Recurrent, platinum resistant ovarian cancer (defined as progression within < 6 months from completion of platinum based therapy; the date should be calculated from the last administered dose of platinum therapy)
Part C: Participants with advanced (locally advanced incurable or metastatic) histologically or cytologically confirmed high-grade serous ovarian cancer (high nuclear Grades 2 or 3). Participants should have either platinum-refractory (disease progression during initial platinum therapy) or platinum-resistant (disease progression <6 months after completion of platinum therapy) disease.
Cohort A Dose Escalation (Ribociclib + PDR001): Ovarian participants:\r\n* Metastatic epithelial ovarian cancer, fallopian tube or peritoneal cancer; all histologies (including serous, mucinous, endometrioid, clear cell, malignant mixed Mullerian tumor [MMMT]s and mixed histologies) and tumor grades are eligible\r\n* Prior Chemotherapy: Participants may have received any number of prior lines of chemotherapy for metastatic disease, as long as the last dose is >= 21 days prior to first dose of study treatment\r\n** Must have received a first-line platinum-based therapy and have disease that is platinum-resistant\r\n*** Platinum-resistant disease is defined as disease relapse within 2 to 6 months of prior platinum-based chemotherapy
Ovarian cancer patients must be resistant to platinum therapy (i.e. within 6 months of last platinum therapy)
Patients must have recurrent platinum-resistant disease, defined as progression < 6 months after completion of platinum-based chemotherapy or as persistent disease that remains after completing the most recent line of platinum-based therapy; the platinum-free interval should be calculated from the last administered dose of platinum therapy
Platinum-resistant/refractory disease, defined as progressive disease at the first tumor assessment while receiving platinum-based chemotherapy or within 6 months after treatment (for patients in Part B; disease-specific expansion arms only).
Platinum resistant or refractory ovarian, primary peritoneal or fallopian tube cancer of any subtype; Note: platinum-sensitive disease is allowed in cases where there is a contraindication to platinum-based therapy (i.e., allergy to platinum); this must be reviewed and approved by the principal investigator
Prior treatment with Doxil, topotecan, Gemzar or Taxol chemotherapy for platinum-resistant cancer; Note: Allowed prior therapy with Doxil or Gemzar if given for platinum sensitive disease in combination with a platinum drug AND the Avatar data indicates a drug other than Doxil or Gemzar would be effective; Note: Allowed prior therapies for patients following confirmation of platinum-resistant cancer include:\r\n* Therapeutic antibodies, such as bevacizumab\r\n* Small molecule kinase inhibitors, such as pazopanib\r\n* Vaccines and immunotherapy\r\n* Poly (ADP-ribose) polymerase (PARP) inhibitors\r\n* Endocrine therapies, such as letrozole\r\n* Metronomic oral cytoxan\r\nAll of these exceptions should be confirmed with the principal investigator (PI) prior to registration
Patients who are platinum-sensitive or platinum resistant
Patients must have recurrent or persistent, platinum resistant or refractory epithelial ovarian, fallopian tube or primary peritoneal carcinoma; platinum-resistant disease is defined as a recurrence within 6 months of completing, platinum-based chemotherapy
Cohort 4: Have primary platinum refractory disease.
Epithelial Ovarian Cancer: histologically confirmed diagnosis (by either primary surgical specimen or biopsy for recurrence) of recurrent platinum-resistant/refractory EOC (i.e., disease recurrence within 6 months of completion of or progression during platinum-based chemotherapy). Note that patients with germ cell, sex cord stroma, carcinosarcoma, or sarcoma are eligible only if the tumor has a mixed endometrioid component with a documented Wnt signaling alteration.
Platinum-resistant ovarian cancer is defined as disease that responded to primary platinum therapy and then progressed within 6 months or disease that progressed during or within six months of completing a subsequent platinum therapy.
Primary platinum refractory disease is defined as disease that has not responded to a platinum-based regimen or experienced disease recurrence within 3 months of completing a first-line platinum-based regimen.
Platinum resistance, defined as disease progression within 6 months of completing a platinum-containing chemotherapy regimen. For NSCLC
Part 2,Cohort 3, Must have received only 1 prior platinum-based regimen. Patient must have primary platinum refractory OC (defined as progression either while on initial treatment with the platinum-based therapy or within 1 month following the last dose of treatment)
Patients with primary platinum refractory disease, defined as progression while first line platinum based chemotherapy
Cohort C: Eligible patients must have received no more than 4 lines of systemic cytotoxic chemotherapy and must have disease resistant to platinum therapy (disease that progressed during or within six months of completing subsequent platinum therapy); primary platinum refractory patients are eligible providing they meet other eligibility criteria; in addition to platinum agents, patients must have received and failed, or have been intolerant to taxanes, liposomal doxorubicin or other agents known to confer clinical benefit; patients are not required to fail all these agents if, in the investigator’s opinion, patients would benefit from treatment on current protocol
Resistant/Refractory Small Cell Carcinoma (SCC) patients in 3rd line or beyond that have previously received platinum or patients in 2nd line with platinum-refractory or platinum-resistant disease
Epithelial Ovarian Cancer (EOC), fallopian tube or primary peritoneal cancer and Malignant Mixed Mullerian Tumor (MMMT) of the ovary or uterus. Excludes other non-epithelial ovarian tumors and ovarian tumors with low malignant potential. Patients must have previously received a platinum based regimen for advanced/metastatic disease or have platinum resistant or refractory disease defined as relapse within 6 months. EOC - specific criteria: Patients who progress or have stable disease during first-line treatment or who relapse within 1 month are considered to be 'platinum-refractory'. Patients who respond to primary treatment and relapse within 6 months are considered 'platinum-resistant', and patients who relapse more than 6 months after completion of initial therapy are characterized as 'platinum-sensitive'. Patients who relapse 6-12 months following the end of their initial regimen are classified as 'partially sensitive'. Platinum sensitive patients may be enrolled but must have failed or declined all other lines of FDA approved therapy
Patients must have previously received a platinum based regimen for advanced/metastatic disease and progressed or have platinum resistant or refractory disease defined as relapse within 6 months.
Known severe hypersensitivity to the platinum agent (i.e., carboplatin or cisplatin) or prior partner of platinum agent (i.e., etoposide for SCC and HGNEC; nab-paclitaxel, paclitaxel, or pemetrexed for NSCLC; paclitaxel, pegylated liposomal doxorubicin, docetaxel or gemcitabine for ovarian) planned for the platinum therapy period. If the patient has had prior hypersensitivity reaction to the drug partner of platinum, a patient may enroll as long as it is acceptable to treat with platinum and one of the alternative chemotherapy partner agents.
Patients enrolling in cohort 5, the recurrent platinum-resistant sporadic high grade serous epithelial or high grade endometrioid ovarian cancer group, must have a negative family history of HBOC syndrome, or negative gBRCA1/2m test; patients should have recurrent platinum-resistant - defined as disease recurrence by imaging within 6 months of the last receipt of platinum-based chemotherapy; rising CA125 only is not considered as platinum-resistant disease; patients with primary platinum refractory disease defined as progression during or within 3 months after receiving first-line platinum based chemotherapy are not eligible
Patients enrolling in cohort 6, the recurrent platinum-resistant sporadic high grade serous epithelial or high grade endometrioid ovarian cancer group, must have a negative family history of HBOC syndrome, or negative gBRCA1/2m test; patients should have recurrent platinum-resistant, defined as disease recurrence by imaging within 6 months of the last receipt of platinum-based chemotherapy; this cohort should have measurable (defined by RECIST v1.1) but without biopsiable disease, determined by principle investigator (PI) and interventional radiology (e.g., cystic abnormal mass, not safely biopsiable disease); rising CA125 only is not considered as platinum-resistant disease; patients with primary platinum refractory disease defined as progression during or within 3 months after receiving first-line platinum based chemotherapy are not eligible
Patients must have platinum resistant (platinum-free interval < 6 months) or platinum refractory disease as per Gynecological Cancer Intergroup (GCIC) criteria
Prior use of weekly paclitaxel or bevacizumab in the platinum resistant (disease progression within 6 months of platinum based chemotherapy)/refractory (disease progression during or following the 3 months of the first line platinum based chemotherapy) setting
Subjects with both platinum-sensitive and platinum-refractory disease will be eligible
Primary platinum refractory disease (disease progression on first platinum treatment or recurrence within 3 months of completing first platinum regimen)
Platinum-sensitive disease (exceptions allowed: patient has had a hypersensitivity reaction to platinum or the treating oncologist thinks that further platinum therapy is not in the patient’s best interest)
Ovarian cancer cohort only: Subjects must have platinum refractory or resistant disease.
