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)
Progression of disease after 1 or 2 prior regimens in the metastatic setting
More than one prior chemotherapy regimen administered in the metastatic setting.
Patients must meet at least one of the following criteria:\r\n* Disease progression any time after non-steroidal aromatase inhibitor (AI) use in the advanced disease setting\r\n* Relapse while on or within =< 12 months of end of adjuvant non-steroidal AI therapy with or without prior endocrine therapy for advanced disease\r\n* NOTE: In either setting, treatment with any prior endocrine therapy must be completed >= 2 weeks prior to course 1 day 1 (C1D1) of study treatment with the exception of exemestane which is permitted in the advanced disease setting within =< 4 weeks immediately prior to C1D1; prior adjuvant exemestane is allowed if the disease free interval is > 12 months from the discontinuation of exemestane; prior faslodex, everolimus, palbociclib or other cyclin-dependent kinase (CDK) inhibitor (e.g. ribociclib, abemaciclib) use are allowed and must have been completed >= 2 weeks prior to C1D1; failure to adhere to this washout guideline will result in a protocol violation
Patients may have had prior systemic therapy in the adjuvant setting; however this adjuvant treatment must not have included a CTLA4 or PD1 pathway blocking antibody or a BRAF/MEK inhibitor; also, patients may not have had any prior systemic treatment for advanced (measurable metastatic) disease
EFTs: no more than two prior chemotherapy-containing lines in the metastatic/recurrent setting.
Patients must have received irinotecan therapy in the metastatic setting; there are no limitation on number of prior therapies in the metastatic setting
Prior therapy is allowed as follows:\r\n* Platinum chemotherapy in the adjuvant setting is allowed, if the last platinum dose was > 12 months before identification of metastatic disease; platinum-based chemotherapy in the metastatic setting is not permitted\r\n* History of prior anthracycline (e.g. doxorubicin, epirubicin) and taxane-based (e.g. paclitaxel, docetaxel) chemotherapy in the neo-adjuvant / adjuvant or metastatic setting is preferred, but not required\r\n* Patients with hormone receptor-positive (estrogen and/or progesterone receptor-positive) disease must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy; endocrine therapy must have been completed at least 7 days before study treatment\r\n* Prior radiation is allowed; radiation therapy must have been completed at least 21 days before study treatment\r\n* Prior treatment with Food and Drug Administration (FDA) approved or investigational biologics (other than PARP inhibitors) and novel molecularly targeted therapies, including oral or IV formulations, shall not exclude patients from participation\r\n* For agents with ambiguous categorization, final determination of patient eligibility will be made by the protocol chair prior to enrollment\r\n* Prior PARP inhibitor use is not allowed for this study
Received =< four (4) prior chemotherapy regimens in the metastatic setting
Any number of prior lines of therapy are allowed\r\n* Prior platinum based therapy is allowed in the following settings:\r\n** Treatment in the neoadjuvant and/or adjuvant setting without clear progression of disease\r\n** Treatment in the metastatic setting without clear progression of disease
Prior treatment specifics:\r\n* Participants must have radiological or objective evidence of progression to a CDK4/6 inhibitor regimen in the metastatic setting AND relapse/progression on an nonsteroidal anti-inflammatory drug (NSAI) (defined as either relapsed =< 12 months after completing adjuvant NSAI or progressed through an NSAI for metastatic or locally advanced breast cancer)\r\n* Participants may have received any number of previous endocrine/hormonal lines of therapy in the metastatic setting, as long none of them were exemestane-based and the last dose is >= 14 days prior to registration\r\n* Participants may have received any CDK4/6 inhibitor (i.e. palbociclib, ribociclib, abemacicliclib, etc) as long as the last dose is >= 14 days prior to registration\r\n* Participants may have received up to one prior chemotherapy line for advanced breast cancer as long as the last dose is >= 21 days prior to registration\r\n* Participants may have received prior biologic treatments or investigational drugs as long as the last dose is >= 21 days prior to registration\r\n* Participants may have received radiotherapy for palliative purposes but must not be experiencing > grade 1 treatment related toxicities and have completed treatment >= 14 days prior to registration
Participants who have received prior treatment with exemestane in the metastatic setting or who have recurred within 12 months of adjuvant exemestane
SAFETY RUN-IN: Patients received up to 2 prior regimens for their disease in the metastatic setting
Patients with only non-measurable bone lesions must have disease progression based on PCWG3 with 2 or more new lesions or have prostate-specific antigen (PSA) progression before enrollment. Arm 4: Patients with extensive-stage disease small cell lung cancer (SCLC) must meet the following criterion: i. Patients received ? 2 prior lines of therapy. Arm 5: Patients with HER2-negative gastric or gastroesophageal junction cancer must meet the following criterion: i. Patients received ? 2 prior lines of therapy. Arm 6: Patients with locally advanced or metastatic urothelial (muscle-invasive bladder, ureter, urethra or renal pelvis) cancer must meet the following criterion: i. Patients received ? 2 prior lines of therapy in the advanced or metastatic disease setting. ii. Patients must have received prior platinum-based systemic chemotherapy. Arm 7: Patients with advanced or metastatic pancreatic adenocarcinoma must meet the following criteria: i. Patients must have received at least one line of platinum containing regimens in either an advanced or metastatic setting, unless the patient has known deleterious germline or somatic BRCA1/2 mutation prior to being screened (in which case they can be considered for the study if the patient has never received platinum-containing regimen), AND ii. Patients received ? 1 prior lines of therapy in the advanced or metastatic disease setting. Arm 8: Patients with advanced or metastatic solid tumor malignancies must meet the following criterion: i. Patients with at least 1 prior platinum-containing treatment in any treatment setting.
Cohort A:\r\n* Prior treatment with at least one regimen containing trastuzumab and taxane\r\n* No prior treatment with T-DM1 that was discontinued due to disease progression or toxicity\r\n* No more than 4 prior lines of therapy in the metastatic setting
No prior therapies (except for anti-estrogen therapy) are allowed for the treatment of the newly diagnosed metastatic breast cancer; patients are allowed to have had prior chemotherapy for breast cancer in the adjuvant setting for at least 12 months prior to enrollment into this study; patients with a prior diagnosis of malignancy treated >= 5 years ago are eligible, provided that they have not received prior nab-paclitaxel as part of their prior treatment regimen, and that they meet all eligibility criteria
Patients with NSCLC must have predominant squamous histology. Patients must have received prior therapy with a platinum-based treatment and a checkpoint inhibitor (CPI), if eligible, and should have received no more than 2 systemic regimens in the locally advanced or metastatic setting.
Patients with SCCHN must have received prior therapy with a platinum-based regimen and a checkpoint inhibitor (CPI), if eligible, and should have received no more than 2 systemic regimens in the recurrent/metastatic setting.
Have received no more than 2 prior lines of therapy (maintenance therapy given in the metastatic setting will not be considered a separate regimen). Generally, treatments that are separated by an event of progression are considered different regimens.
