More than one line of prior chemotherapy for metastatic or locally advanced disease with the following exception:\r\n* Prior neoadjuvant/adjuvant chemotherapy will not count as line of therapy if completed greater than 12 months prior to initiation of chemotherapy regimen for metastatic or unresectable disease
The patient must have experienced disease progression during or within 4 months after the last dose of chemotherapy for metastatic disease, during or within 6 months after the last dose of adjuvant chemotherapy, or have been intolerant of previous chemotherapy
Patients must have had at least one prior regimen of systemic chemotherapy for metastatic or locally advanced, unresectable disease; patients must have progressed following the most recent therapy; prior treatment with irinotecan is allowed; for patients that received adjuvant chemotherapy: prior treatment for metastatic disease is not required for patient who experienced disease recurrence during or within 6 months of completion of adjuvant chemotherapy; if the patient received one line of adjuvant treatment and had disease recurrence after 6 months of completing chemotherapy, patients will only be eligible after failing one additional line of chemotherapy used to treat the metastatic or locally advanced, unresectable disease; patients who have received >= 3 lines of systemic chemotherapy for metastatic or locally advanced, unresectable disease are not eligible
Patients may have received only one prior chemotherapy regimen for metastatic disease provided treatment was completed >= 3 weeks prior to randomization
Progression on at least one prior systemic chemotherapy for advanced, unresectable or metastatic disease; prior adjuvant or neoadjuvant therapy is not included as prior systemic chemotherapy unless treatment occurred within the 6 months prior to study enrollment
Prior chemotherapy:\r\n* History of prior therapy with trastuzumab and a taxane, separately or in combination, is required\r\n* Patients must have either received one line of prior therapy for metastatic breast cancer, or have developed a disease recurrence during or within 6 months after completing adjuvant therapy\r\n* No prior treatment with T-DM1 is allowed\r\n* Last dose of chemotherapy must be at least 21 days prior to registration
Any prior chemotherapy for castration-resistant disease is not allowed. Previous and/or concurrent treatment with other anti-cancer treatments is permitted. Patients are allowed to be treated with chemotherapy during the duration of the trial. Patients who have received chemotherapy as part of initial androgen deprivation therapy for metastatic castration sensitive disease are eligible.
Biopsy-proven metastatic pancreatic adenocarcinoma with documented radiographic disease progression on or after one or more systemic therapies. Chemotherapy given as part of prior chemoradiation in the setting of non-metastatic pancreatic cancer does not count as a line of therapy. Chemotherapy given for at least 4 months as adjuvant after complete response is considered as a first line therapy.
Participant has received more than one prior chemotherapy regimen for metastatic disease.
Patients may have received adjuvant chemotherapy and up to two prior chemotherapy for metastatic or locally recurrent disease; no prior nab-paclitaxel or mifepristone therapy for metastatic disease will be allowed
Before the first dose of study drug: a) Has received prior systemic cytotoxic chemotherapy for metastatic disease; b) Has received other targeted or biological antineoplastic therapy (e.g., erlotinib, crizotinib, cetuximab) for metastatic disease; c) Has had major surgery (<3 weeks prior to first dose).
Have received at least 1 prior systemic therapy in the metastatic or unresectable disease setting; patients who have recurred within six months of adjuvant chemotherapy are not required to have received an additional line of chemotherapy
Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
Prior chemotherapy for metastatic CRPC; prior neoadjuvant chemotherapy or chemotherapy for metastatic hormone sensitive prostate cancer are allowed so long as this treatment was completed at least 6 months prior to initiation of sipuleucel-T
Only one line of prior systemic treatment for metastatic urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined above), within 12 months of the last dose are considered to have received systemic chemotherapy in the metastatic setting Cohort 1: prior chemotherapy and anti-PD(L)1 [in combination or in maintenance setting] (anti-PD(L)1 alone is allowed only for participants with documented cisplatin ineligibility) and Cohort 2: prior chemotherapy (no prior anti-PD(L)1 treatment)
Must have received at least two one prior line of therapy for mCRPC; a taxane chemotherapy administered for metastatic castration sensitive disease will not count, unless patient develops disease progression within 12 months from the last dose chemotherapy
No prior systemic cancer therapy for recurrent or metastatic disease (except if chemotherapy was part of multimodal treatment completed 6 months prior to enrolment).