Patients must be platinum-resistant or platinum-ineligible by fulfilling at least one of the criteria defined below:\r\n* Disease persistence or recurrence within 6 months of completing definitive radiotherapy for locally advanced disease, where platinum chemotherapy was administered as a component of induction and/or concurrent systemic treatment\r\n* Disease progression during, or within 6 months, of treatment with platinum chemotherapy (eg. carboplatin or cisplatin) in the recurrent/metastatic setting\r\n* The patient is not an acceptable candidate for platinum chemotherapy due to medical comorbidities, in the judgment of the local investigator\r\n* Prior platinum exposure may have occurred in any line of therapy (first line, second line, etc.) and is not required to be the most recent therapy received
Patients with platinum sensitive ovarian cancer must have progressed within 6 months of their last platinum-containing regimen, consistent with definition of platinum resistant disease
Patients must be considered platinum resistant according to standard GOG criteria, which defines patients as having had a treatment-free interval following platinum of less than 6 months
Patients must have recurrent, platinum-resistant disease (defined as having relapsed within 6 months of last platinum-containing regimen) or be unable to receive further platinum therapy; there is no limit on the number of prior treatment regimens; however, patients may not have previously received weekly paclitaxel in the recurrent setting; previous dose dense paclitaxel as initial therapy is allowable
Recurrent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer meeting one of the following minimal prior treatment requirement (no limit to the maximum number of prior treatments):\r\n* Platinum resistant: may receive FATE-NK100 as 2nd line (as 1st salvage therapy) with platinum resistant is defined as disease that has responded to initial chemotherapy but demonstrates recurrence within a relatively short period of time (< 6 months) following the completion of treatment\r\n* Platinum sensitive: may receive FATE-NK100 as 3rd line therapy (as 2nd salvage therapy) with platinum sensitive is defined as the recurrence of active disease in a patient who has achieved a documented response to initial platinum-based treatment and has been off therapy for an extended period of time (>= 6 months)
Disease progression following frontline platinum doublet therapy given for metastatic or recurrent disease; there is no restriction on prior lines of therapy following receipt of initial platinum doublet therapy\r\n* Continuation maintenance therapy following platinum-based chemotherapy will not be considered as a separate line of therapy\r\n* Prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation therapy given for locally advanced disease is considered first-line platinum therapy only if recurrent disease developed within 6 months of completing therapy\r\n* Patients with activating EGFR mutations must have received an EGFR tyrosine kinase inhibitor directed therapy prior to platinum therapy\r\n* Patients with ALK translocations must have received an ALK tyrosine kinase inhibitor directed therapy prior to platinum therapy
Platinum-refractory disease, or ineligible/unfit for platinum-based therapy
Platinum-resistant recurrent or metastatic epithelial ovarian carcinoma
Women with platinum-sensitive recurrent ovarian, fallopian or primary peritoneal cancer (defined as recurrent disease > 6 months after completing last platinum-based chemotherapy) eligible to receive platinum-based doublet chemotherapy
Platinum-resistant disease (as defined as progressive disease within 6 months of completion of chemotherapy with a platinum agent)
Platinum resistant or refractory disease as defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of previous platinum treatment.
Patients with recurrent or refractory epithelial ovarian, primary peritoneal or fallopian tube carcinoma, who have received platinum containing chemotherapy and either has platinum refractory or resistant disease, or if platinum sensitive disease, have received >= 2 lines of chemotherapy; subjects may have received PARP inhibitors, bevacizumab, or immunotherapy
Patients must have platinum-sensitive or platinum-resistant recurrent or persistent or refractory ovarian, fallopian tube, or primary peritoneal carcinoma AND have one or more of the following characteristics documented on a validated platform (documented genetic test report is required); historic report is permitted\r\n* A germline BRCA1 or BRCA2 deleterious alteration\r\n* A somatic mutation in BRCA1 or BRCA2 detected in a tumor sample or on circulating tumor deoxyribonucleic acid (DNA)\r\n* Carry a known or likely loss of function alteration in one or more of homologous recombination or mismatch repair pathway genes\r\n* Demonstrate a genomic phenotype of homologous recombination (HR) deficiency as measured by a loss-of-heterozygosity (LOH)-high score\r\n** Recurrent ovarian cancer is defined as recurrence of disease in a patient who achieved initial complete response to primary therapy\r\n** Persistent ovarian cancer is defined as having residual disease in the form of elevated tumor markers or microscopic or clinically evident disease in a patient who has completed and apparently responded to initial chemotherapy\r\n** Refractory ovarian cancer is defined as patients who have failed to achieve at least a partial response to therapy including patients with either stable disease or disease progression during primary therapy\r\n** Platinum-sensitive is defined as achievement of documented response to initial platinum-based treatment and has been off treatment for an extended period of time (more than 6 months)\r\n** Platinum-resistant is defined as relapse within 6 months of last platinum-based chemotherapy or progression while on platinum-based therapy
Participant can be either platinum-sensitive (platinum free interval [PFI] >= 6 months prior to recent recurrence) or platinum-resistant (PFI < 6 months prior to recent recurrence); if the participant has a platinum sensitive disease, she may only enroll in this clinical trial if there is a contraindication for her to receive further treatment with platinum-based chemotherapy (such as serious persistent toxicity or severe hypersensitivity to platinum agents or she declines standard of care)
Patients with ovarian cancer can be platinum-sensitive (with documented progression > 6 months after completion of a platinum containing regimen) or platinum resistant (progression < 6 months after completion of a platinum containing regimen)
Advanced (metastatic or recurrent) pathologically proven urothelial carcinoma which is refractory to platinum based due to disease progression on a platinum containing regimen; patients progressing within 12 months of their last dose of platinum-based neoadjuvant or adjuvant chemotherapy will be considered platinum refractory
Patients whose tumors are deemed to be platinum-refractory will be excluded from the trial
Patients diagnosed with platinum-refractory metastatic urothelial cancer that is measurable based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1; platinum-refractory disease is defined as progressive disease on cisplatin or carboplatin therapy or within 12 months of prior platinum treatment (last dose)
Subjects with both platinum-sensitive and platinum-refractory disease will be eligible
No evidence of progression on a platinum agent (e.g. carboplatin or cisplatin) or within 8 weeks of stopping platinum
Platinum resistant or refractory disease as per standard clinical and Gynecologic Oncology Group definition; patients have had a treatment-free interval of less than 6 months from last platinum-based treatment to recurrence or progression during platinum based therapy
Hypersensitivity to platinum agents
No more than 3 prior lines of cytotoxic chemotherapy for platinum-resistant disease
Histologically confirmed, measurable or non-measurable, recurrent or persistent, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma. By standard Gynecologic Oncology Group (GOG) criteria, platinum-resistant disease is defined by a disease-free interval of less than 6 months following treatment with a platinum-based regimen, or the progression of disease during platinum-based therapy.
Disease progression must be documented following platinum based chemotherapy; this can be in the recurrent or metastatic setting following platinum or in the concurrent setting provided progression has occurred within 6 months from the last dose of platinum
At least one prior line of platinum-based chemotherapy (subjects are eligible for enrollment and leukapheresis while still platinum-sensitive, however, they must have developed platinum resistant disease for treatment (turnstile 2).
Platinum resistant or refractory disease as defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of previous platinum treatment
For the dose expansion cohort, patients with ovarian, fallopian tube or primary peritoneal cancer must have platinum resistant disease defined as progression within 6 months after last platinum regimen; platinum refractory disease is allowed
Subjects who have platinum-resistant disease; there is no limit on the number of prior treatment regimens
Patients must be in their first platinum sensitive recurrence; this is defined as recurrence that occurred greater than six months after completion of first line platinum based therapy; for the phase 1 portion of the study, patients must have a platinum free interval between 6 months and 1 year and are not eligible or unwilling to undergo a second cytoreductive surgery
Patients should have recurrent platinum-resistant or- refractory disease - defined as disease that has progressed by imaging while receiving platinum or had recurrence within 6 months of the last receipt of platinum-based chemotherapy; rising CA125 only is not considered as platinum-resistant or refractory disease
No more than 3 prior treatment regimens (including primary therapy; no more than 1 prior non-platinum based therapy in the platinum-resistant/-refractory setting); hormonal therapies used as single agents (i.e. tamoxifen, aromatase inhibitors) will not count towards this line limit
Ovarian cancer patients must be resistant to platinum therapy; therapy (i.e. within 6 months of last platinum therapy); patients who received greater than two prior platinum containing regimens will not be eligible
For ovarian, fallopian tube, and peritoneal cancers only: platinum-resistant, defined as =< 183 days from the date of the most recent dose of chemotherapy containing either carboplatin or cisplatin until the first evidence of cancer recurrence or progression either symptoms directly attributable to cancer, radiographic recurrence of cancer, or cancer antigen 125 (CA-125) > 70, confirmed >= 7 days later (confirmation of elevated CA-125 may be beyond 183 days and still count as platinum-resistant)
Patients refractory to primary platinum therapy where \refactory\ is defined as\n             disease progression within 6 months of first dose of initial platinum-based therapy.
Patients whose ovarian cancer recurs/progresses within 0-6 months following platinum-based chemotherapy have platinum resistant disease; these patients are not considered to benefit from additional platinum-based therapy and are treated with other sequential single agents; such patients are eligible for this trial
Patients with documented disease recurrence/progression within 6-12 months of completing platinum-based therapy, are considered to have 'borderline' platinum sensitivity; these patients will not be eligible for this trial
Patients who relapse more than 12 months after completion of platinum-based treatment are considered 'platinum sensitive' and will not be eligible for this trial, since they have a favorable (33-59%) chance of responding to further rounds of platinum based chemotherapy
High grade serous ovarian cancer patients with either platinum refractory, platinum-resistant disease or platinum-sensitive disease are eligible; platinum refractory is defined as either relapse less than 2 months after the last platinum based therapy or relapse during platinum therapy; platinum-resistance is defined as relapse within 2 to 6 months after last dose of platinum-based chemotherapy; platinum sensitivity is defined as a relapse greater than 6 months after last dose of platinum-based chemotherapy; participants with platinum-sensitive disease must have progressed after receiving 2 prior platinum-based chemotherapy regimens
Adult patients with documented deleterious BRCA 1 or 2 mutations with histologically confirmed ovarian, primary peritoneal, breast, prostate, pancreas, gastric or other solid tumor whose disease has progressed following at least one standard therapy or who have no acceptable standard treatment options; patients with ovarian cancer should have one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, biologic/targeted (non-cytotoxic) agents or extended therapy administered after surgical or non-surgical assessment; ovarian cancer patients with both platinum-sensitive and platinum-resistant disease are eligible; patients with platinum-refractory disease are NOT eligible; definitions:\r\n* Platinum sensitive ovarian cancer is defined as patients who respond to platinum-based therapy (complete or partial) and then progress/recur more than 6 months after their last platinum dose (i.e., platinum-free interval is > 6 months)\r\n* Platinum resistant ovarian cancer is defined as patients who respond to platinum-based therapy (complete or partial) and then progress/recur within 6 months of their last platinum dose (i.e., platinum-free interval is =< 6 months)\r\n* Platinum refractory ovarian cancer is defined as patients who have progression of disease while receiving platinum-based chemotherapy or who fail to achieve at least a partial response to platinum-based chemotherapy (i.e., best response to platinum-based chemotherapy is stable disease)
Patients must have platinum-resistant ovarian cancer, defined as progression within 6 months from completion of a minimum of four cycles of platinum-containing therapy.