Prior therapy for breast cancer in the advanced/metastatic setting must have included at least:
One prior systemic therapy in the metastatic setting is allowed, but patients who have not had any prior systemic therapies in the metastatic setting are also eligible\r\n* Note: patients who were started on endocrine therapy monotherapy as their 1st line or 2nd line systemic therapy in the metastatic setting for no more than 28 days and without clinical progression prior to the initiation of the study drug therapy are allowed to enroll on the study as their 1st line or 2nd line therapy, respectively
No prior systemic therapy in the metastatic or advanced setting
Prior cetuximab is allowed in the adjuvant but not in the metastatic setting, but must have been completed at least 6 months before starting this trial
Prior exposure to panitumumab in any setting
No more than 3 lines of chemotherapy in the metastatic setting.
Arm A: MBC with progression and no prior endocrine based systemic therapy in the metastatic setting;
Arm C: MBC with progression during or following one or two prior endocrine based systemic therapies in the metastatic setting, and following prior therapy with a CDK inhibitor.
Have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting, or in case of having received (neo)adjuvant pertuzumab, at least 1 prior line of anti-HER2 directed therapy in the metastatic setting. In either case, patients must have received prior treatment with pertuzumab, in the (neo)adjuvant or metastatic setting. Prior radiotherapy, hormonal therapies, and other anti-HER2 therapies are allowed.
Prior treatment with at least one, and no more than three, lines of therapy overall in the metastatic setting. Patients must have progressed on or following, the most recent line of therapy.
Must have received 4 or more prior lines or therapy in the metastatic setting
Treatment with chemotherapy within 28 days of registration including subjects who received more than 2 chemotherapy regimens in the metastatic setting at any time prior to registration
Patients must have had two or more lines of prior therapy (chemo or hormonal) in the metastatic setting
Patients must have had at least one line of therapy in the metastatic setting
Patients must have had at least one prior line of therapy for breast cancer in the metastatic setting
Histologically or cytologically confirmed metastatic or unresectable CRC that is relapsed, refractory, or progressive following at least 2 prior systemic regimens in the metastatic setting.
Both patients with stage IV and patients with recurrent disease after progression must have had at least 1 line of standard systemic therapy in the advanced/metastatic setting; a. patients with HER2-positive disease must have had at least 2 lines of anti-HER2 therapy, including Perjeta and Kadcyla in the metastatic setting; b. prior eribulin treatment is allowed
Received one or more prior therapies for TNBC or inflammatory breast cancer in the metastatic setting, and prior treatment (metastatic or (neo) adjuvant) must have included a prior taxane and/or anthracycline-based therapy.
More than 3 previous lines of therapy in the metastatic setting.
Prior chemotherapy, hormonal and radiation therapy administered in the adjuvant setting will be allowed
Any number of prior systemic treatment regimen in the advanced/metastatic setting is allowed (cytokine, anti-angiogenic, mTOR inhibitor or clinical trial) including previously untreated patients
Prior therapies:\r\n* Patients must have previously received an aromatase inhibitor in the adjuvant, neo-adjuvant or metastatic setting\r\n* The minimum duration of aromatase inhibitor (AI) in the adjuvant setting is 2 years\r\n* There is no minimum duration of AI in the metastatic setting or neoadjuvant setting\r\n* Patients may have been previously treated with a CDK 4/6 inhibitor or mTOR inhibitor or other investigational agent in addition to an aromatase inhibitor\r\n* Prior treatment with tamoxifen is allowed in the adjuvant setting provided that it was followed by a minimum of 2 years of an AI
Prior therapy exclusions:\r\n* Prior therapy with fulvestrant\r\n* Prior therapy with tamoxifen in the metastatic setting\r\n* More than 3 prior lines of endocrine therapy in the metastatic setting\r\n* More than one prior line of chemotherapy in the metastatic setting
Patients must be in consideration for 1st line systemic therapy for recurrent IBC; NOTE: Patients must not have received chemotherapy in the metastatic setting, but adjuvant treatment after surgery is acceptable
Prior treatment\r\n* No more than two prior chemotherapy regimens in the metastatic setting\r\n* Prior treatment with fulvestrant in the metastatic setting is required, except for patients with a history of ER-negative metastatic breast cancer\r\n* Unlimited prior endocrine therapy regimens in the metastatic setting are allowed\r\n* No prior treatment with an aurora Kinase inhibitor (either an aurora A or pan-aurora kinase inhibitor)
Have previously received prior treatment with at least 1 but no more than 3 chemotherapy regimens in the metastatic setting.
Patients must satisfy the following criteria for prior therapy:\r\n* Progressed on and following at least 6 months of combined treatment with palbociclib and AI therapy for advanced/metastatic breast cancer, and be able and willing to receive additional palbociclib treatment; palbociclib and AI must be the most recently received treatment prior to enrollment; up to one (1) prior line of chemotherapy for advanced/metastatic disease is allowed in addition to any number of prior lines of endocrine therapy\r\n* No prior treatment with fulvestrant, everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway in the metastatic setting; use of these agents in the neoadjuvant and/or adjuvant settings is permitted\r\n* Patients receiving bisphosphonate therapy prior to registration may continue at the same intervals used prior to study registration
Prior chemotherapy in the adjuvant setting is allowed
Patients must have had =< 3 prior therapies in the metastatic setting (not including chemotherapy given as maintenance therapy)
Metastatic colorectal cancer patients \r\n* Patient must have received a minimum of 1 systemic therapy in the metastatic setting
Prior trastuzumab use in the adjuvant or metastatic setting
> 2 lines of prior chemotherapy in the metastatic setting
Any number of prior lines of chemotherapy in the metastatic setting is allowed
Patients must have received at least one, but not more than three, systemic regimens for treatment of metastatic soft tissue sarcoma; patients must have had a prior anthracycline in either the adjuvant or metastatic setting unless medically inappropriate for the patient
Patients must have had at least 2 lines of anti-HER2 directed therapies either in the metastatic or early-stage disease setting
Phase I only: Histologic confirmation of pancreatic, colorectal, gastroesophageal or biliary adenocarcinoma, as follows:\r\n* Patients with metastatic disease from pancreatic cancer who received no more than 2 lines of prior therapy in the metastatic setting\r\n* Patients with metastatic disease from colorectal cancer who received no more than 3 lines of prior therapy in the metastatic setting\r\n* Patients with metastatic disease from gastroesophageal cancer who received no more than 1 line of prior therapy in the metastatic setting\r\n* Patients with metastatic disease from biliary tract cancer who received no more than 1 line of prior therapy in the metastatic setting\r\n* NOTE: No prior exposure to irinotecan in the metastatic setting will be allowed except in the phase I dose escalation portion and in colon cancer patients only; in pancreas cancer, exposure to irinotecan is only allowed in the neoadjuvant setting and no progressive disease < 3 months from last dose of irinotecan