Prior or concomitant chemotherapy for metastatic or recurrent disease with the following exceptions:\r\n* Prior chemotherapy for local primary disease is permitted\r\n* Bisphosphonates or receptor activator of nuclear factor kappa-? (RANK) ligand inhibitors are allowed at doses and schedule consistent with the treatment or prevention of osteoporosis
Histologically or cytologically confirmed pancreatic adenocarcinoma with metastasis, who had obtained a best response of at least stable disease (SD) or a partial response (PR) for a period of 2 months with no further shrinkage of ? 20% on scan on their first line of chemotherapy for their advanced metastatic disease. Note: Patients that have had prior chemotherapy as adjuvant or neoadjuvant therapy are permitted.
In dose escalation, patients must have had at least one prior line of chemotherapy for advanced disease or progressed within 6 months of adjuvant therapy (prior chemotherapy and/or anti-EGFR therapy is permitted)
Has pathologically confirmed metastatic pancreatic adenocarcinoma that has progressed after, at least, a first line of standard systemic chemotherapy for the metastatic disease, OR participants with pathologically confirmed metastatic adenocarcinoma of the colon or rectum who have progressed to at least 2 lines of standard systemic chemotherapy for the metastatic disease, OR participants with pathologically confirmed locally advanced or metastatic sqEC that has progressed after at least a first line of standard systemic therapy for metastatic disease. First-line participants can be enrolled if a platinum doublet is contraindicated or refused by the participants, OR pathologically confirmed locally advanced or metastatic sqNSCLC that has progressed after at least 2 lines of standard systemic therapy for metastatic disease.
No prior chemotherapy for locally advanced or metastatic urothelial cancer\r\n* Perioperative chemotherapy previously administered in the neoadjuvant and/or adjuvant setting is permitted\r\n* Prior chemotherapy administered in the context of chemoradiation as definitive treatment for bladder preservation is also permitted, provided that disease progression outside the prior radiotherapy field is demonstrated histologically or cytologically
Subjects must have previously untreated metastatic colorectal cancer and have no contraindications to treatment with the standard of care regimen as determined by the investigator; prior adjuvant therapy is acceptable (including immunotherapy), but must have been completed at least 6 months prior to metastatic disease diagnosis
PRE-SCREENING: Unresectable locally advanced or metastatic pancreatic cancer, confirmed by histology, and at least one but not more than two prior chemotherapy regimens with progression (neoadjuvant chemotherapy would not be counted as a line of therapy)
FULL STUDY INCLUSION CRITERIA: Unresectable locally advanced or metastatic pancreatic cancer and at least one but not more than two prior chemotherapy regimens with progression (neoadjuvant chemotherapy would not be counted as a line of therapy)
Previous disease progression on or intolerance to one line of therapy – either platinum-based or immunotherapy (pembrolizumab or nivolumab); prior chemotherapy in the induction, organ preservation, definitive or adjuvant setting permitted if it was for initial treatment of locally advanced or metastatic disease and completed more than 4 months prior to enrollment on the current study; 2-week washout period prior to treatment start will be required
Patient who received any prior systemic hormonal therapy for advanced breast cancer; no more than one prior regimen of chemotherapy for the treatment of metastatic disease is permitted Note:
Prior therapy\r\n* Arm A: Rebastinib plus paclitaxel: up to two prior non-taxane chemotherapy regimens for metastatic or incurable locally advanced disease permitted (no prior paclitaxel or eribulin); patients with estrogen receptor (ER)-positive disease are required to have relapse or progression on at least one line of endocrine therapy\r\n* Arm B: Rebastinib plus eribulin: up to three prior chemotherapy regimens for metastatic or incurable locally advanced disease permitted (no prior eribulin, but prior paclitaxel allowed): patients with ER-positive disease are required to have relapse or progression on at least one line of endocrine therapy
At least 1 prior systemic therapy for metastatic disease; adjuvant chemotherapy or concurrent chemoradiation for early stage disease does not count as prior therapy unless patients progressed within 6 months of completion of chemotherapy
At least one prior regimen for treatment of recurrent or metastatic disease\r\n* Note: Prior regimen for recurrent or metastatic disease is not required if the patient had disease progression or recurrence during or within the first 6 months following completion of adjuvant or neoadjuvant chemotherapy
Prior chemotherapy for advanced or metastatic disease
