six weeks since nitrosoureas and mitomycin C (systemic). In the case of hormonesensitive breast cancer progressing while on hormone therapy, the latter must be either stopped up to one week before or continued without changes during the trial.