Phase Ib only: Histologic confirmation of pancreatic or gastroesophageal adenocarcinoma, as follows:\r\n* Patients with metastatic disease from pancreatic cancer who received no more than 1 line of prior therapy in the metastatic setting\r\n* Patients with metastatic disease from gastroesophageal cancer who received no more than 1 line of prior therapy in the metastatic setting\r\n* NOTE: No prior exposure to any irinotecan in the metastatic setting will be allowed
Received no more than one prior regimen of chemotherapy in the metastatic setting
No prior systemic chemotherapy treatment in the metastatic setting
Patients may not have had a prior anti-angiogenic agent in the recurrent setting; prior use of bevacizumab in the upfront or upfront maintenance setting is allowed
Patients must have received at least one prior line of chemotherapy, for ULMS (either in the adjuvant or metastatic setting)
At least one prior systematic therapy in the metastatic setting
PRE-MENOPAUSAL ELIGIBILITY: \r\n* Premenopausal women who received adjuvant aromatase inhibitor and ovarian suppression (AI + OS) in the adjuvant setting and completed at least 12 months of hormonal therapy\r\n* Pre-menopausal women with de novo metastatic disease are eligible if they have had no prior endocrine therapy\r\n* Premenopausal women who have not received tamoxifen in the metastatic setting, but have received up to two lines of chemotherapy
POSTMENOPAUSAL ELIGIBILITY: \r\n* Postmenopausal women who have progressed on first-line or second line therapy with an aromatase inhibitor in the metastatic setting\r\n* Postmenopausal women who have recurred while on or after completion of adjuvant treatment with aromatase inhibitors (they have completed at least one year of AI in the adjuvant setting before progression on AI)\r\n* Postmenopausal women who are not considered candidates for treatment with an aromatase inhibitory by their oncologist, patients not willing to go on AI, or patients who were intolerant to AI\r\n* Postmenopausal women are allowed (but not required) to have up to two lines of prior chemotherapy regimens in the metastatic setting for the dose expansion phase; for the dose escalation cohort, up to three previous lines of chemotherapy in the metastatic setting is acceptable
Patient has received tamoxifen in the metastatic setting (for more than 30 days) or has progressed while on tamoxifen in the adjuvant setting
Patients must have received at least 1 chemotherapy regimens in the setting of metastatic disease
All patients should have received at least one line of chemotherapy in either the advanced or adjuvant setting and hormonal therapy (where appropriate)
At least one prior regimen of chemotherapy in the setting of metastatic breast cancer; no upper limit on the number of prior endocrine regimens for metastatic breast cancer, however no more than 6 chemotherapeutic regimens may have been given in the metastatic setting
Treatment naïve (ie, no prior chemotherapy in the metastatic disease setting and no prior ALK inhibitor therapy allowed).
Disease progression after crizotinib only. No prior chemotherapy is allowed in the metastatic disease setting.
Disease progression after crizotinib and 1 or 2 prior regimens of chemotherapy in the metastatic disease setting.
Treatment naïve (ie, no prior chemotherapy in the metastatic disease setting and no prior ROS inhibitor therapy).
Subjects may have had any number of prior chemotherapy, endocrine therapy, immunologic, or biologic regimens for metastatic breast cancer; treatment with prior platinum compounds (except cisplatin) is allowed as long as it has been 6 months or more since exposure to prior platinum; prior cisplatin treatment is allowed IF it was given in the adjuvant setting
Women must have received ? 1 prior hormonal treatment(s) in the metastatic or adjuvant setting. If the most recent hormonal treatment was in the metastatic setting, duration of response (tumor regression or stabilization of disease) to this specific course of therapy must be ? 6 months. If the most recent hormonal treatment was in the adjuvant setting, duration of response (disease free) to this specific course of therapy must be ? 3 years
Part B: Subject must not have received any prior lines of chemotherapy in the metastatic setting (prior treatment with immunotherapy is allowed).
No more than 2 prior chemotherapies in the advanced or metastatic setting
Prior treatment\r\n* No more than two prior chemotherapy regimens in the metastatic setting\r\n* Prior treatment with an aromatase inhibitor (either anastrozole, letrozole or exemestane), either in the adjuvant or metastatic setting is required\r\n* Unlimited prior endocrine regimens in the metastatic setting, which may have included an everolimus or cyclin dependent kinase (CDK) 4/6 inhibitor (such as palbociclib, abemaciclib or ribociclib) containing regimen\r\n* Prior tamoxifen treatment is allowed in the adjuvant setting, but patients must not have experienced relapse within 1 year of stopping tamoxifen\r\n* No prior treatment with tamoxifen in the metastatic setting\r\n* No prior treatment with endoxifen\r\n* Patients who have not fully recovered from acute, reversible effects of prior therapy regardless of interval since last treatment are not eligible to participate in this study\r\n** EXCEPTION: neuropathies-if grade 2 neuropathies have been stable for at least 3 months since completion of prior treatment patient is eligible
Subjects must have received at least one line of hormonal therapy in the metastatic setting
Patients enrolling onto Arm C (FOLFIRI) or Arm D (MM-398 with 5-FU and leucovorin) must have failed one prior line of gemcitabine-based therapy with or without BBI608 in the metastatic setting. No additional lines of therapy in the metastatic setting are allowed. Prior adjuvant therapy with gemcitabine is allowed as long as disease recurrence occurred > 6 months of last dose of therapy. Toxicities related to prior therapy must have completely resolved (except for alopecia and anemia), or be deemed irreversible. Prior treatment with radiotherapy is allowed.
Randomized Phase 2 Dose Expansion - Individuals may have disease progression during treatment or within 12 months of completion of endocrine therapy (tamoxifen, and/or AI) in the adjuvant setting, or disease progression during treatment with endocrine therapy (tamoxifen, AI or CDK4/6 inhibitor plus AI) for advanced/metastatic disease. Individuals may have had unlimited prior hormonal therapy, but must be naive to fulvestrant in the metastatic setting. A total of 2 prior chemotherapies are allowed, however, only one for metastatic disease is permitted.
For Cohort 2: had prior systemic therapy in the advanced disease setting
Previous treatment with any systemic antineoplastic therapy in the advanced setting (NSCLC stage IIIB or IV. Patients who received only one cycle of antineoplastic therapy in the advanced setting are allowed).
Received more than 3 prior systemic treatment regimens with chemotherapy , hormonal, or immunotherapy in the metastatic setting or received more than 1 prior chemotherapeutic regimen in the metastatic setting
Prior treatment with standard first line therapy in the metastatic setting
The patient must have received at least 1 and no more than 2 prior lines of treatment in the metastatic setting.
Have received prior treatment with at least 2 chemotherapy regimens, of which at least 1 but no more than 2 have been administered in the metastatic setting.