Must have received at least one but no more than 3 lines of chemotherapy for advanced breast cancer\r\n* Patients who have developed metastatic disease on adjuvant hormone therapy within 24 months of completing adjuvant chemotherapy are considered to have had one line of chemotherapy and are eligible for this trial
Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier\r\n* For Part I, prior adjuvant therapy with gemcitabine or a fluoropyrimidine therapy is permitted if completed > 6 months prior to recurrence; no prior PARP inhibitor therapy is allowed\r\n* For Part II, no prior PARP inhibitor therapy is permitted; up to two prior treatment regimens are permitted as follows: 1 adjuvant and 1 metastatic; 1 locally advanced and 1 metastatic; or 2 metastatic, or a variation thereof
ARM C COHORT 4: Patients must not have received prior systemic chemotherapy for advanced or metastatic disease; prior adjuvant chemotherapy or concurrent chemotherapy and radiation are allowed if they were completed >= 6 months prior to the diagnosis of recurrent disease
Have had prior chemotherapy for metastatic disease in castration-resistant prostate cancer (prior chemotherapy for hormone-sensitive disease, more than six months prior to registration, is acceptable)
Patients with prior oral or intravenous chemotherapy for metastatic disease\r\n* Patients may have had adjuvant or neoadjuvant chemotherapy, if therapy was completed more than 6 months prior to enrollment\r\n* Patients whose comorbidities prevent them from being able to receive the designated chemotherapy regimen\r\n* Patients who are assigned to receive epirubicin must have cardiac ejection fraction (EF) of 45% or greater
More than one prior chemotherapy line for metastatic disease
No prior chemotherapy for metastatic disease
Stage II: subjects must have received no more than 1 prior chemotherapy regimen for metastatic disease; and no more than 2 cycles of their current platinum chemotherapy regimen for metastatic disease; they must have recovered to < grade 1 from all toxicities related to the prior chemotherapy; patients who have received perioperative (i.e. adjuvant or neoadjuvant therapy) > 1 year prior to being treated with chemotherapy for metastatic disease will be eligible provided any chemotherapy-related toxicity has recovered to specified levels
Have had no prior systemic chemotherapy for metastatic disease; at least 6 months since prior adjuvant chemotherapy. Additional Inclusion Criteria for Cohort 2:
Patients who have metastatic or recurrent disease after previous surgery, radiation therapy, and/or chemotherapy are eligible. In Stage 1, no restriction is placed on the number of prior therapies. In Stage 2, patients may have 0 or 1 prior chemotherapy treatments for adjuvant or metastatic disease and no prior endocrine therapies.
Cholangiocarcinoma cohort specific criteria:\r\n* Patients must have histologically or cytologically documented carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder with clinical and/or radiologic evidence of unresectable, locally advanced or metastatic disease; patients with ampullary carcinoma are not eligible\r\n* Patients must have failed at least one (but no more than 2) prior line of systemic therapy in the advanced disease setting\r\n* Patients who received adjuvant chemotherapy and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are also eligible; in this case, the adjuvant therapy will count as the minimum required one prior line of therapy; if patient received adjuvant treatment and had disease recurrence after 6 months, patients will only be eligible after failing one regimen of systemic chemotherapy used to treat the (unresectable or metastatic) disease recurrence\r\n* If the patient has had decompression of the biliary tree within the last 14 days, stability of the bilirubin level needs to be confirmed with two measurements that are within 5 to 7 days of each other; (the second measurement must be obtained within 7 days prior to registration); both the first and second measurement must be =< 2.5 x IULN; stability is defined as the second measurement being no more than one point higher than the first
No prior cytotoxic chemotherapy for metastatic disease; prior immunotherapy is permitted
For patients with locally advanced disease, no previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of PDAC is permitted; for patients with metastatic disease, prior treatment for non-metastatic disease with 5-fluorouracil (5-FU) or gemcitabine administered as radiation sensitizer, or as a cytotoxic therapy, in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no >= grade 2 treatment-related toxicities are present
The subject must have progressive disease following at least one prior line of hormonal or chemotherapy for treatment of their metastatic disease