Patients with primary platinum-refractory disease
Progressed or recurred within 12 months of completing platinum therapy or received > 1 prior line of platinum therapy for breast cancer in any setting (adjuvant or neoadjuvant).
Subjects who had objective disease progression while receiving platinum chemotherapy administered for locally advanced or metastatic disease; subjects who received low-dose platinum therapy administered in combination with radiation therapy are not excluded
Subjects who have received platinum in the adjuvant or neoadjuvant setting are eligible; however, subjects may not have relapsed within 6 months of the last dose of prior platinum therapy
Patients must have any epithelial (ie, serous, endometroid, mucinous, clear cell) ovarian, fallopian tube, or primary peritoneal cancer. Patients must have experienced a response lasting at least 6 months to first-line platinum-based therapy but currently considered to have platinum-resistant disease per investigator's assessment (e.g, patient is not eligible for further platinum containing treatment). Patients may have received up to 5 lines of cytotoxic therapy for advanced or metastatic cancer. Neoadjuvant and adjuvant therapies are not counted towards lines of therapy.
Patients must have with high-grade serous or endometroid ovarian, fallopian tube, or primary peritoneal cancer. Patients must have experienced a response lasting at least 6 months to first-line platinum-based therapy but currently considered to have platinum-resistant disease per investigator's assessment (e.g, patient is not eligible for further platinum containing treatment). Patients may have had up to 4 lines of cytotoxic therapy for advanced or metastatic cancer. Neoadjuvant, adjuvant, and the combination of both will be considered as one line of therapy.
Patients with primary platinum refractory ovarian cancer (ie, progressive disease on or within 6 months of first-line platinum therapy)
Platinum resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively.
Received up to 3 lines of systemic anticancer therapy for platinum sensitive disease, most recently platinum containing, and no prior systemic therapy for platinum resistant disease
Prior hypersensitivity to platinum chemotherapy or to any of the excipients of platinum or nivolumab therapy
Platinum-refractory disease (progression during the first platinum-based chemotherapy)
Patients must be platinum-resistant (platinum-free interval < 6 months) or have platinum-refractory disease as per Gynecologic Cancer Intergroup Committee (GCIC) criteria; disease progression has to be radiologic or clinical; biomarker progression with CA125 after a platinum based regimen would not be sufficient evidence of disease progression; the patients must have had radiological progression to that regimen
Patients may have either platinum sensitive or platinum resistant recurrent ovarian cancer
Histologically confirmed recurrent ovarian, fallopian tube or primary peritoneal carcinoma or endometrial cancer in post-menopausal women; NOTE: pure clear cell and pure mucinous carcinomas are ineligible; platinum sensitive, platinum resistant and platinum refractory disease are eligible; no limitations in the number of prior regimens
Treatment with prior platinum therapy
Patients must have received at least 2 prior platinum based lines of chemotherapy - Patients must be partially platinum sensitive or platinum sensitive
Patients who have platinum resistant or refractory disease
Tumor progression or recurrence within 6 months of last dose of platinum therapy in the primary treatment setting
Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation, or extended therapy administered after completion of initial chemotherapy; patients must be considered platinum resistant or refractory according to standard Gynecologic Oncology Group (GOG) criteria, i.e., have had a treatment-free interval following platinum of less than 6 months, have persistent disease at the completion of primary platinum-based therapy or have progressed during platinum-based therapy; patients with greater than 6 month disease free interval after completion of primary therapy must have received a second platinum based regimen, and have persistent or progressive disease, or disease that recurs within 12 months of completion of second line platinum-based therapy; patients who are unable to receive platinum-based therapy for recurrent disease would also be eligible
Patients must have platinum-resistant disease, (defined as progression within < 6 months from completion of a minimum of 4 platinum therapy cycles (+ 7 days); the date should be calculated from the last administered dose of platinum therapy)
Platinum-free interval (PFI) - patients must have progressed < 12 months after completion of their last platinum-based chemotherapy; the date (platinum free interval) should be calculated from the last administered dose of platinum therapy to documentation of progression
Prior chemotherapy: Cohort 1) PR or CR to prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or Cohort 2) > 2 prior chemotherapy regimens for metastatic disease and no prior platinum for metastatic disease
Patients with platinum resistant cancer
If the patient has platinum-sensitive relapsed disease (first relapse > 6 months from end of initial platinum disease), the patient should have been re-treated with platinum for relapsed disease (or be intolerant or have refused such treatment).
Recurrent platinum-resistant disease, defined as disease progression within 6 months (182 days) of the last receipt of platinum-based chemotherapy
Participants with platinum-resistant or platinum-sensitive disease (within 12 months) are eligible; platinum-resistant disease is defined as relapse within 6 months after the last dose of platinum-based chemotherapy; platinum-sensitive disease is defined as relapse greater than 6 months after the last dose of platinum-based chemotherapy; participants with platinum-sensitive disease who have experienced relapse within 6 to 12 months after the last dose of platinum-based chemotherapy are eligible; participants with primary platinum-refractory disease (defined as progression during or relapsed within 2 months of their initial platinum-based chemotherapy) are not eligible
Patients with primary platinum-refractory disease are ineligible; primary platinum-refractory disease is defined as relapse less than 2 months after initial platinum-based chemotherapy
Patients with platinum-sensitive disease with relapse greater than 12 months after the last dose of platinum-based chemotherapy are ineligible
Patients must have platinum resistant cancer with a platinum free interval of < 6 months; progression after last platinum is based on investigator assessment
Patients cannot have primary platinum refractory cancer, i.e. documented cancer progression while receiving platinum or within one month of receipt of a platinum based regimen
Subjects must have recurrent or persistent platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with measureable disease (as defined by RECIST 1.1.) who have received at least one prior platinum-based therapy\r\n* Platinum-based therapy is defined as treatment with carboplatin, cisplatin or another organoplatinum compound\r\n* Platinum-resistant is defined as having had disease progression within 6 months or most recent platinum therapy, or having disease progression while receiving previous platinum-based chemotherapy\r\n* Histologic documentation of diagnosis of carcinoma is required and the following histologic subtypes are eligible: high grade serous, clear cell, endometrioid, carcinoma, adenocarcinoma, mixed (including above subtypes only)
Participants who are allergic to any platinum agent
Platinum-sensitive ovarian cancer defined by recurrence or progression of disease > 6 AND < 24 months after completion of the most recent platinum-based therapy.
Evidence of platinum-refractory ovarian cancer defined as recurrence or progression during the first 6 cycles of or < 6 months after the beginning of first-line platinum based chemotherapy.
Evidence of platinum-resistant ovarian cancer defined as recurrence or progression within 6 months after completing the most recent platinum-based therapy.
Disease must have been persistent or have recurred within 6 months (182 days) of a prior platinum therapy; disease may not have progressed during prior platinum therapy (i.e. refractory)\r\n* Evidence of progression and the timing of progression or reoccurrence will be new measurable disease, RECIST defined progression, or first doubling of the CA-125 nadir (however, that will need a confirmatory CA-125 to be done at least 2 weeks or later and the patient will need to have “detectable disease”\r\n* While the disease must have been persistent or progressive within 6 months of a prior platinum therapy, the patient may be enrolled and begin treatment up to 12 months (365 days) after the last dose of platinum-based therapy
Subjects must have recurrent or persistent platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with measureable disease (as defined by RECIST 1.1.) after first or second line platinum-based chemotherapy, for which treatment with PLD is indicated. Platinum-based therapy is defined as treatment with carboplatin, cisplatin or another organoplatinum compound. Platinum-resistant is defined as having a platinum-free interval (PFI) of < 12 months after first- or second-line platinum-based chemotherapy, or having disease progression while receiving second-line platinum-based chemotherapy. Subjects are allowed to have received, but are not required to have received:
Subjects with platinum-refractory disease, defined as disease progression while receiving first line platinum-based therapy.
Platinum-resistant disease (PFI: 1-6 months after last platinum-containing chemotherapy).
For platinum-resistant or -refractory cohort\r\n* Disease that has progressed within 6 months of the last receipt of platinum-based chemotherapy\r\n* No more than 1 prior line of therapy in the platinum-resistant/-refractory setting\r\n* No limit on number of prior lines received in the platinum-sensitive setting prior to development of platinum-resistance (defined as disease progression within 6 months of platinum-based chemotherapy)
Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease; platinum sensitive and resistant patients are eligible
Histologically confirmed estrogen receptor positive (greater than 10%) recurrent ovarian, fallopian tube or primary peritoneal carcinoma in post-menopausal women; note: pure clear cell and pure mucinous carcinomas are ineligible; both platinum sensitive, platinum resistant and platinum refractory disease are eligible; no limitations in the number of prior regimens
Failure of prior platinum therapy
Ovarian cancer patients with both platinum-sensitive and platinum-resistant disease are eligible; ovarian cancer patients with platinum refractory disease (failure to achieve a complete response to first line platinum therapy) are ineligible
Patients who have received at least 2 previous lines of platinum containing therapy prior to randomisation For the penultimate chemotherapy course prior to enrolment on the study: • Patient defined as platinum sensitive after this treatment; defined as disease progression greater than 6 months after completion of their last dose of platinum chemotherapy For the last chemotherapy course immediately prior to randomisation on the study:
Known standard therapy for the patient’s disease that is potentially curative or definitely capable of extending life expectancy; note: patients with recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube will be allowed, if the investigator believes the study treatment is a better alternative to initiation platinum-based chemotherapy, such as patients with a prior platinum allergy or low volume disease for whom platinum-based therapy is deferred until a later date
Must have had prior platinum or platinum based therapy.