Subject has received > 1 prior line of chemotherapy in the metastatic setting
Patients may have received but may not have progressed on prior anti-angiogenic therapy in the upfront setting
Prior therapies:\r\n* All women: at least one prior line of hormonal therapy for de novo disease (stage IV metastatic at diagnosis, no prior adjuvant therapy) or relapse > 1 year after completion of adjuvant therapy; relapse on adjuvant hormonal therapy will count as the one prior line of therapy\r\n* All women: at least 1 prior line of chemotherapy in the adjuvant and/or metastatic setting, but not more than 2 regimens in the metastatic setting
Unlimited number of lines of endocrine therapy and one line of cytotoxic chemotherapy in the metastatic setting (Phase II)
Patients may have received 1-3 prior systemic therapies in the metastatic setting.
Participants must have had prior trastuzumab therapy (either in the adjuvant or metastatic setting)
Must have had treatment with at least 2 but no more than 3 previous regimens in the metastatic setting. Previous treatment must have included an anthracycline and taxane in either the adjuvant or metastatic setting.
Patients should not have been previously treated with cytotoxic drugs and immunotherapeutic agents for unresectable stage III or stage IV disease; prior ipilimumab in metastatic setting is not allowed; prior therapy may include one line of targeted therapy for metastatic disease i.e. v-raf murine sarcoma viral oncogene homolog B (BRAF) or mitogen-activated protein kinase kinase (MEK) inhibitor; at least 3 weeks should have passed since the last dose of prior adjuvant interferon therapy and prior targeted therapies, and all previous therapy related toxicities should have resolved before starting study treatment; prior adjuvant interferon is permitted; prior cytotoxic therapy in adjuvant or metastatic setting is not allowed; prior ipilimumab in adjuvant setting is not allowed; prior adjuvant therapy with targeted therapy including but not limited to B-RAF, MEK inhibitors etc. is allowed; prior palliative radiation therapy for metastatic melanoma is permitted provided the patient has unirradiated metastatic sites for response evaluation and has fully recovered from its toxicity
Any number of prior endocrine therapies in the metastatic setting are allowed. The patient must not have received any prior chemotherapy agents in the metastatic setting. Prior treatment with adjuvant docetaxel or paclitaxel is allowed if disease relapse occurred greater than 12 months from the completion of adjuvant therapy.
Patients with ER and/or PR- positive/ HER2 non-amplified invasive mammary carcinoma must have had at least one line of endocrine therapy in the metastatic setting, or be diagnosed with metastatic breast cancer during or within 1 year of adjuvant endocrine therapy; there is no limit on lines of prior treatment in the metastatic setting
Patients with ER and/or PR-positive/ HER2-amplified invasive mammary carcinoma must have had at least one line of HER2-targeted therapy in the metastatic setting, or be diagnosed with metastatic breast cancer during or within 1 year of adjuvant HER2-targeted therapy; there is no limit on lines of prior HER2-targeted treatments in the metastatic setting
Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting
No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting, and evidence of progression on or after last treatment regimen received and within 6 months of enrollment
Prior systemic anti-cancer treatment in the advanced or metastatic setting; prior systemic treatment in the adjuvant setting is allowed
Any number of previous chemotherapy regimens (except those containing TMZ or dacarbazine [DTIC]) in the metastatic setting are allowed as long as >= 4 weeks have elapsed from last treatment
Prior taxane therapy in the adjuvant or metastatic setting is allowed
Patients who have received other agents that modulate or downregulate the estrogen receptor (e.g. raloxifene, fulvestrant) in the adjuvant setting are eligible if they were on treatment for at least 6 months prior to disease progression in the locally advanced or metastatic setting
Prior endocrine therapy in the metastatic setting may include any aromatase inhibitor (AI) or tamoxifen, but may not include prior fulvestrant; in the metastatic setting, 1-2 prior lines of endocrine therapy are allowed
Prior treatments:\r\n* Subjects should have received at least two approved HER2-targeted agents (trastuzumab, pertuzumab, or TDM-1) in the course of their disease\r\n* Subjects should have had at least 1 line of prior HER2-targeted therapy in the metastatic setting, with the exception of asymptomatic subjects with oligometastatic or bone/soft tissue only disease who, on investigator opinion, are appropriate for a single agent antiendocrine therapy per National Comprehensive Cancer Network (NCCN) guidelines\r\n*Subjects who have had up to 2 lines of prior endocrine therapy in the metastatic setting are allowed; prior adjuvant and/or neoadjuvant endocrine regimens are allowed and not counted towards this limit
PRIOR THERAPY PHASE I and PHASE I-T:\r\n* Prior chemotherapy for ovarian cancer patients must have included a first-line platinum-based regimen with or without intravenous consolidation chemotherapy\r\n* Breast cancer patients must have recurred post both an Adriamycin- and taxane-containing regimen\r\n* Prior hormonal-based therapy for ovarian, primary peritoneal serous, fallopian tube cancer, or breast cancer is acceptable\r\n* Patients may not have had a prior PAR polymerase (PARP)-inhibitor in the recurrent or metastatic setting; prior treatment with BSI-201 (iniparib) is allowed\r\n* Patients may not have had a prior anti-angiogenic agent in the recurrent or metastatic setting
Received more than 2 prior regimens for advanced or metastatic disease (not including hormonal therapy in the metastatic setting or neoadjuvant or adjuvant therapies)
Patients must have received at least two lines of systemic therapy for breast cancer in the metastatic setting; patients who are hormone receptor positive must have received at least one line of hormonal therapy AND one line of chemotherapy in the metastatic setting
Patients may not have received more than 2 prior systemic treatment regimens for distant metastatic disease. The following prior therapy is permitted in either the adjuvant or metastatic disease setting, provided treatment is discontinued at least 4 weeks prior to initiating study treatment:
No more than two prior chemotherapy regimens administered for the treatment of pancreatic cancer in the adjuvant or advanced/metastatic setting
Have received prior chemotherapy in the metastatic castration-resistant setting (prior chemotherapy in the hormone-sensitive setting is allowed provided last dose was at least 6 months prior to study entry)
Prior taxanes in the neoadjuvant or adjuvant setting with progression occurring within 6 months of completion of taxane therapy; or any taxanes in the metastatic setting.
More than one prior chemotherapy regimen administered in the metastatic setting.
Documented radiographic disease progression following at least one line of therapy in the advanced/metastatic setting
Patients may have had up to 1 prior line of therapy (cytotoxic therapy only) in the recurrent setting; bevacizumab in the upfront setting is allowed, however bevacizumab or other vascular endothelial growth factor (VEGF) pathway targeted therapy in the recurrent setting is not allowed; hormonal therapy does not count as a prior line
Patients may not have received more than 1 prior line of endocrine therapy in the metastatic setting
Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
Part I: Postmenopausal women with locally ABC or MBC whose disease relapsed during treatment with (or within 6 months after discontinuation of) an AI in the adjuvant setting or progressed during treatment with an AI in the metastatic setting.