Prior therapy:\r\n* Patients with recurrent, metastatic triple negative breast cancer must have had at least 1 chemotherapy regimen for metastatic breast cancer or have developed metastatic breast cancer within 1 year of completion of adjuvant chemotherapy\r\n* Prior therapy for high grade serous platinum-sensitive ovarian cancer patients must have included 2 prior platinum-based chemotherapy regimens\r\n* Participants must be at least 4 weeks since prior radiation therapy, 3 weeks since prior chemotherapy, and 6 weeks if the last regimen included carmustine (BCNU) or mitomycin C\r\n* No 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\r\n* For any hormonal therapy, participants must have stopped them at least 1 week prior to initiating therapy\r\n* Amount of prior radiotherapy: participants may not have had > 25% of their bone marrow radiated
Patients who have had prior chemotherapy for metastatic pancreatic cancer (other than FOLFIRINOX); prior radiation is allowed; chemotherapy for non-metastatic disease is allowed
Patients may have received any number of prior systemic treatment regimens for distant metastatic disease or advanced regional disease; the following prior therapy is permitted in either the adjuvant or metastatic disease setting:\r\n* No prior therapy\r\n* Immunotherapy consisting of interferon-alpha, interleukin-2, GM-CSF, ipilimumab, anti-PD1, cancer vaccines, or other experimental agent\r\n* Cytotoxic chemotherapy consisting of dacarbazine, temozolomide, carboplatin, or paclitaxel alone or in combination\r\n* Targeted therapy with temsirolimus, bevacizumab, or sorafenib
Any number of prior systemic therapies for metastatic/recurrent disease are permitted in both the phase I and II portions of the study; patients need not have received a prior cetuximab-based chemotherapy regimen to be eligible for this trial
No prior chemotherapy for the treatment of metastatic disease at study entry. Adjuvant chemotherapy is permitted providing cytotoxic chemotherapy was completed 12 months prior to starting the study and without disease recurrence.
Subject must have received at least 1 prior systemic regimen for advanced or metastatic disease
Have received no more than one prior systemic chemotherapy regimen in the relapsed or metastatic setting. Prior treatment with no more than one prior immune checkpoint inhibitor is permitted and will not be considered as a line of systemic chemotherapy.
Have received more than one prior systemic chemotherapy regimen for metastatic disease.
Participants may have received 0-1 prior chemotherapeutic regimens for metastatic breast cancer and must have been off treatment with chemotherapy for at least 14 days prior to registration; no prior platinum in the metastatic setting is allowed; prior platinum in the neo/adjuvant setting is permissible, if at least 12 months elapsed since the end of adjuvant therapy to the development of metastatic disease; all toxicities related to prior chemotherapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 grade 1 or lower; if a patient recurs within 12 months of neoadjuvant or adjuvant chemotherapy, this will be counted as one line of therapy for metastatic disease
Previously received > 1 course of chemotherapy (not including immunotherapies or targeted therapies) for the treatment of metastatic a. Note: Subjects may have received 1 course of chemotherapy prior to surgery for the treatment of locally advanced disease and 1 course of chemotherapy for the treatment of metastatic BC; however, if surgery could not be performed, this will count as the 1 chemotherapy course allowed prior to study
Part A: Subject must have failed at least one prior chemotherapy regimen for metastatic disease and/or is unfit for cisplatin-based chemotherapy.
For Part B - Subjects must not have received any prior systemic treatment for metastatic MCC. Prior chemotherapy treatment in the adjuvant setting (no clinically detectable disease; no metastatic disease) is allowable if the end of treatment occurred at least 6 months prior to study start)
No prior systemic chemotherapy for recurrent or metastatic disease
Patient must have received no prior radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.
Progression on at least one prior systemic chemotherapy for advanced, unresectable or metastatic disease; prior adjuvant or neoadjuvant therapy is not included as prior systemic chemotherapy unless treatment occurred within the 6 months prior to study enrollment\r\n* There is no limit to the number of prior lines of treatment a patient has received\r\n* No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registration\r\n* Patients should have resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, grade 1 or less
Prior chemoradiotherapy for a pelvic recurrence is permitted. Prior chemotherapy in the adjuvant setting for Stage I, II or III disease is permitted. Note: No prior chemotherapy in the setting of Stage IV disease is permitted unless the patient was without evidence of disease at the completion of chemotherapy and had at least six months of progression-free survival since the completion of chemotherapy. Regardless of circumstances, no more than one prior chemotherapy regimen (including chemo-radiotherapy) is permitted.
