Prior treatment with =< two prior cytotoxic regimens; prior therapy must have consisted of at least one of the following: cisplatin, carboplatin, paclitaxel, docetaxel or gemcitabine; if the only prior cytotoxic therapy was administered in the perioperative i.e. neoadjuvant or adjuvant settings, patient is eligible provided the interval from end of therapy to the diagnosis of metastatic disease is less than one year
Part D) Triple-negative disease and received 1 prior non-hormonally-directed or cytotoxic therapy in the MBC setting; or
Prior cytotoxic chemotherapy for metastatic prostate cancer; prior treatment with genomically-targeted agents, or Provenge is allowed
Previous treatment with cytotoxic chemotherapy therapy in the recurrent/metastatic setting; previous treatment with non-cytotoxic agents in the recurrent/metastatic setting is permitted
Patients having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study
Up to 2 prior cytotoxic chemotreatment regimens in the metastatic setting are allowed; adjuvant chemotreatment will not be considered a prior line of treatment
Regarding prior malignancies:\r\n* Patients with a second active malignancy being actively treated at the time of screening with palliative or curative intent with cytotoxic chemotherapy, surgery, or radiation are ineligible\r\n* Patients with stage III or stage IV cancers of any type who have completed cytotoxic chemotherapy, surgery, or radiation in the adjuvant setting within 3 years of screening are ineligible  \r\n** For these patients, if more than three years have passed from the completion of adjuvant therapy to screening for the current protocol, then the patient is eligible for enrollment\r\n* However, patients with stage I or stage II cancers of any type, and who have completed cytotoxic chemotherapy, surgery, or radiation in the adjuvant setting by the time they are screening for the current protocol are eligible for enrollment\r\n* Patients who are being treated with adjuvant hormonal therapies, such as anti-estrogens or anti androgens, are eligible for enrollment provided they stop the hormonal therapy prior to starting the study medications\r\n* Finally, patients with cervical cancer in situ, in situ carcinoma of the bladder, or non-melanoma carcinoma of the skin that have been removed, are eligible for enrollment at any time\r\n* Questions regarding the inclusion of individual subjects should be directed to the principle investigator
Received prior systemic cytotoxic chemotherapy or investigational agent(s), excluding EGFR TKIs, for metastatic NSCLC. [Notes: 1) Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic NSCLC. 2) If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment. 3) Prior exposure to traditional medicine(s) is allowed as long as therapy was discontinued at least 4 weeks prior to the first dose of study treatment.]
Have received treatment with at least one or more lines of cytotoxic chemotherapy in the metastatic setting.
Prior therapy: Eligible subjects must have had 1 line of systemic cytotoxic treatment; this may be adjuvant therapy with documented progression within 12 months of completion, or 1 line of cytotoxic therapy for metastatic disease; NOTE: eligible patients are allowed up to 2 lines of systemic cytotoxic treatment, of which only 1 line is allowed for metastatic disease; the acceptance of progression within 12 months of adjuvant is part inclusion to not require patient to re-challenge with chemotherapy (chemo) if they progressed soon after adjuvant therapy; prior hormonal therapy for metastatic/recurrent disease is also allowed; prior targeted therapy not directed against cMET or vascular endothelial growth factor (VEGF) pathways is allowed
Prior treatment with cytotoxic chemotherapy is not a requirement, but allowed only if used in neoadjuvant, adjuvant or for bladder preserving protocols, as long as was administered > 6 months prior to starting study
Prior treatment with any cytotoxic chemotherapy in metastatic setting; prior treatment with cytotoxic chemotherapy is allowed only if used in neoadjuvant, adjuvant or for bladder preserving protocols, as long as was administered > 6 months prior to starting study
No more than one prior systemic therapeutic regimen for unresectable stage III or stage IV melanoma; this includes chemotherapy, biologic therapy, biochemotherapy, or investigational treatment; this does not include any therapies given in the adjuvant setting; however, patients are excluded if they have a history of prior treatment for melanoma (either adjuvant or metastatic disease) with ipilimumab or other cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor, or prior interferon-alpha treatment for metastatic disease (history of adjuvant interferon-alpha is allowed); there should be a 4-week washout period between last treatment administration and initiation of study therapy
Patients must not have received any prior cytotoxic chemotherapy for metastatic prostate cancer; prior cytotoxic chemotherapy with curative intent in the neoadjuvant or adjuvant setting is allowed; at least 2 years must have elapsed since completion of cytotoxic chemotherapy in the neoadjuvant and/or adjuvant setting
Prior conventional cytotoxic chemotherapy for metastatic or recurrent disease; prior adjuvant, neoadjuvant or chemoradiotherapy for NSCLC is permitted, provided at least 6 months elapsed prior to documented metastatic recurrence
More than two prior lines of cytotoxic chemotherapy (e.g., gemcitabine, doxorubicin, capecitabine) for metastatic disease.