For participants in the second NSCLC cohort expansion, not more than two prior regimens in the metastatic setting
At least one line of endocrine therapy in the metastatic setting
Must have a biopsy in the metastatic setting with HER2 expression of 1+ or 2+ by IHC
The participant has received more than 2 prior regimens of systemic therapy in the metastatic setting
Participants must have already received or been intolerant to at least two lines of hormonal therapies (including the adjuvant or metastatic setting) or be appropriate candidates for chemotherapy
Patients must have at least 1 standard treatment regimen in the advanced, recurrent or metastatic setting
Have received prior chemotherapy in the metastatic castration-resistant setting (prior chemotherapy in the hormone-sensitive setting is allowed provided last dose was at least 6 months prior to study entry)
Part 3, Dose exploration, CRC subjects can be treatment naïve but should not have received more than one line of systemic therapy in the recurrent/metastatic setting.
Prior treatment of pancreatic cancer in the metastatic setting (or locally advanced setting) with surgery (placement of stent is allowed), radiotherapy, chemotherapy or investigational therapy
At least one prior line of chemotherapy in the metastatic setting
Subjects must have received at least one line of hormonal therapy in the metastatic setting.
Subjects who are eligible as per the Investigator's assessment and according to the local label for treatment with exemestane and everolimus as a second line or greater of hormone therapy in a metastatic setting.
Phase Ib dose escalation only: Any number of prior lines of endocrine therapy is allowed with the exception of cytotoxic therapy which is limited to one prior line administered in the advanced (metastatic or locally advanced) setting.
Patients with adenocarcinoma arising from the esophagus, gastroesophageal junction, or stomach must also meet the following criteria: a. Must have received prior treatment with a platinum/fluoropyrimidine-based therapy with or without an anthracycline in the metastatic setting; or, in the adjuvant setting if recurrence occurred within 6 months of completing systemic adjuvant treatment; b. Patients with HER2 positive tumors must have had prior treatment with a Her2 inhibitor (e.g. trastuzumab or lapatinib); c. Patients who have received prior taxane therapy may be enrolled.
No prior treatment with carboplatin in the metastatic setting; carboplatin in neoadjuvant/adjuvant setting may be allowed if prior treatment with carboplatin was completed at least one year prior to initiation of this study and after discussion with the study chair
For adjuvant setting patients: Metastatic Disease (M+) prior to surgery
For salvage setting patients: Metastatic Disease at PSA rise
For adjuvant setting patients, any treatment received after surgery
History cancer with no limitation on prior lines of therapy in the metastatic setting
No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting
Part C: must have previously received prior treatment with at least 1 but no more than 2 chemotherapy regimens in the metastatic setting
More than two prior lines (may be combination regimens) of chemotherapy for angiosarcoma (neoadjuvant/adjuvant treatment does not count as a line of treatment)
Completed at least 6 cycles of neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the combination of both; prior platinum as potentially curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant treatment for breast cancer is allowed; (for neoadjuvant patients all chemotherapy should be delivered prior to surgery; no further cycles of chemotherapy post-surgery are allowed)
First-line patients who have disease progression within 12 months of neoadjuvant or adjuvant treatment with chemotherapy.
RANDOMIZED PHASE II CLINICAL TRIAL: Patients may have received adjuvant or neoadjuvant chemotherapy with or without carboplatin or gemcitabine before randomization with an interval not less than 12 months since completion of adjuvant/neoadjuvant treatment
For Parts A, B, C, D, E, G and I: Have received prior systemic chemotherapy for metastatic disease. However, the participant may have received prior systemic chemotherapy in the neoadjuvant or adjuvant setting.
ADJUVANT COHORT: Patients who already started on adjuvant hormonal therapy are eligible under the following conditions:\r\n* For the 26 patients who enrolled in the initial cohorts and derived benefit from neoadjuvant PD 0332991 (C1D1 Ki67 > 2.7% and C1D15 Ki67 =< 2.7%), adjuvant PD 0332991 should be initiated as soon as possible if adjuvant hormonal therapy has been initiated and the patient has completed radiation if indicated\r\n* For patients who enrolled in the endocrine resistant cohort and derived benefit from neoadjuvant PD 0332991 (C1D15 Ki67 =< 10%), adjuvant PD 0332991 should be initiated within 6 months or sooner after initiation of adjuvant hormonal therapy.
Histologically confirmed stage IV NSCLC, with no prior systemic anti-cancer therapy of any kind (including EGFR and ALK inhibitors), prior definitive chemoradiation for locally advanced disease is permitted as long as the last administration of chemotherapy or radiation (whichever was given last) occurred at least 6 months prior to enrollment; prior adjuvant or neoadjuvant chemotherapy for early stage lung cancer is permitted if completed at least 6 months prior to initiating study treatment
Unresolved toxicity from all radiation, adjuvant/ neoadjuvant chemotherapy, other targeted treatment including investigational treatment
No limit on prior lines of therapy for metastatic disease; prior adjuvant or neoadjuvant chemotherapy does not count as a prior line of therapy as long as completion of the adjuvant or neoadjuvant therapy was more than 1 year prior to patient enrollment
Prior chemotherapy for prostate cancer except if administered in neoadjuvant or adjuvant setting
Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative setting in patients with localized disease
Platinum-resistant or -sensitive after completing first-line treatment (debulking surgery and adjuvant or neoadjuvant treatment with standard of care treatment such as carboplatin and paclitaxel). Subjects may have had any number of subsequent lines of chemotherapy.
Must have received prior platinum containing chemotherapy for advanced/metastatic non-small cell lung cancer, or have refused or be ineligible for such therapy; prior neoadjuvant/adjuvant platinum containing chemotherapy will count has having received prior platinum, provided that disease recurred within 6 months of completion of neoadjuvant/adjuvant therapy
Patient may have had prior neoadjuvant and/or adjuvant therapy (chemotherapy, vaccines or experimental agents) within 4 weeks prior to randomization, if the PSA rise and PSADT were documented after the testosterone level was > 150 ng/dL
Have received prior platinum therapy in the past 3 months (Part 1) or 6 months in the adjuvant or neoadjuvant setting (Part 2).