Patients must have had one or two prior regimens of systemic chemotherapy for metastatic or locally advanced, unresectable disease; (a maintenance regimen of 5-fluorouracil or capecitabine, with or without bevacizumab, should not be counted as a separate line of treatment); prior treatment with irinotecan is allowed; prior treatment for metastatic disease is not required for patients who experienced disease recurrence during or within 6 months of completion of adjuvant chemotherapy
Prior Therapy:\r\n* No more than two regimens in the metastatic setting as long as patients have adequate performance status; patients with no prior chemotherapy for metastatic disease may be included in the trial if they received anthracyclines and taxanes in the adjuvant or neoadjuvant settings; chemotherapy naïve patients with metastatic disease must have failed anthracyclines and taxanes\r\n* Chemotherapy treatment prior to enrollment must be discontinued for at least 3 weeks prior to study entry\r\n* Patients must have completed radiation therapy at least 21 days prior to beginning protocol treatment
Prior therapy with more than one line of cytotoxic chemotherapy following diagnosis of advanced/metastatic disease, or disease which has progressed despite prior fulvestrant therapy.
Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen or >2 endocrine therapies for advanced or metastatic disease
Have had no prior systemic therapy for advanced or metastatic disease. Prior adjuvant therapy should have been completed at least 9 months from documentation of metastatic disease. Prior palliative radiotherapy allowed if toxicities resolved to grade 1 or baseline.
Prior therapy with ? 1 systemic chemotherapy regimen for unresectable or metastatic pancreatic cancer or unwilling/unable to receive systemic chemotherapy
Patients must have been treated with at least one prior systemic treatment for incurable advanced or metastatic SCCA of the anal canal; prior treatment for metastatic disease is not required for patients who develop new metastatic lesions during or within 6 months of completion of chemoradiation for limited-stage disease; patients who receive chemotherapy for incurable advanced or metastatic SCCA of the anal canal must wait a minimum >= 28 days (6 weeks for nitrosoureas or mitomycin C) after the date of completion of chemotherapy prior to initiating treatment with nivolumab on this study; patients who undergo radiotherapy to a site of tumor must wait a minimum >= 3 months from the date of completion of radiotherapy prior to initiating treatment with nivolumab on this study
Have received and failed only 1 prior chemotherapy regimen for metastatic pancreatic cancer\r\n* Must have received and failed only 1 prior regimen administered for pancreatic cancer in the metastatic setting; failure includes development of metastases on or within 3 months of adjuvant chemotherapy treatment or development of metastases on or within 3 months of treatment for locally advanced disease or radiographic disease progression on or within 3 months of treatments for metastatic disease; documented intolerance (grade 3 or 4 toxicity or hospitalization leading to discontinuation) of treatment for metastatic disease will also be considered a failure\r\n* Radiosensitizing doses of chemotherapy are not considered systemic chemotherapy
Patients are allowed to have had a maximum of 1 prior chemotherapy regimen for metastatic disease; patients are allowed to have a maximum of two prior regimens if they previously received neoadjuvant/adjuvant chemotherapy or chemoradiotherapy for their initial localized disease
Prior chemotherapy for metastatic disease
No prior chemotherapy for metastatic disease
Prior systemic chemotherapy for metastatic disease
Up to one prior line of chemotherapy for advanced disease is allowed; if received, prior chemotherapy must be discontinued at least 14 days prior to initiation of protocol therapy
Documented, progressive disease/tumor growth, which may include after exposure to a platinating agent (e.g. cisplatin or carboplatin) or another cytotoxic chemotherapy or radiation in a prior line of therapy, or documented intolerance to such an agent; prior line of therapy may include induction chemotherapy or chemoradiotherapy, in addition to treatment for recurrent/metastatic disease; de novo metastatic disease is also allowed as long as progressive disease/evidence of tumor growth is documented
Patients with metastatic or advanced-stage malignant tumor. Patients may have received up to 2 prior lines of chemotherapy for their metastatic disease