First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy unless the Investigator determines that one of the 4 cytotoxic chemotherapy agents in the control arm would otherwise be offered to the subject
Patients with advanced or metastatic breast cancer must have TNBC. Patients with advanced or metastatic disease may have received up to 2 lines of cytotoxic therapy. Adjuvant and/or neoadjuvant therapies are not counted in the number of lines of therapy. TNBC patients who have previously received platinum chemotherapy in the metastatic setting are allowed to enroll in the study as long as they did not progress while on or within 8 weeks from the day of the last platinum administration.
Participant has received prior cytotoxic chemotherapy (including chemotherapy in combination with radiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy accompanied by surgery with curative intent that was completed one year prior to Cycle 1 Day -2.
Previous hormonal therapy for metastatic breast cancer or cytotoxic adjuvant chemotherapy is allowed
Prior cytotoxic chemotherapy for metastatic prostate cancer. Prior cytotoxic chemotherapy with curative intent in the neoadjuvant or adjuvant setting is allowed but must have been completed at least 6 months prior to registration. No cytotoxic chemotherapy is allowed during protocol specified therapy.
Patient has had prior systemic therapy for MCC\r\n* Note: prior systemic cytotoxic chemotherapy will be allowed if it was administered in the adjuvant setting (no clinically detectable MCC at the time) and treatment concluded more than 6 months prior to beginning study treatment
No more than two lines of prior cytotoxic chemotherapy in the recurrent/metastatic (palliative intent) treatment setting
More than two prior lines of cytotoxic chemotherapy in the recurrent/metastatic disease setting (palliative treatment intent)(excluding single agent use of an EGFR inhibitor)
No prior cytotoxic chemotherapy or targeted therapy in the advanced or metastatic setting; post-operative adjuvant therapy for previously resected NSCLC is allowed as long as the last dose was given greater than 1 year before study entry, and there is current evidence of disease progression
More than three prior lines of cytotoxic chemotherapy for metastatic disease
Participants may have 0-1 prior lines of cytotoxic chemotherapy in the metastatic setting
Prior treatment with cytotoxic chemotherapy for advanced NSCLC; neoadjuvant/adjuvant chemotherapy is permitted if at least 6 months has elapsed between the end of chemotherapy and randomization
Neoadjuvant/adjuvant cytotoxic chemotherapy initiated < 12 months prior to study randomization will be counted as one prior treatment
Neoadjuvant/adjuvant cytotoxic chemotherapy initiated ? 12 months prior to study randomization will not be counted as one prior chemotherapy treatment
Not more than 2 prior regimens in the metastatic setting, including one prior cytotoxic regimen and one prior non-cytotoxic regimen (prior treatment with adjuvant therapy within 6 months of recurrence is considered a treatment regimen in the metastatic setting).
Patients may not have received any cytotoxic chemotherapy for treatment in the metastatic setting
EXPANSION COHORT A ONLY: more than one prior cytotoxic chemotherapy regimen in the setting of recurrent and/or metastatic disease (cytotoxic chemotherapy given as part of neoadjuvant therapy, adjuvant therapy, or concurrent chemoradiation for curative intent is not included in this exclusion item); this does not apply to expansion cohort B
For patients in the dose-expansion cohort of the study, not more than two prior lines of cytotoxic chemotherapy in the metastatic setting
Prior systemic anticancer therapy: Patients will have received at least 1 platinum-based chemotherapy regimen, but no more than 2 cytotoxic chemotherapy regimens in the setting of recurrent or metastatic disease; the regimen(s) may have included biological, molecularly targeted or immune therapies; adjuvant chemotherapy is considered 1 cytotoxic chemotherapy regimen if the last administration occurred < 1 year prior to entry
Planned use of cytotoxic chemotherapy during radiation (only adjuvant temozolomide therapy will be used on this protocol)