PART I: Adults with HER2+ bladder cancer in the adjuvant setting (adjuvant bladder cancer patients):\r\n* Tumor stage T3a, T3b, T4a, T4b and any node positive disease regardless of tumor stage\r\n* Tumors that are HER2 1+, 2+ or 3+ by IHC or have a Vysis FISH result >= 1.8\r\n* Status-post primary cystectomy with curative intent\r\n* May or may not have received neoadjuvant cisplatin-based combination chemotherapy per National Comprehensive Cancer Network (NCCN) guidelines\r\n* May or may not have received adjuvant radiotherapy or chemotherapy based on pathologic risk per NCCN guidelines\r\n* Greater than or equal to 6 weeks s/p primary surgery with curative intent
No prior chemotherapy for inoperable locally advanced or mUC. For patients who received prior adjuvant/neoadjuvant chemotherapy or chemo-radiation for urothelial carcinoma, a treatment-free interval > 12 months between the last treatment administration and the date of recurrence is required in order to be considered treatment naive in the metastatic setting
Patients who have received a total of at least 36 weeks of trastuzumab therapy (including neoadjuvant and adjuvant settings)
There is no restriction on the use of fluoropyrimidine-containing regimen in the neoadjuvant or adjuvant setting
Neoadjuvant chemotherapy or adjuvant chemotherapy delivered before radiation
Subjects who have documented disease recurrence within 6 months of completing neoadjuvant or adjuvant chemotherapy for limited disease will be eligible for study; subjects who recur greater than 6 months after completing adjuvant chemotherapy will not be eligible unless they receive additional chemotherapy for advanced disease
Prior neoadjuvant or adjuvant systemic therapy or local intravesical chemotherapy or immunotherapy is permitted if such therapy was completed at least 12 months prior to the initiation of study treatment and if all toxicities from such therapy have improved to grade 1 or stabilized or resolved
Has received prior chemotherapy for NSCLC with the exception of neoadjuvant or adjuvant platinum-based chemotherapy for NSCLC completed > 6 months prior to enrollment
Patients who had prior carboplatin in the metastatic setting are not eligible\r\n* Note: Prior carboplatin as neoadjuvant or adjuvant treatment is permitted
Subjects must have progression of disease within 12 months of platinum-containing chemotherapy (chemotherapy could have been given in the neoadjuvant, adjuvant or metastatic settings) for urothelial cancer
Disease recurrence less than 6 months from the last dose of prior neoadjuvant or adjuvant therapy (including VEGF-R TKI)
Patients who received adjuvant or neoadjuvant platinum-doublet chemotherapy (after surgery and/or radiation therapy) and developed recurrent or metastatic disease within 6 months of completing therapy are not excluded.
Patients should be chemotherapy naive in the stage IV non-small cell lung cancer (NSCLC) setting, with the exception of chemotherapy for neoadjuvant or adjuvant treatment that completed at least 6 months before the study treatment
Patients may have received adjuvant or neoadjuvant chemotherapy with or without trastuzumab and pertuzumab with an interval greater than 12 months since completion of adjuvant/neoadjuvant treatment
Completion of neoadjuvant or adjuvant chemotherapy
Prior adjuvant or neoadjuvant therapy for localized or locally advanced RCC is allowed provided recurrence occurred = or > 6 months after the last dose of the adjuvant or neoadjuvant therapy
Must have received at least 1 prior systemic therapy for advanced disease (does not include adjuvant/neoadjuvant therapy in a curative setting)
Patients who received adjuvant or neoadjuvant chemotherapy (after surgery and/or radiation therapy) and developed recurrent or metastatic disease within 6 months of completing therapy are eligible and the adjuvant or neoadjuvant chemotherapy will count as a line of therapy as above
INCLUSION CRITERIA FOR TNBC: Patients must have received standard adjuvant, neoadjuvant, and/or metastatic chemotherapy per National Comprehensive Cancer Network (NCCN) or institutional practice; no maximum on number of prior systemic treatment regimens
Randomized phase II: be treatment naive in the stage IV setting; subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease < 6 months of completing therapy are ineligible for this arm; subjects with recurrent disease >= 6 months after completing a platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a systemic regimen given to treat the recurrence, are eligible for this arm
At least one prior line of systemic therapy for the sarcoma diagnosis (neoadjuvant, adjuvant or metastatic disease)
Any neoadjuvant or adjuvant chemotherapy regimen is permitted; prior chemotherapy for the treatment of this breast cancer is not required
Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment.
Patients who have had surgery or radiotherapy with or without neoadjuvant or adjuvant chemotherapy (the wash-out period will be at least 1 month)
No prior first line systemic treatment (prior adjuvant or neoadjuvant treatment is permitted); subjects whose disease has progressed after 6 months of last systemic chemotherapy or chemo-radiation in the adjuvant or neoadjuvant setting are eligible
Have been a participant in Hopkins Institutional Review Board (IRB) protocol (J0810) application number 00-01-58-58 entitled \A randomized three-arm neoadjuvant and adjuvant feasibility and toxicity study of a GM-CSF secreting allogeneic pancreatic cancer vaccine administered either alone or in combination with either a single intravenous dose or daily metronomic oral doses of cyclophosphamide for the treatment of patients with surgically resected adenocarcinoma of the pancreas\ (the J0810 cohort), or IRB protocol (J1568) application number 00-05-05-17 entitled “A Randomized Study of a GM-CSF secreting allogeneic pancreatic cancer vaccine with or without a PD-1 Blockade Antibody (Nivolumab) for the Neoadjuvant and Adjuvant Treatment of Patients with Surgically Resectable Adenocarcinoma of the Pancreas” (the 1568 cohort) or have never received any type of pancreatic cancer vaccine/immunotherapy, had the Whipple surgery within 18 months and completed the planned adjuvant chemotherapy and/or chemoradiation (the vaccine-naive cohort)
Stage I of the trial: newly diagnosed disease for which neoadjuvant or adjuvant chemotherapy is planned in the curative setting, or metastatic disease
Treatment by imatinib as neoadjuvant/adjuvant therapy within 4 weeks prior baseline
Subjects whose adjuvant or neoadjuvant treatment for early stage breast cancer was completed within 6 months prior to entry into the study.
No prior systemic therapy for RCC with the following exception: i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
Completed last cycle of chemotherapy (which can be given in the adjuvant and/or neoadjuvant setting) >= 60 days but not >= 365 days prior to randomization
Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy
Relapsed after or refractory to one or two prior lines of chemotherapy for advanced or metastatic/recurrent disease (at least one cycle each) which have not included a PD-L1 or FGFR inhibitor; at least one regimen should have included a platinum agent unless contraindicated for the subject; prior neoadjuvant or adjuvant chemotherapy (without a PD-L1 or FGFR inhibitor) is permitted and will not be counted as first-line chemotherapy, as long as the subject has not progressed within 12 months of the last dose; however, a regimen of neoadjuvant or adjuvant chemotherapy will be counted as first-line chemotherapy if the patient progressed within 12 months of the last dose
Prior therapy:\r\n* At least 1 prior chemotherapy regimen for treatment of metastatic breast cancer, and/or\r\n* Recurrence within 12 months of completion of neoadjuvant/adjuvant chemotherapy, and/or\r\n* For patients with inflammatory breast cancer but no distant metastases, progression through standard (anthracycline- and taxane-based) neoadjuvant chemotherapy is required
Must have received trastuzumab (neoadjuvant, adjuvant or metastatic setting)
No prior neoadjuvant/adjuvant therapy for DCIS diagnosis
The participant has disease progression during or within 4 months after last dose of first-line chemotherapy or during or within 6 months after the last dose of neoadjuvant or adjuvant therapy.
Prior exposure to taxane in the adjuvant, neoadjuvant or metastatic setting
Patient has completed multi-agent adjuvant or neoadjuvant chemotherapy of ? 4 cycles or ? 12 weeks which included taxanes prior to screening
Previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer. Participant may have received prior neoadjuvant or adjuvant therapy as long as it was completed at least 6 months prior to randomization
Regimens received in the adjuvant/neoadjuvant setting or for locally advanced breast cancer within the past 6 months will also be considered toward the maximum of 2 prior lines of therapy. Adjuvant/neoadjuvant chemotherapy for one cancer event will count as one prior line of therapy, if received within the past 6 months.