Platinum resistant or refractory disease within 6 months of completing or while receiving a platinum and taxane containing regimen
Patients may be platinum-sensitive or resistant; group A (monotherapy cohort); participants may have received up to 3 prior cytotoxic chemotherapies, i.e., second or third line; there is no limit to the number of lines of prior biologic or hormonal therapies they may have had; patients may be platinum-sensitive or resistant or refractory
Participants must have platinum-resistant disease, (defined as progression within < 6 months from completion of a minimum of 4 platinum therapy cycles; the date should be calculated from the last administered dose of platinum therapy)
Patients whose disease was refractory to their previous platinum treatment; refractory disease is defined as those patients who progressed during the preceding platinum treatment
Patients with platinum-sensitive or platinum-resistant disease defined by recurrence or progression of disease > 6 months or =< than 6 months after completion of frontline platinum based chemotherapy
Subject is platinum sensitive (progression free interval >= 6 months prior to recent recurrence) or platinum resistant (progression free interval < 6 months prior to recent recurrence)
Subjects must be partially-platinum-sensitive (defined as progression 6 to 12 months after the end of the last platinum-based chemotherapy) or platinum sensitive (defined as progression > 12 months after the end of the last platinum-based chemotherapy);
Subjects who have platinum-resistant or refractory disease defined as progression during or within 6 months of the last platinum-based chemotherapy;
PRIOR THERAPY PHASE II:\r\n* Prior chemotherapy must have included a first-line platinum-based regimen with or without intravenous consolidation chemotherapy\r\n* Prior hormonal-based therapy for ovarian, primary peritoneal serous, or fallopian tube cancer is acceptable\r\n* Patients may not have previously received a PARP-inhibitor; prior treatment with BSI-201 is allowed\r\n* Patients may not have had a prior anti-angiogenic agent in the recurrent setting\r\n* Patients may have received up to 1 non-platinum-based line of therapy in the recurrent setting\r\n* Patients may have received an unlimited number of platinum-based therapies in the recurrent setting\r\n* Patients should have platinum-sensitive disease, where platinum-sensitive disease is defined as having had a > 6 month interval since last receiving platinum therapy prior to disease recurrence; patients must have had a prior response while on the platinum-containing regimen and cannot have experienced disease progression while receiving platinum
Subjects initially treated with a platinum regimen for Stage IIIB disease who later develop metastatic disease and are re-treated with a platinum regimen are allowed.
Patients must be platinum resistant defined as progressive disease while receiving platinum therapy or within 6 months of completing first line platinum therapy or patients who have progressive disease after two lines of platinum-based treatment
Patients must have platinum-refractory disease defined as disease progression within 12 months platinum-based chemoradiation with curative intent or any disease progression on platinum-based chemotherapy in the absence of radiation.
Recurrent platinum-sensitive disease, defined as disease progression ?6 months after completing a minimum of 4 cycles of a platinum-containing regimen
Subjects with serous ovarian/fallopian tube/primary peritoneal, granulosa cell tumors or clear cell tumors considered platinum refractory/resistant, defined as having at least one prior platinum-based chemotherapeutic regimen with a subsequent platinum-free interval of < 12 months, having progression during platinum-based therapy, or having persistent disease after a platinum-based therapy, are eligible. Intolerant subjects, defined as unable to receive further platinum due to toxicity, are eligible.
Has received at least 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 6 month period between penultimate platinum regimen and progression of disease)
Has responded to last the platinum regimen, remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen
Platinum-refractory germ-cell tumors.
platinum-refractory cancer, defined as disease failed to achieve at least a partial response to a platinum-containing regimen (i.e., stable disease or actual disease progression), AND
Platinum resistant/refractory disease, defined as disease progression/relapse within 6 months following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively
Patients whose ovarian cancer recurs/progresses within 0-6 months following platinum-based chemotherapy have platinum resistant disease; such patients are eligible for this trial
Patients with documented disease recurrence/progression within 6-12 months of completing platinum-based therapy, are considered to have ‘borderline' platinum sensitivity; these patients are eligible for this trial if agreed by the patient and the treating physician
Patients who relapse more than 12 months after completion of platinum-based treatment are considered ‘platinum sensitive’ and will not be eligible for this trial
Subjects must have platinum resistant disease (i.e., which is defined as disease progression in less than 6 months after receiving a minimum of 4 cycles of a platinum containing regimen).
Histologically confirmed diagnosis of epithelial ovarian, fallopian tube or primary peritoneal cancer (measurable or evaluable, nonmeasurable disease) that is platinum-resistant or refractory. In the judgment of the Investigator, a patient who is platinum-sensitive but would not benefit from further platinum treatment is also eligible.
Platinum-treated patient that progressed while on or within less than 8 weeks from the last day of platinum administration
For Stage 2: Participants with non-mucinous, platinum-resistant ovarian cancer with documented radiographic progression or relapse according to RECIST within 6 months of receiving platinum-based chemotherapy
Participants who are allergic to platinum agent
Refractory to platinum-based therapy (defined as disease progression within 6 months of last dose of platinum chemotherapy)
For the dose expansion cohort, patients with ovarian, fallopian tube or primary peritoneal cancer must have platinum resistant disease defined as progression within 6 months after last platinum regimen; platinum refractory disease is allowed
PATIENTS: Platinum-resistant ovarian cancer or recurrent ovarian cancer as described below\r\n* Platinum-resistant disease is defined as:\r\n** Recurrent disease < 6 months from end of platinum-based chemotherapy or\r\n** Progression of disease while on first line platinum-based chemotherapy or\r\n** Initially platinum-sensitive disease that becomes platinum-resistant during treatment\r\n* Recurrent ovarian cancer with any one significant clinical event following completion of chemotherapy:\r\n** Ascites\r\n** Bowel obstruction\r\n** Pleural effusion
Participants in Cohort 1 must have had an objective response to prior platinum-based therapy with subsequent progression ?90 days after the last dose of platinum
Participants in Cohort 2 must have either not had an objective response to prior platinum based therapy or had progression <90 days after the last dose of platinum
Primary platinum refractory
Patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer must also meet the following criteria: a. Must be either platinum-resistant or platinum-refractory according to the following definitions:(1)Platinum-resistant: a response to platinum therapy followed by progression within 6 months after completing therapy (2)Platinum-refractory: best response of stable disease or progression during platinum therapy; b. Must have had prior systemic treatment with a taxane; c. Must have received no more than 4 prior systemic cytotoxic regimens
Patient must have suspected platinum-resistant disease (disease progression =< 6 months of platinum therapy)
Platinum-sensitive SCLC after having received up to two prior lines of anticancer therapy, including at least one prior line of a platinum (monotherapy or platinum containing chemotherapy regimen). Patients are eligible only if they had a response (partial or complete) to their most recent platinum and their disease progressed greater than 60 days after completing their most recent platinum. Patients may have received another non-platinum containing regimen, such as topetecan, immunotherapy, or an investigational agent, as their most recent line of therapy, so long as they are deemed platinum sensitive per the above definition.
Disease must have progressed after treatment with a platinum-containing regimen and should be defined as one of the following: i. disease progression or recurrence between 3 to 6 months of prior curatively intended multimodal therapy (which includes platinum therapy) for locoregionally advanced SCCHN. ii. disease progression or recurrence after prior platinum therapy in the recurrent or metastatic setting Note: This criterion is only applicable for subjects who have not had treatment in the recurrent/metastatic setting
If the participant has received prior therapy with platinum, the time to the first treatment of study drug from the last platinum exposure is >28 days.
If the participant has received prior therapy with platinum, the time to the first treatment of study drug from the last platinum exposure is >28 days.
Documented platinum-resistant or platinum-refractory disease. Platinum-resistant disease is defined as progression within < 6 months from completion of a minimum of 4 platinum frontline therapy cycles in the pre or postoperative setting (the date should be calculated from the last administered dose of platinum agent). Platinum-refractory is defined as disease that has recurred/progressed while receiving platinum-based frontline therapy.
Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen
No prior taxane therapy =< 6 months, except as a radiosensitizer
Planned neoadjuvant treatment with anthracycline and taxane containing chemotherapy
Participants eligible for taxane monotherapy
Prior taxane is allowed (as long as the patient is not experiencing grade > 1 neuropathy and had no history of disease progression on a taxane therapy within 3 months prior to study enrollment)
Patients who were previously treated with standard anthracycline- and/or taxane-based chemotherapy will be recruited for this study
Received any chemotherapy (including irinotecan) other than platinum and fluoropyrimidine with or without anthracycline or taxane for advanced gastric or GEJ adenocarcinoma
Experienced disease progression after having received at least 1 but no more than 2 prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based chemotherapy, for castration-resistant disease
At least 1 line of taxane-based chemotherapy for the treatment of prostate cancer with documented evidence of disease progression while on therapy or within 3 months after discontinuation of therapy in the castrate-resistant setting
No prior treatment with an anthracycline and taxane
Prior use of taxane-based chemotherapy for treatment of castrate resistant prostate cancer.
Prior treatment with a taxane is not permitted in the dose-expansion phase. Patients in the dose escalation component may have received a taxane in the peri-operative setting, provided they developed disease recurrence >6 months after the completion of this therapy
Previous treatment with 1 or 2 chemotherapy regimens including at least 1 taxane-based regimen for metastatic (non castrate or castrate) prostate cancer. Patients may have received radium-223 and/or cabazitaxel, or were deemed unsuitable, declined, or did not have access to these therapies.