For Cohorts A and B, documented tumor progression (based on radiological imaging) after receiving at least one prior approved platinum-based chemotherapy regimen for advanced stage/metastatic NSCLC. An alternate chemotherapeutic agent/regimen is an acceptable substitute in the event that the subject was intolerant to, or ineligible to receive platinum based chemotherapy. Subjects enrolled in Cohort B cannot have more than 3 prior systemic treatments for advanced stage/metastatic NSCLC (neoadjuvant and adjuvant therapies are not counted in number of prior regimens and maintenance therapy is not counted as a separate regimen). Subjects in Cohort C will be required to have not received prior systemic anti-cancer therapies for metastatic disease (i.e., dabrafenib/trametinib will be 1st line treatment for metastatic disease);
Patients must have had one prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent carcinoma of the cervix\r\n* Chemotherapy administered concurrent with primary radiation (e.g.; weekly cisplatin) is not counted as a systemic chemotherapy regimen for management of advanced, metastatic, or recurrent disease; adjuvant chemotherapy given following the completion of radiation therapy (or concurrent chemotherapy and radiation therapy) is not counted as a systemic chemotherapy regimen for management of advanced, metastatic, or recurrent disease (e.g.; paclitaxel and carboplatin for up to 4 cycles)
Subjects must have recurrent, unresectable, or metastatic cervical cancer and have relapsed after a platinum-containing doublet administered for treatment of advanced (recurrent, unresectable, or metastatic) disease. Subjects must have persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix, with documented disease progression (disease not amenable to curative therapy). Note: The following cervical tumors are not eligible: minimal deviation/adenoma malignum, gastric type adenocarcinoma, clear cell carcinoma and mesonephric carcinoma. Histologic confirmation of the original primary tumor is required via pathology report. Subjects must have had one prior systemic chemotherapeutic regimen for management of persistent, recurrent, or metastatic carcinoma of the cervix (e.g., paclitaxel/cisplatin, paclitaxel/cisplatin/bevacizumab). Chemotherapy administered concurrently with primary radiation (e.g., weekly cisplatin) is not counted as a systemic chemotherapy regimen. Adjuvant chemotherapy given following completion of radiation therapy (or concurrent chemotherapy and radiation therapy) is not counted as a systemic chemotherapy regimen (e.g., paclitaxel and carboplatin for ?4 cycles). Note: Subjects who have received >1 prior regimen are not eligible.
Patients who have received more than one chemotherapy regimen for metastatic disease
Prior palliative chemotherapy for metastatic or recurrent disease
At least 1 prior antineoplastic chemotherapy treatment regimen for metastatic disease and at least 1 prior treatment with a trastuzumab-containing regimen for at least 6 weeks, for metastatic disease or subject relapsing under adjuvant treatment (part 2 only).
More than 2 prior antineoplastic treatment regimens (excluding hormonotherapy) for metastatic disease. Subjects who relapsed under adjuvant treatment shouldn't have received more than one line of chemotherapy for metastatic disease (part 2 only).
No prior systemic chemotherapy for patients who present with metastatic disease. For patients with recurrent head and neck squamous cell carcinoma, prior chemotherapy is allowed if it was given as part of their definitive therapy. If patients have received prior combined modality therapy, they must be off therapy for at least 6 months.
Patient must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
Received more than 1 prior regimen for advanced or metastatic disease.
No prior therapy for metastatic disease except \r\n* For Group A: > 6 months since completion of adjuvant chemotherapy\r\n* For Group B: those patients who enroll just after completing bevacizumab plus either FOLFOX or FOLFIRI
Subjects with histologically confirmed stage IV or recurrent NSCLC (per the 7th International Association for the Study of Lung Cancer classification squamous or nonsquamous histology, with no prior systemic anticancer therapy (including EGFR and ALK inhibitors) given as primary therapy for advanced or metastatic disease\r\n* Prior adjuvant or neoadjuvant chemotherapy is permitted as long as the last administration is at least 2 months prior to enrollment\r\n* Prior definitive chemoradiation for locally advanced disease is also permitted as long as the last administration of chemotherapy or radiotherapy (whichever was given last) occurred at least 2 months prior to enrollment
No prior systemic chemotherapy or WEE1 kinase inhibitor therapy for metastatic or recurrent disease will be allowed; patients are permitted to have received prior systemic chemotherapy as a part of the initial multimodality treatment for locally advanced disease if this treatment was completed more than 6 months prior to enrollment
Received more than 1 prior regimen for advanced or metastatic disease.