Prior systemic therapy for this type of sarcoma; neoadjuvant or adjuvant therapy more than two years prior would not apply
Prior neoadjuvant, adjuvant, or palliative chemotherapy for ATC is allowed.
Metastatic disease with documented disease progression following previous treatment with at least one, but no more than 2 prior therapies, with one of the prior therapies having been either gemcitabine-based or fluoropyrimidine-based therapy. Neoadjuvant and/or adjuvant therapies for localized resectable or unresectable PDAC each count as a line of therapy if multiagent chemotherapy regimens were administered (and neoadjuvant regimen was different than adjuvant regimen) and if the participant progressed with metastatic disease while taking or within 6 months of completion of (neo)adjuvant therapy.
Prior ADT given for < 39 months in duration and > 9 months before randomization as neoadjuvant/adjuvant therapy.
Patients must have had prior treatment with anthracyclines and/or taxanes (resistant) or platinum including adjuvant or neoadjuvant therapy
Individuals who have received only neoadjuvant or adjuvant therapy for gastric adenocarcinoma
Prior chemotherapy for advanced BC. Previous adjuvant/neoadjuvant chemotherapy is allowed (carboplatin, cisplatin or gemcitabine only if > 12 months has passed since last administration).
Patient has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant or any CDK4/6 inhibitor.
Prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment
Received at least one prior pemetrexed-based chemotherapy for unresectable disease, unless within 3 months of receiving platinum-pemetrexed therapy for neoadjuvant or adjuvant treatment that has been unsuccessful
No prior use of anthracyclines and taxanes for metastatic disease or in the adjuvant or neoadjuvant setting
Has received systemic therapy for the treatment of their stage IV NSCLC. Completion of 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 disease.
Prior therapy with interferon alfa (in neoadjuvant, adjuvant, or metastatic settings) (Part 1A only)
Subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within 6 months of completing therapy are eligible
Prior therapy should have included a taxane and/or anthracycline (unless contraindication to those) in the neoadjuvant, adjuvant, or advanced/metastatic setting. a. Hormone receptor positive patients must also have hormone resistant disease (progression during at least one prior hormonal therapy) for which chemotherapy is indicated.
Must have completed preoperative (neoadjuvant) chemotherapy. NOTE: Acceptable preoperative regimens include an anthracycline or a taxane, or both. Patients may NOT have received cisplatin as part of their neoadjuvant therapy regimen. Patients who received preoperative therapy as part of a clinical trial may enroll. No adjuvant chemotherapy after surgery other than that specified in this protocol is allowed. Adjuvant bisphosphonate use is allowed.
Prior chemotherapy or immunotherapy for metastatic urothelial bladder cancer; prior neoadjuvant or adjuvant chemotherapy with first progression > 12 months is allowed
Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months
Any prior systemic or investigational therapy for metastatic pancreatic cancer; systemic therapy administered alone or in combination with radiation in the adjuvant or neoadjuvant setting is permissible as long as it was completed > 6 months prior to the time of study registration
Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment
The participant has documented disease progression during or within 4 months after the last dose of first-line chemotherapy for metastatic disease, or during or within 6 months after the last dose of neoadjuvant or adjuvant therapy.
No prior systemic chemotherapy for metastatic disease (adjuvant or neoadjuvant platinum-based chemotherapy with recurrence >12 months since completion of therapy is allowed)
Prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting
Prior adjuvant or neoadjuvant therapy if disease progression or relapse has occurred during or within 12 months after the last dose of treatment
Participants who received prior adjuvant/neoadjuvant chemotherapy and progressed within 12 months of treatment with a platinum-containing adjuvant/neoadjuvant regimen were considered as second-line participants.
Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, everolimus, or any CDK4/6 inhibitor
Subject has received prior cytotoxic chemotherapy (including definitive chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.
Progression after neoadjuvant or adjuvant platinum based chemotherapy if the recurrence occurred while on neoadjuvant/adjuvant chemotherapy or within 6 months since the last administration of such therapy.
Patients may have received prior neoadjuvant and/or adjuvant hormonal therapy, for non-metastatic disease but it must not have lasted for more than 36 months; at least 12 months must have elapsed since completion of androgen deprivation therapy in the neoadjuvant and/or adjuvant setting
Patients with a history of prior neoadjuvant/adjuvant hormone therapy are eligible provided they have received twenty four or less months of hormone treatment (single or combination treatment, excluding orchiectomy); neoadjuvant/adjuvant hormone therapy must have been discontinued at least 6 months prior to registration; this is intended to exclude patients who might have been rendered indirectly androgen insensitive
Prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting at least 12 months from last dose to study entry elapsed.
Must have completed preoperative (neoadjuvant) chemotherapy. NOTE: Acceptable preoperative regimens include an anthracycline or a taxane, or both. Participants who received preoperative therapy as part of a clinical trial may enroll. Participants may not have received adjuvant chemotherapy after surgery prior to randomization. Bisphosphonate use is allowed.
Prior chemotherapy for prostate cancer except if administered in the adjuvant/neoadjuvant setting
Active second cancer other than specified; active cancer refers to cancer that requires systemic chemotherapy or biological therapy within 6 months of the study entry; patients who have received only hormonal therapy in the neoadjuvant or adjuvant setting in the past 6 months may participate in this study
PRE-REGISTRATION INCLUSION CRITERIA: Planning to receive best practice adjuvant or neoadjuvant chemotherapy according to institutional guidelines; adjuvant tamoxifen or aromatase inhibitors treatment will be allowed for hormone receptor-positive patients; patients who have failed neoadjuvant endocrine therapy will also be eligible
Evidence of disease progression documented within 6 months after completion of prior neoadjuvant or adjuvant cytotoxic chemotherapy, or both, or radiotherapy for GEJ adenocarcinoma
Prior therapy for NSCLC that may include surgery, radiation therapy, immunotherapy and/or ? 2 prior chemotherapy regimens (such as neoadjuvant/adjuvant treatment), however only 1 chemotherapy regimen in the metastatic setting is allowed.
Patients receiving preoperative (Neoadjuvant) and postoperative adjuvant chemotherapy (within 12 weeks of surgery) with the same agent(s) will be considered to have received a single chemotherapy regimen.
Patients may have received prior neoadjuvant or adjuvant endocrine therapy. In the case of neoadjuvant or adjuvant NSAI (letrozole/anastrozole) therapy patients must have completed therapy at least 1 year prior to study enrollment.