Last dose of any systemic non-taxane cytotoxic chemotherapy completed at least one day prior to Day 1. Last dose of any systemic taxane cytotoxic chemotherapy completed at least 4 weeks prior to Day 1
Previous systemic cytotoxic treatment for prostate cancer (eg: taxane-based regimen);
Patients who received prior taxane-based chemotherapy as neoadjuvant or adjuvant therapy for local disease, or who received taxane-based therapy in the PSA clinical (non-metastatic) state is allowable provided that the total duration of exposure was six cycles or less and chemotherapy was completed more than 6 months prior to registration
Taxane-based chemotherapy that was aborted due to allergic reactions or intolerance to chemotherapy and therefore received 1 cycle of prior therapy is allowable
Prior exposure to a taxane (paclitaxel or docetaxel)-based regimen in localized or advanced/metastatic setting.
Previous treatment with any weekly taxane regimen.
Previous therapy for any malignancy with an anthracycline or taxane for Cohorts A and B and carboplatin for Cohort A
At least 1 line of prior taxane-based chemotherapy
Have received standard of care frontline surgical and chemotherapy treatment (at least six cycles of platinum and taxane therapy); patients who received neoadjuvant therapy are included
Taxane therapy within the past 3 months (90 days) prior to study day 1
Patients previously treated with taxanes are excluded, unless the taxane therapy was part of an initially curative regimen (e.g. adjuvant) and was completed > 12 months from study enrollment; patients with previous intolerance to ramucirumab
Prior severe infusion reaction (bronchospasm, stridor, urticaria and/or hypotension) to a taxane therapy
Prior anthracycline, platinum salt, or taxane for any malignancy
Patients must have received a taxane as part of their prior treatment
Patients must have received at least one prior chemotherapy regimen for metastatic disease\r\n* NOTE: Patients who received anthracycline and taxane containing adjuvant or neoadjuvant therapy and progressed within 12 months may enter this trial as their first therapy for metastatic breast cancer (MBC)
Patients previously treated with docetaxel for NSCLC or with known severe hypersensitivity to taxane therapies.
History of hypersensitivity to a taxane
Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid
Subjects who have received prior taxane therapy in the metastatic setting
More than one prior taxane regimen at any stage of the disease under study (“taxane” refers to paclitaxel, docetaxel, abraxane and cabazitaxel); adjuvant and/or neoadjuvant treatments are considered together as one prior regimen
Prior treatment may include a taxane as per the following criteria:\r\n* Prior taxane (including paclitaxel) in the adjuvant or neoadjuvant setting is allowed, provided that the interval between the completion of (neo)adjuvant therapy and disease recurrence is > 12 months\r\n* Prior taxane in the metastatic setting is allowed, provided that the agent administered in the metastatic setting was not standard paclitaxel
One to two line(s) of prior taxane-based chemotherapy allowed. If docetaxel chemotherapy is used more than once, this will be considered as one regimen.
One prior regimen/line of a taxane-containing regimen for mCRPC or refusal or ineligibility of a taxane-containing regimen
Patient with progressive disease during first line chemotherapy with a platinum/taxane combination will be excluded
All patients must have previously received trastuzumab and a taxane, separately or in combination and have received prior therapy for metastatic disease
Must have received prior anthracyline and taxane compound therapy unless clinically contraindicated
Receipt of a taxane for adjuvant therapy or metastatic disease in the last 12 months
Prior anthracycline or taxane
Recurrent disease within 12 months after completion of adjuvant chemotherapy containing a weekly taxane
Patients must be able to receive taxane and/or anthracycline based chemotherapy
Patients must have had a complete response to front-line platinum-taxane therapy (at least three cycles)
Eligible for treatment with a taxane-containing regimen (for example, docetaxel), unless taxane-containing regimen was declined after an informed decision
The participant received combination chemotherapy, which must include a platinum and/or a fluoropyrimidine and must not include a taxane or antiangiogenic agent.
Subjects must have received a platinum-taxane-based regimen as first-line therapy.
Prior taxane therapy administered for the treatment of metastatic breast cancer with the below exceptions.
Prior taxane therapy for metastatic breast cancer is allowed if the patient received ? 1 full cycle (i.e., therapy discontinued within 4 weeks for subjects receiving weekly paclitaxel or Abraxane; therapy discontinued within 3 weeks for subjects receiving paclitaxel or docetaxel every 3 weeks) in the absence of progression or if taxane therapy for metastatic disease was > 12 months prior to C1D-2.
Prior treatment with a taxane and/or anthracycline in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated
must have received a taxane in any disease setting
Previously treated with an anthracycline and/or taxane in the neoadjuvant/adjuvant or metastatic setting
For gastric or GEJ adenocarcinoma, prior treatment with any taxane
For RCC, at least two prior anticancer regimens (one must be a VEGF-targeted TKI), or are otherwise inappropriate candidates for all approved therapies. For OCCC, at least one line of prior therapy with a platinum and taxane regimen.
For inclusion in Cohort 1, mCRPC patients must have progressed while receiving (or subsequent to receiving) abiraterone and/or enzalutamide but must not have previously received taxane-based systemic chemotherapy for mCRPC (previous treatment with six cycles of docetaxel for metastatic castration-sensitive prostate cancer (mCSPC) is permissible). NOTE: patients receiving fewer than 2 cycles of taxane based regimen due to intolerance are eligible for cohort 1.
Patients who have received a taxane based treatment or abiraterone, within 4 weeks before start of study treatment.
Patients that have received prior taxane-based chemotherapy or abiraterone in any setting will not be eligible for the expansion cohort. Additional exclusion criterion for patients undergoing tumour biopsy:
Prior taxane or anthracycline chemotherapy for malignancy
Progression of disease after the most recent anticancer treatment. At least 1 prior chemotherapy regimen must have included a taxane.
Prior chemotherapy regimens must include a platinum and/or a fluoropyrimidine component and must not include a taxane or antiangiogenic agent.
Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
History of prior therapy with trastuzumab and a taxane, separately or in combination. For patients in dose escalation and MTD expansion cohorts, prior therapy with trastuzumab and a taxane must have been for metastatic disease. For patients in CNS disease expansion cohorts, trastuzumab and taxane (together or separately) may have been given at any time prior to study enrollment as part of neoadjuvant therapy, adjuvant therapy, or therapy for metastatic disease.
No treatment with prior taxane-based chemotherapy for metastatic disease\r\n* Patients who received prior taxane-based chemotherapy as neoadjuvant or adjuvant therapy for local disease, or who received taxane-based therapy in the PSA clinical (non-metastatic) state is allowable provided that the total duration of exposure was six cycles or less and chemotherapy was completed more than 6 months prior to registration\r\n* Taxane-based chemotherapy that was aborted due to allergic reactions or intolerance to chemotherapy and therefore received 1 cycle of prior therapy is allowable
If a patient has HER2-positive breast cancer, herceptin and pertuzumab will be given along with taxane therapy
Prior taxane therapy for any indication
Patients who will receive CXRT with platinum/taxane-based chemotherapy and with a total radiation dose of >or = 50 Gy, per treating physician's assessment
Prior taxane therapy for metastatic breast cancer.
EXPANSION COHORT ONLY: Previously treated with at least one and not more than 3 lines of systemic chemotherapy including at least one of the following: a platinum agent, a taxane, or gemcitabine
Has received prior systemic treatment with a taxane for advanced/metastatic disease
Patients with grade > 2 neuropathy attributable to previous administration of taxane chemotherapy
More than 1 prior chemotherapy regimen (a subject who received first- line carboplatin and taxane and then receives the same taxane second- line will be considered to have had 1 prior chemotherapy regimen)
Less than three months since last taxane-containing therapy.
have not been treated with a taxane within six months of C1D1, AND
Prior history of hypersensitivity to taxane or platinum therapy; if either agent was previously administered, the patient must have tolerated it well and have recovered from any adverse events
Known significant dose delays during prior treatment with a taxane due to drug-related toxicities
5. Patients with advanced, recurrent or metastatic endometrial cancer who have received one chemotherapeutic regimen with platinum and taxane (either as adjuvant or as first line treatment) and who have progressed.
Subject must have had at least one prior cytotoxic chemotherapy regimen for unresectable or metastatic disease. Prior taxane therapy is allowed.
Has received prior taxane therapy
Patients must not have received any prior taxane or platinum based chemotherapy
Currently receiving taxane-based chemotherapy (either adjuvant or neoadjuvant)
Subjects receiving chemotherapy with concurrent anthracycline and taxane (AT or Taxotere-Adriamycin-Cytoxan [TAC])
Allowable planned chemotherapy regimens (with or without ovarian suppression) are:\r\n* 6 cycles of a taxane (T) anthracycline (A) and cyclophosphamide (C)\r\n* 4 cycles of an anthracycline and cyclophosphamide plus 4 cycles of a taxane\r\n* 6 cycles of a taxane plus a platinum analogue with or without one or more human epidermal growth factor receptor 2 (HeR-2) targeted therapies such as trastuzumab +/- pertuzumab\r\n* 6 cycles of an anthracycline plus a taxane\r\n* 6 cycles of cyclophosphamide, an anthracycline and fluorouracil
Has received a platinum compound and/or a taxane
Relapsed after or are refractory to at least one prior line of chemotherapy which have not included a taxane (with the exception of Cohort 3 of the Lead-In Phase which will allow the enrollment of subjects with prior treatment with a taxane)
Scheduled to undergo adjuvant taxane-based chemotherapy as single agents or in combination with platins or HER-2 directed therapy
Treatment with any neuropathic agent including taxane, platinum, vinca alkaloid, or bortezomib chemotherapy in the past 6 months
Treatment with any neuropathic agent including taxane, platinum, vinca alkaloid, or bortezomib chemotherapy in the past 6 months
Patients not eligible for chemotherapy with taxane and/or anthracycline based chemotherapy regimens
Prior treatment with a taxane in the metastatic setting
Patients who are scheduled to receive a taxane-based regimen for a histologically confirmed solid tumor that is:
Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen
Previously or currently receiving taxane-based chemotherapy
Clinical symptoms of peripheral neuropathy noted in medical record and suspected to be secondary to taxane-based therapy
Patient must agree to receive standard or dose-dense adriamyacin, cyclophosphamide, and taxane-based\r\nchemotherapy given preoperatively
Prior treatment must include an anthracycline and/or a taxane in the neoadjuvant, adjuvant, or metastatic setting with the exception for participants who are clinically contraindicated for these chemotherapies.