Patient treated with more than one prior chemotherapy regimen for recurrent/metastatic disease
For urothelial cancer patients, no prior combination systemic chemotherapy for metastatic disease, except:\r\n* Single-agent radiosensitizing chemotherapy is not considered prior systemic therapy\r\n* Prior neoadjuvant or adjuvant systemic chemotherapy (including cisplatin-based) is allowed provided it was completed >= 6 months prior to the diagnosis of metastatic disease\r\n* Prior intravesical therapy is permitted
For non-urothelial cancer patients, no more than 1 prior line of combination systemic chemotherapy for metastatic disease is allowed
A single regimen of prior chemotherapy for metastatic melanoma is allowed; patients also may have received other immunotherapy or biologic therapy (including kinase inhibitors, antibodies to checkpoints CTLA4, PD1, PDL1, etc.) for metastatic melanoma and there is a limit of three therapy regimens
For participants who present with de novo metastatic disease, no prior systemic chemotherapy is allowed
Received no prior chemotherapy for advanced or metastatic disease (Part 2 and Part 2a)
May have received ?1 prior systemic chemotherapy regimen for metastatic disease.
Patients may not have received more than two prior systemic treatment regimens for distant metastatic disease; the following prior therapy is permitted in either the adjuvant or metastatic disease setting:\r\n* No prior therapy\r\n* Immunotherapy consisting of interferon, interleukin-2, filgrastim (GM-CSF), ipilimumab, anti-programmed death (PD)1 or other experimental agent\r\n* Cytotoxic chemotherapy consisting of dacarbazine, temozolomide, carboplatin +/- paclitaxel
Prior systemic therapy (including chemotherapy, biological or hormonal therapy) will be permitted for palliative treatment of metastatic or unresectable relapsed disease; additionally, previous chemotherapy delivered with curative-intent (i.e., chemoradiotherapy or adjuvant [postoperative] chemotherapy at a time disease was considered potentially curable) will be permitted; prior taxane (including paclitaxel or docetaxel) and/or platinum exposure will be permitted; however, patients must not have experienced disease progression within 3 months of platinum-based therapy; at least 4 weeks must have elapsed since prior chemotherapy or radiation therapy, 6 weeks if the last regimen included carmustine (BCNU) or mitomycin C; toxicities from prior anticancer therapy must have recovered to =< grade 1
Patient may not have previously received chemotherapy for metastatic disease, except adjuvant therapy completed at least 6 months before the first evidence of metastasis
Patients with metastatic disease who are eligible for first line FOLFOX chemotherapy. Adjuvant or neoadjuvant given at least 12 months prior for non-metastatic disease is permitted.
Phase II: Patient who recurs with metastatic disease =< 6 months of completing adjuvant chemotherapy after curative-intent surgical resection is not eligible; patients who recur with metastatic disease > 6 months after completion of adjuvant chemotherapy are eligible
No prior chemotherapy for metastatic disease
Participants are allowed to have received up to 2 prior lines of chemotherapy in the metastatic setting; if a prior chemotherapy was given for less than 1 cycle, it will not be counted as a prior line; the last dose of chemotherapy must be =< 14 days prior to initiation of study therapy; participants should be adequately recovered from acute toxicities of prior treatment; no prior treatment with eribulin mesylate is allowed
Prior treatment with >1 chemotherapy regimen for metastatic disease
Prior chemotherapy for metastatic breast cancer (MBC) (prior adjuvant chemotherapy permitted as long as > 12 months [mo])
Have had prior chemotherapy for metastatic disease in castration-resistant prostate cancer (prior chemotherapy for hormone-sensitive disease, more than twelve months prior to registration, is acceptable)
Patient must NOT have a history of > 1 line of administered chemotherapy for metastatic disease and must be off chemotherapy for a minimum of 2 weeks; prior chemotherapy in the adjuvant setting is allowed
Patients initially diagnosed with locally advanced pancreatic cancer who have undergone chemotherapy then resection and were with no evidence of disease are eligible if metastatic relapse of disease has occurred and if the last dose of chemotherapy was more than 4 months before the data of study entry.
Criteria 3, Participants had disease progression during or after one or more prior standard of care systemic anti-cancer therapy (eg chemotherapy, targeted therapy) for metastatic disease
One, 2, or 3 prior lines of chemotherapy for metastatic disease and with progression of disease on last treatment regimen.
Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive by an FDA-approved assay performed centrally. Patients must be ALK positive by local test prior to submitting tissue to the central lab. Randomization will occur after ALK positive confirmation is received from the central lab. Patients may have received up to 1 prior chemotherapy regimen for metastatic disease, which may also include maintenance therapy. Note that patients that have received adjuvant or neoadjuvant chemotherapy and developed metastatic disease within 6 months from the end of that therapy would be considered to have received 1 prior regimen for metastatic disease.