No prior systemic treatment for advanced or metastatic colorectal cancer is allowed; prior regional chemotherapy (e.g., hepatic arterial infusion) is also not allowed; patients may have received previous neoadjuvant or adjuvant chemotherapy and/or chemoradiation per institutional standard of care; the last course of adjuvant therapy must have been concluded > 12 months prior to colorectal cancer recurrence
Previous treatment with anti-HER2 agents for breast cancer, except trastuzumab and/or lapatinib in the neoadjuvant or adjuvant setting
One prior adjuvant or neoadjuvant therapy for localized or locally advanced RCC is allowed provided recurrence occurred ? 6 months after the last dose of the adjuvant or neoadjuvant therapy
Prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed
Patients who have progressed/recurred following neoadjuvant/adjuvant chemotherapy for earlier stage disease, if completed within the previous 6 months, are eligible.
Prior neoadjuvant/adjuvant hormonal or chemotherapy is allowed if it was last used > 12 months prior to enrollment
Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting
Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy
Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
For subjects receiving adjuvant therapy only, subjects must not have received prior neoadjuvant treatment. Endocrine treatment for less than 30 days prior to surgery is not considered prior neoadjuvant treatment
Prior treatment with taxanes if given as full-dose chemotherapy for advanced disease; as neoadjuvant therapy, taxanes cannot be used in 6 months prior to enrollment
Received only 1 prior systemic chemotherapy regimen for Stage IIIb, IV, or recurrent disease not including neoadjuvant and/or adjuvant therapy. (NOTE: Exceptions may be allowed based on prior treatment regimens and tumor types in agreement with protocol requirements.)
Received up to 2 prior chemotherapy regimens (not including neoadjuvant/adjuvant therapy) for advanced or metastatic disease
Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy for pancreatic adenocarcinoma
A subject with non-metastatic castration-resistant prostate cancer (CRPC) may not have received prior chemotherapy unless in the neoadjuvant or adjuvant setting > 24 months ago and may not have received prior zoledronic acid or denosumab
Patients who have received more than two prior lines of antineoplastic therapy for advanced disease. Chemotherapy administered as neoadjuvant or adjuvant treatment more than six months prior to study enrollment is not considered a prior line of therapy for purposes of this study.
Patient's naïve to first-line therapy for the advanced stage of the disease. Previous neoadjuvant or adjuvant therapy is allowed for patients who successfully underwent complete radical surgery and if last treatment was administered more than 12 months prior to the start of the study treatment, i.e., D1 of Cycle 1.
Patients may have had any number of prior surgeries, radiation and/or chemotherapy regimens as adjuvant, neoadjuvant or palliative therapy for the treatment of their disease
Prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization
Adjuvant or neoadjuvant therapy for AGC is allowed.
At least 12 months since prior neoadjuvant or adjuvant chemotherapy
The last course of adjuvant or neoadjuvant chemotherapy must have ended > 12 months prior to colorectal cancer recurrence
Relapsed or refractory (lack of response) to ?1 course of systemic therapy regimen(s), excluding adjuvant or neoadjuvant chemotherapy, and is incurable by either surgery or radiation.
Disease recurrence within one year after neoadjuvant or adjuvant platinum-based systemic chemotherapy, measured from the date of last dose of chemotherapy or surgery until the day the informed consent is signed
Previous chemotherapy for locally advanced or metastatic gastric carcinoma (adjuvant or neoadjuvant chemotherapy must be completed at least 6 months prior to randomization)
Has received systemic therapy for the treatment of advanced stage NSCLC. Completion of 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 disease
Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrent disease of less than 6 months
If prior adjuvant or neoadjuvant chemotherapy, the last dose of adjuvant or neoadjuvant treatment was administered at least 6 months prior to randomization.
Patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months.
Relapse or failure of one first line chemotherapy (in the case of recurrent disease one additional prior regimen is allowed for adjuvant, neoadjuvant or neoadjuvant plus adjuvant therapy).
Prior taxanes (except for adjuvant or neoadjuvant therapy more than 6 months prior to treatment day 1) (phase II)
Scheduled to begin an appropriate adjuvant or neoadjuvant chemotherapy regimen as defined by National Comprehensive Cancer Network (NCCN) guidelines
Subjects do not need to have measurable or evaluable disease; chemotherapy may be administered in the neoadjuvant, adjuvant, or metastatic setting
Cohort 1: First-line soft tissue sarcoma of intermediate or high grade. Adjuvant or neoadjuvant chemotherapy allowed if no tumor recurrence for at least 12 months since the last measurement, beginning or end of last chemotherapy.
Post neoadjuvant or adjuvant chemotherapy, if prescribed
Prior chemotherapy in the neoadjuvant or adjuvant setting
Participants will have completed surgery (lumpectomy or mastectomy) with or without neoadjuvant or adjuvant chemotherapy and with or without radiation
Scheduled to receive chemotherapy in the neoadjuvant or adjuvant setting
Patients with histologically confirmed breast cancer scheduled to receive chemotherapy with doxorubicin and cyclophosphamide (adjuvant or neoadjuvant)
Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent
SCREENING PHASE: Plan to receive adjuvant or neoadjuvant chemotherapy that includes weekly paclitaxel
INTERVENTION PHASE: Receiving adjuvant or neoadjuvant chemotherapy that includes a taxane
Stage I-III female breast cancer patients who have undergone chemotherapy (either neoadjuvant or adjuvant) 6 - 60 months prior to recruitment
Received any prior adjuvant or neoadjuvant therapy for NSCLC.
Neoadjuvant or adjuvant therapy of any kind
Patient may have had any number of prior chemotherapy regimens in the adjuvant/neoadjuvant and/or metastatic setting (including none)
Patient may have had any number of prior treatments with anti-HER2 strategies in the adjuvant/neoadjuvant and/or metastatic setting (including none)
Patient may have had any number of prior hormonal therapies in the adjuvant/neoadjuvant and/or metastatic setting (including none)
Prior therapy (at least one completed dose) with a taxane-containing regimen in the neoadjuvant or adjuvant setting
Prior therapy with an anthracycline-containing regimen in the neoadjuvant, adjuvant, or metastatic setting, where indicated by local regulation or Investigator judgment.
Subjects who have received prior adjuvant therapy for pancreatic adenocarcinoma are eligible if neoadjuvant and adjuvant therapy (including chemotherapy and/or radiotherapy) was fully completed more than 4 months before the start of study treatment. In this case, prior Gem and/or NP is allowable
Gastric Carcinoma (including Gastro-Esophageal Junction Adenocarcinoma): progression following at least one prior line of standard therapy that contained a fluoropyrimidine and/or platinum and/or taxane agent; prior adjuvant or neoadjuvant therapy is counted as one regimen, provided that disease progression occurs within 6 months after the completion of adjuvant or neoadjuvant therapy; HER2 negative subjects (defined by HER2 ? 2+ by IHC) by medical history; archival tissue or fresh tumor biopsy
For the purposes of this study, neoadjuvant and/or adjuvant chemotherapy regimens do not count as a prior line of therapy.
For participants who received prior adjuvant/neoadjuvant chemotherapy or chemo-radiation for urothelial carcinoma, a treatment-free interval more than (>) 12 months between the last treatment administration and the date of recurrence is required in order to be considered treatment naive in the metastatic setting