Has received prior therapy with any taxane chemotherapy
Patients must have progressed during or after prior platinum-based chemotherapy; patients whose only prior platinum-based chemotherapy regimen was for stage I-III disease (i.e. patient has not received any platinum-based chemotherapy for stage IV or recurrent disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy; patients must have experienced disease progression during or after prior anti-PD-1 or anti-PD-L1 antibody monotherapy as their most recent line of treatment; prior PD-1/PD-L1 combination therapy is not permitted
Patients must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment; patients will either consent to the screening consent or the pre-screening consent, not both; these criteria are:\r\n* Screening at progression on prior treatment: to be eligible for screening at progression, patients must have received at least one line of systemic therapy for any stage of disease (stages I-IV) and must have progressed during or following their most recent line of therapy; for patients whose prior systemic therapy was for stage I-III disease only (i.e. patient has not received any treatment for stage IV or recurrent disease), the prior systemic therapy must have been a platinum-based chemotherapy regimen and disease progression on the platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy; for patients whose prior therapy was for stage IV or recurrent disease, the patient must have received at least one line of a platinum-based chemotherapy regimen or checkpoint inhibitor therapy (e.g. nivolumab or pembrolizumab)\r\n* Pre-screening prior to progression on current treatment: to be eligible for pre-screening, current treatment must be for stage IV or recurrent disease and patient must have received at least one dose of the current regimen; patients must have previously received or currently be receiving a platinum-based chemotherapy regimen or checkpoint inhibitor therapy (e.g. nivolumab or pembrolizumab); patients on first-line platinum-based treatment are eligible upon receiving cycle 1, day 1 infusion; Note: patients will not receive their sub-study assignment until they progress and the S1400 Notice of Progression is submitted
Patients must have received first-line/induction systemic therapy comprising of immunotherapy and/or platinum-based chemotherapy (a total of 4 cycles or courses), and achieved stable disease or a partial response.
The small cell lung cancer must have progressed radiographically following a platinum-based (cisplatin and/or carboplatin) standard prior chemotherapy regimen; any number of interval prior lines of therapy is allowed; patients who have received prior platinum-based chemotherapy and radiation for limited stage SCLC and have subsequently developed relapsed disease are eligible, as long as the platinum-based therapy was given within 12 months prior to the time of relapse
Prior lines of therapy must include a platinum-based therapy. Investigational agents used in combination with standard therapies are allowed. Participants who received platinum-based neoadjuvant or adjuvant therapy and subsequently received platinum-based therapy as first-line therapy are eligible.
Subjects with NPC must have received, or been intolerant to, a platinum-based combination as part of their prior therapy for advanced/metastatic disease;
Patients with esophageal cancer must have received, or been intolerant to, a platinum-based combination as part of their prior therapy for advanced/metastatic disease;
Have not tolerated or have progressed or relapsed on or within 6 months of platinum-based chemotherapy
Has received more than 2 platinum-based regimens against SCLC
Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC): Part A: RR SCLC who progressed or recurred following platinum-based chemotherapy; Note: Subjects with a diagnosis of combined small cell carcinoma with >50% small cells may be considered for inclusion in the dose escalation phase of part A based on investigator discretion and after discussion with the medical monitor Part B: ED SCLC with ongoing clinical benefit (stable disease [SD], partial response [PR], or complete response [CR]) following no more than 6 cycles of first-line platinum-based chemotherapy with the last dose of chemotherapy greater then equal to 28 days prior to the study day 1 (first-line consolidation setting)
Cohort A Dose Expansion (Ribociclib + PDR001): Prior chemotherapy: \r\n* Participants may have received any number of prior lines of chemotherapy for metastatic disease, as long as the last dose is >= 21 days prior to first dose of study treatment\r\n** Must have received a first-line platinum-based therapy and have disease that is platinum-resistant \r\n*** Platinum-resistant disease is defined as disease relapse within 2 to 6 months of prior platinum-based chemotherapy\r\n** Must have received a first-line platinum-based chemotherapy regimen and have relapsed despite standard therapy
Patients who have not previously been treated with platinum-based based doublet chemotherapy and who, in the judgment of the investigator, have rapidly progressive disease such that serious complications may arise from disease progression within the next 12 weeks will be excluded
Participants in all combination therapy arms must have recurrent or metastatic NSCLC and previously received platinum-based therapy and progressed either during or after anti-programmed death ligand 1 (PDL1)-based therapy. In addition, participants must have received only one prior immunotherapy.
Prior therapy allowed:\r\n* At least one and no more than 3 platinum based chemotherapy regimens\r\n* Up to 2 non-platinum, cytotoxic regimen\r\n* There is no limit on use of prior biological therapies (hormonal or targeted therapy)\r\n* NOTE: Prior immunotherapy is not allowed
Stage IIIB or IV patients must have progressed after first line platinum based chemotherapy; patients with stage I-IIIB NSCLC who have progressed within 6 months of a full dose platinum based regimen as adjuvant therapy or with radiotherapy are eligible; patients who received weekly low dose chemotherapy with radiation only are not eligible
Patients with primary mediastinal non seminomatous germ cell tumor are eligible if they have received first line platinum based chemotherapy and their recurrence is not amenable to surgical resection based on the treating physician’s expert opinion
Patients with late relapse (> 2 years) of non seminomatous germ cell tumors are eligible if they have received first line platinum based chemotherapy and their recurrence is not amenable to surgical resection based on the treating physician’s expert opinion
NSCLC - Prior treatment regimens must include a platinum-based therapy
Concomitant EGFR TKI and platinum based chemotherapy as first line regimen.
Platinum-based chemotherapy as first line treatment
Patients must have had one prior taxane and platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, non-cytotoxic (biologic/targeted agents) or extended therapy administered after surgical or non-surgical assessment; there is no maximum number of prior regimens; Note: use of bevacizumab as maintenance therapy after initial adjuvant platinum-based chemotherapy is allowed so long as platinum-resistant recurrence occurred subsequent to a separate platinum-based regimen AND more than 6 months after completion of bevacizumab maintenance
PHASE II INCLUSION CRITERIA: Patients must have cytologically or histologically confirmed ES-SCLC and must not have progressed after first line platinum-based chemotherapy regimen before randomization
Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 3 months before Day 1 or more than 6 months prior to Day 1 if platinum-based
Prior platinum-based chemotherapy
Disease progression after treatment with at least one line of chemotherapy that included a platinum agent in combination with pemetrexed
Participants who have received prior platinum chemotherapy
Participants must have adequate organ and marrow function as defined below both prior to administration of RRx-001 and prior to administration of platinum doublet based regimen:
History of needing to permanently discontinue prior platinum doublet-based regimen for toxicity (e.g., cisplatin causing renal impairment, ototoxicity, or severe neuropathy).
All patients must have received a prior platinum-based chemotherapy regimen for treatment of urothelial cancer and must now be considered refractory to platinum-based chemotherapy; patients may have received the platinum-containing regimen either in the peri-operative or metastatic setting; patients may have received any number of additional prior therapies, and may have received prior immune therapies
Patients must have received prior platinum and pemetrexed based therapies. Response to platinum is not an eligibility criterion for enrollment
Have experienced progressive disease after at least one previous regimen of platinum-based chemotherapy
Must have received and have progressed, or are intolerant to at least one systemic regimen (platinum- or fluoropyrimidine-based chemotherapy regimen for metastatic or recurrent disease or progressed within 6 month of completion of adjuvant therapy with a platinum- or fluoropyrimidine-based regimen)
Prior platinum-based chemotherapy for the treatment of prostate cancer
Patients who did not achieve PR or CR as per the Lugano criteria following at least 1 cycle of platinum?based salvage chemotherapy, or patients not eligible for platinum based therapy or beam induction therapy due to decreased ejection fraction (< 40%)
Prior disease progression while receiving platinum chemotherapy; or any platinum chemotherapy within the last 6 months\r\n* For all patients (except breast cancer patients) who received platinum-based adjuvant or neo-adjuvant chemotherapy, at least 6 months must have passed between the last dose of platinum-based therapy and the development of metastatic disease\r\n* For breast cancer patients, at least 12 months must have passed between the last dose of platinum-based adjuvant or neo-adjuvant therapy and the development of metastatic disease
Patients with recurrent disease > 6 months after adjuvant or neoadjuvant platinum- based chemotherapy, who also subsequently progressed during or after a platinum- doublet regimen given to treat the recurrence, are not excluded.
STUDY TREATMENT: Platinum-based chemotherapy prior to chemoradiation is permitted but not mandatory
Any number of prior treatments is allowed; must have failed at least one treatment regimen for metastatic disease and must have failed platinum-based chemotherapy (including as treatment for localized disease) or be deemed ineligible for platinum-based therapy by the treating medical oncologist
Prior treatment with a PARP inhibitor, cyclophosphamide, or mitoxantrone chemotherapy. Patients who discontinued prior platinum based chemotherapy <=6 months prior to screening or whose disease previously progressed on platinum based therapy at any time in the past are also excluded.
Time from the last line of platinum-based chemotherapy of less than 6 months.
Disease that progressed while receiving initial line of platinum-based chemotherapy.
Subjects must have extensive-stage disease (by National Comprehensive Cancer Network [NCCN] criteria) that has been previously treated with first line platinum-based chemotherapy; patients must either have persistent or progressive disease after platinum based therapy
Disease has progressed or recurred during or less than 6 months after platinum-based chemotherapy at some point during the subject's course.
Patients must have had at least one prior line of platinum-based chemotherapy or patient must have refused cytotoxic chemotherapy; progressive disease must be documented prior to study entry and patients must have advanced, unresectable disease that is not amenable to surgical resection
Must have had at least 1 prior line of platinum-based therapy
One of the following:\r\n* Locally advanced or metastatic non-small cell lung cancer that has progressed after at least 1 line of platinum based chemotherapy\r\n** Patients may have received up to 2 prior lines of chemotherapy\r\n** Patients with actionable alterations in EGFR/ALK/ROS1/BRAF must also have progressed after treatment with a tyrosine kinase inhibitor appropriate for their genetic alteration\r\n** Untreated patients who refuse 1st line platinum based chemotherapy are also eligible\r\n* Squamous cell carcinoma of the head and neck whose disease has progressed after at least 1 line of platinum based chemotherapy\r\n** Patients may have received up to 2 prior lines of chemotherapy\r\n** Untreated patients who refuse 1st line platinum based chemotherapy are also eligible\r\n** Patients who relapse within 6 months of adjuvant cisplatin based concurrent chemoradiation, or neoadjuvant cisplatin based therapy can be considered eligible without an additional course of platinum chemotherapy for relapsed disease\r\n** Patients may have either locally recurrent or distant metastatic disease
Have a diagnosis of ovarian, fallopian tube, or primary peritoneal cancer patients who had a complete response to primary treatment with platinum based chemotherapy, have progressed within 6 months of completing platinum based chemotherapy and have subsequently received at least one, non-platinum-based, therapy
Ongoing response of stable disease or better following 4 cycles of platinum-based first line chemotherapy
Prior platinum-based chemotherapy for the treatment of prostate cancer
Up to three previous lines of therapy, of which one must have been a platinum-based doublet therapy and no more than two were cytotoxic chemotherapy
Relapse following platinum-based chemotherapy or documented progressive disease while on platinum-based chemotherapy
PHASE II SCLC: Have received and progressed during or after a platinum-based standard chemotherapy regimen and/or an immune-checkpoint inhibitor
UROTHELIAL CARCINOMA EXPANSION COHORT: Patient must have received at least one platinum based regimen of chemotherapy and/or an immune-checkpoint inhibitor if appropriate with progressive disease
Patients must have received at least one prior platinum-based chemotherapy for locally advanced or metastatic disease; prior bevacizumab as 1st line and/or maintenance therapy is allowed; prior nivolumab is allowed
Patient must have failed or found to be intolerant of standard frontline platinum-based regimens and must not have received > 2 prior lines of therapy (nota bene [NB]: retreatment with a platinum-based doublet for sensitive relapse counts as another line therapy; however substitution of cisplatin with carboplatin or vice versa due to toxicity does not count as a separate regimen)
Must be resistant to platinum-based chemotherapy (defined as progression on or after platinum-based chemotherapy given in the recurrent/metastatic setting).
PHASE I:\r\n* Patients must have received at least one course of platinum-based chemotherapy for the management of primary disease including carboplatin, cisplatin, or another platinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, biologic/targeted agents, or extended therapy administered after surgical or non-surgical assessment\r\n* There are no restrictions on the total number of prior regimens patients may have received
Patients are on treatment with a first line platinum-based (cisplatin, carboplatin or oxaliplatin) regimen for metastatic pancreas cancer, have received a minimum of 16 weeks of continuous platinum treatment and have no evidence of progression based on investigator's opinion.
Patients who have received platinum as potentially curative treatment for a prior cancer (eg ovarian cancer) or as adjuvant/neoadjuvant treatment for pancreas cancer are eligible provided at least 12 months have elapsed between the last dose of platinum-based treatment and initiation of the platinum-based chemotherapy for metastatic pancreas cancer.
Progression of tumour between start of first line platinum based chemotherapy for metastatic pancreas cancer and randomisation.
Not received more than 2 prior systemic therapies- one of which must have been a platinum based regimen- for primary or recurrent disease
Have been treated with debulking surgery and a first-line platinum-based chemotherapy regimen
Must have relapsed radiographically between 6 months and 36 months of completion of first-line platinum chemotherapy and should be randomized within 16 weeks of radiographic relapse
ARM B COHORT 2: Patients must have failed treatment with platinum based therapy with or without cetuximab; previous therapy with a platinum concurrent with radiation followed by progression of disease within 6 months will count as failure of one prior line of cisplatin based therapy
PRIOR THERAPY:\r\n* Patients must have had at least one prior taxane-platinum-based chemotherapeutic regimen for management of primary disease; the platinum could be carboplatin or cisplatin; the taxane could be paclitaxel, docetaxel, or nab-paclitaxel\r\n* Patients must have had a treatment-free interval following last line platinum-based therapy of less than 12 months, have progressed during platinum-based therapy, or had persistent disease after a platinum-based regimen\r\n* Patients may have received hormonal therapy for treatment of recurrent disease; this will not be counted as a cytotoxic regimen\r\n* Initial treatment may have included non-cytotoxic agents (biologic/targeted agents, such as bevacizumab)\r\n* Patients are allowed to have received prior therapy with tumor vaccines, immune checkpoint blockade (except anti-CTLA-4), or other cancer immunotherapy\r\n* Patients may not have previously received treatment with a PARP inhibitor
Subject has no evidence of disease based on radiographical imaging\r\n* Subject was deemed to have a complete objective response at completion of primary platinum-based chemotherapy by computed tomography (CT) scan and cancer antigen (CA)-125
Prior therapy:\r\n* Prior chemotherapy must have included a first-line platinum-based regimen with or without intravenous consolidation chemotherapy\r\n* Patients may have received an unlimited number of platinum-based therapies in the recurrent setting\r\n* Patients may have received up to 1 non-platinum-based line of therapy in the recurrent setting; prior hormonal therapy will not be considered to count as this non-platinum-based line\r\n* 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\r\n* Patients may not have previously received a poly adenosine diphosphate (ADP) ribose polymerase (PARP)-inhibitor\r\n* Prior hormonal-based therapy for ovarian, primary peritoneal, or fallopian tube cancer is acceptable
Patients must have completed front-line taxane/platinum-based therapy of their primary tumor with a progression free interval of greater than 6 months from last therapy and measurable relapsed disease must be present in the abdomen greater than 1 cm
Patients who have not previously been treated with platinum-based based doublet chemotherapy and who, in the judgment of the investigator, have rapidly progressive disease such that serious complications may arise from disease progression within the next 12 weeks will be excluded
First-line treatment with a standard platinum doublet chemotherapy regimen (carboplatin or cisplatin at standard dosing plus one of the following drugs at standard dosing: paclitaxel, docetaxel, vinblastine, vinorelbine, pemetrexed, or etoposide); patients who received platinum-based chemotherapy for localized lung cancer (either adjuvant chemotherapy following surgery or chemotherapy given in conjunction with definitive radiation) are eligible if their cancer has recurred within 6 months of platinum-based chemotherapy
Disease progression on platinum-doublet chemotherapy prior to enrollment
Patients may have received prior post-operative platinum based chemotherapy as per standard of care.
Subjects that progressed during or within one month of completion of first-line platinum-based chemotherapy will be excluded.
0-1 prior chemotherapy regimens for recurrent or advanced disease; platinum based chemotherapy administered as a radiation sensitizer agent is allowed and does not count as prior therapy
Prior treatment with platinum based doublet and checkpoint inhibitor
Patients must have had exactly one prior platinum/taxane-based chemotherapeutic regimen for management of primary disease, and must be in first relapse; first relapse must occur >= six months from completion of front-line platinum-based therapy; (time measured from last platinum dose; for example, patients receiving a biologic or chemotherapeutic agent after completion of platinum-based therapy as part of upfront therapy would be eligible based on time from last dose of platinum chemotherapy; in this situation, patients must be at least four weeks from last dose of a biologic agent); relapse cannot be based on rising cancer antigen (CA)- 125 alone; there must be radiographic evidence of recurrent disease
Completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the Investigator
Have had no more than one prior platinum-based regimen for metastatic disease NOTE: Maintenance therapy received after initial chemotherapy will not be considered additional chemotherapy and will be allowed; and
Patients must have progressive disease following prior therapy; specifically, patients must have progressed on platinum-based chemotherapy
Patients must have demonstrated progression on or intolerance to platinum-based chemotherapy
Radiologically confirmed disease progression following two previous lines of anti-cancer therapy, one of which should be a platinum based regimen, OR the patient has refused treatment with approved treatment modalities
Patients either may be treatment-naive and considered ineligible for cisplatin-based chemotherapy or have recurrent disease after any prior platinum-based chemotherapy regimen and meet at least one of the following criteria:\r\n* Glomerular filtration rate ? 30 mL/min and < 60 mL/min (by Cockcroft-Gault)\r\n* Grade 2 or higher hearing loss\r\n* Grade 2 or higher peripheral neuropathy\r\n* Eastern Cooperative Oncology Group (ECOG) performance status 2\r\n* OR have recurrent disease after any prior platinum-based chemotherapy regimen
Tumor progression within 6 months of platinum-based chemotherapy
Have had at least one line of prior platinum-based systemic chemotherapy once diagnosed with recurrence or metastatic disease
Patients must be on treatment with platinum-based (cisplatin, oxaliplatin or carboplatin) treatment for locally advanced or metastatic pancreatic cancer and have received a minimum of 16 weeks of therapy without evidence of disease progression based on the investigator’s opinion\r\n* Discontinuation of the platinum component of the regimen for chemotherapy-related toxicity is permissible provided the patient has previously received at least 16 weeks of platinum-based therapy without evidence of disease progression =< 8 weeks after treatment with the platinum agent
At least 12 months have elapsed since platinum-based peri-operative treatment
Participants must have received 4-6 cycles of platinum-based first-line chemotherapy and must have an ongoing response of complete response (CR), partial response (PR), or stable disease (SD) after completion of chemotherapy; acceptable combinations, as recommended per NCCN guidelines, include cisplatin or carboplatin combined with either etoposide or irinotecan\r\n* As an exception to the above criterion, participants receiving only 3 cycles of chemotherapy due to toxicity are eligible, if they have an ongoing PR or CR after the third (3rd) cycle\r\n* Participants who have received > 6 cycles of platinum-based first-line chemotherapy are not eligible
Participants must initiate study treatment with thoracic radiation therapy =< 8 weeks (56 days) from the last dose of platinum-based first line chemotherapy;\r\n* Thoracic radiation therapy must not be administered < 3 weeks (21 days) from the last dose of platinum-based first line chemotherapy\r\n* Ipilimumab/nivolumab study therapy must not be administered < 13 days and not more than 21 days from the last dose of thoracic radiotherapy
Disease progression on imaging or tumor marker progression (clinical significance of tumor marker progression to be decided per the discretion of treating physician) after at least 2 lines of platinum-based chemotherapies unless patient is ineligible for further platinum based chemotherapy or refuses second (2nd) line platinum based chemotherapy due to toxicity; for primary mediastinal germ cell tumors, failure of first-line chemotherapy will be accepted; prior high dose chemotherapy with hematopoietic stem cell rescue is allowed; prior treatment with bevacizumab is allowed
Patients with prior treatment with platinum-based chemotherapy
Patients must have achieved stable disease, a partial response, or a complete response at their first disease assessment after initiating first-line platinum-based chemotherapy; patients determined to have progressed (in the opinion of the treating physician) at their first disease assessment are not eligible
Subjects who have received at least 1 prior platinum-based therapy. Subjects who have a non-platinum-based regimen may be enrolled with medical monitor approval.
Metastatic or locally advanced and not amenable to curative therapy with disease progression on or after platinum-based chemotherapy or alternative therapy if platinum-based therapy is not appropriate.
Patients who have received only one prior cytotoxic regimen (platinum-based regimen for management of primary disease), must have a platinum-free interval of greater than 6 months
Neoadjuvant platinum-based chemotherapy with recurrence >12 months from completion of therapy is permitted.
Adjuvant platinum-based chemotherapy following radical cystectomy with recurrence >12 months from completion of therapy is permitted.
Patients must be candidates for platinum based chemotherapy and previously untreated
previously received at least 1 but no more than 2 lines of therapy, one therapy must have included a platinum based regimen
Disease Progression between 6-24 months after a first or second platinum based regimen
Must have received prior treatment with a platinum-based therapy
Received first-line treatment with a platinum-based regimen and had no evidence of disease progression for >= 6 months after the last dose
Received second-line treatment with a platinum-based regimen, with progression of disease after attaining a response
Inclusion Criteria:\n\n        Disease status\n\n          -  Parts A and B/B2: Histologically or cytologically confirmed advanced solid tumor that\n             is metastatic or unresectable and for which standard curative or palliative measures\n             do not exist or are no longer effective, or for whom regimens containing gemcitabine,\n             cisplatin, etoposide, and/or irinotecan might be considered, and with measurable\n             disease according to RECIST criteria\n\n          -  Part C1:\n\n        For Pre-screening:\n\n          -  Advanced (metastatic or locally-advanced unresectable and not eligible for definitive\n             treatment, e.g., surgery/radiotherapy), histologically confirmed non-small cell lung\n             cancer (NSCLC)\n\n          -  Available historical tumor specimen at the time of pre-screening or willing to provide\n             a tumor biopsy (core) if the biopsy may be considered as part of standard clinical\n             practice for the participant\n\n          -  Received or did not tolerate standard approved targeted therapy, if appropriate for\n             tumor genotype\n\n        For Screening:\n\n          -  Measurable disease according to RECIST criteria\n\n             -Part C2:\n\n          -  Advanced (locally-advanced incurable or metastatic) histologically confirmed estrogen\n             receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2)\n             negative breast cancer.\n\n          -  Adequate available historical tumor specimen or willing to provide a tumor biopsy\n             (core) if the biopsy may be considered as part of standard clinical practice for the\n             participant\n\n          -  Measurable disease according to RECIST criteria\n\n             -Part C3:\n\n          -  Advanced (locally-advanced incurable or metastatic) histologically confirmed SCLC that\n             is platinum-resistant, defined as disease progression during initial treatment with a\n             platinum-based regimen or progression within 90 days of completion of platinum\n             therapy. Participants with platinum-resistant disease may receive a second-line\n             non-platinum-based chemotherapy and subsequently be enrolled to this study.\n             Participants who received and are resistant to a second-line platinum-based\n             chemotherapy may also be enrolled into the study.\n\n          -  Adequate available historical tumor specimen or willing to provide a tumor biopsy\n             (core) if the biopsy may be considered as part of standard clinical practice for the\n             participant\n\n          -  Measurable disease according to RECIST criteria\n\n          -  WHO performance status of 0 or 1\n\n          -  Life expectancy of >=12 week\n\n          -  Hematological and biochemical indices within protocol specified ranges at screening.\n\n        Exclusion Criteria:\n\n          -  Radiotherapy (except for palliative reasons) endocrine therapy, immunotherapy, or\n             chemotherapy during the previous 4 weeks (6 weeks for nitrosoureas and Mitomycin-C,\n             and 4 weeks for investigational medicinal products) or less than 4 drug half-lives,\n             whichever greater, before first dose of study drug.\n\n          -  Parts A, B and B2:\n\n               -  Greater than 6 cycles of prior treatment with cisplatin and/or carboplatin.\n\n                    1. Part A/B: History of prior dose reductions or dose interruptions while\n                       receiving cisplatin or carboplatin due to toxicity from the platinum or\n                       intolerance to either agent.\n\n                    2. Part B2: Prior exposure to irinotecan is permitted except for participants\n                       with a known hypersensitivity reaction to irinotecan.\n\n               -  Participants with a known history of Grade 4 thrombocytopenia or Grade 4\n                  neutropenia while receiving prior therapy.\n\n          -  Part C1:\n\n               -  Any cytotoxic chemotherapy beyond 1 line of platinum-based chemotherapy. One\n                  additional line of non-platinum based therapy in the advanced setting\n\n                    1. Pre-screening Only*: Participants may currently be receiving platinum-based\n                       chemotherapy in the advanced setting, or have completed 1 line of\n                       platinum-based chemotherapy and are currently receiving a second-line\n                       non-platinum-based therapy or maintenance therapy\n\n                    2. There is no restriction on prior immunotherapy or targeted therapy unless\n                       combined together with a cytotoxic agent\n\n               -  Any prior gemcitabine for the treatment of NSCLC in any setting within 6 months\n\n               -  Participants who are known to be TP53 wild-type, unless they are determined to\n                  have ATM loss of expression during screening or pre-screening or until all the\n                  planned participants with TP53 mutation are enrolled as determined by the medical\n                  monitor\n\n               -  Participants with unknown TP53 mutational status will be enrolled until the group\n                  of approximately 10 participants without TP53 mutation or until all the planned\n                  participants with TP53 mutation are enrolled as determined by the medical monitor\n\n          -  Part C2:\n\n               -  Any prior platinum therapy in the adjuvant or neoadjuvant within 6 months of\n                  screening\n\n               -  Relapse within 3 months of completion of prior adjuvant or neoadjuvant\n                  chemotherapy\n\n               -  Any prior chemotherapy in the metastatic setting with the exception of either a\n                  taxane or an anthracycline in the first-line metastatic setting\n\n                  (a) There is no restriction on prior immunotherapy or targeted therapy in the\n                  metastatic setting unless combined together with a cytotoxic agent\n\n               -  Participants with known BRCA1/BRCA2 germline mutations, either determined and\n                  documented prior to Screening, or determined during Screening. Participants with\n                  unknown BRCA1/BRCA2 status may be enrolled at discretion of the sponsor\n\n               -  Participants who are documented to be non-basaloid subtype using molecular\n                  profiling assay (e.g. PAM50 assay) prior to Screening\n\n               -  Participants with unknown BRCA1/BRCA2 or basaloid subtype status will be enrolled\n                  until the number of enrolled participant is approximately 40. If approximately 40\n                  participants have been enrolled and a minimum of 30 participants who are basaloid\n                  positive and BRCA1/BRCA2 germline wild-type have not been enrolled, the basaloid\n                  subtype and BRCA status assay will be required at Screening to exclude\n                  participants who are basaloid negative or have BRCA1/BRCA2 germline mutations.\n\n          -  Part C3:\n\n               -  Prior platinum-sensitive participants , unless they progress on or within 90 days\n                  of completion of platinum-based regimen\n\n               -  There is no restriction on prior immunotherapy or targeted therapy in the\n                  metastatic setting unless combined together with a cytotoxic agent\n\n               -  During prior carboplatin therapy, requirement for dose reduction below AUC 5\n                  mg.min/mL or discontinuation of carboplatin for toxicity or lack of tolerability.\n\n          -  Unresolved toxicity of Common Terminology Criteria for Adverse Events (CTCAE) Grade 2\n             or greater from previous anti-cancer therapy or radiotherapy\n\n          -  History of spinal cord compression or brain metastases, unless asymptomatic, treated,\n             stable, and not requiring treatment with steroids for at least 4 weeks before first\n             dose of study drug. Any history of leptomeningeal metastases.\n\n          -  Female participants who are already pregnant or lactating, or plan to become pregnant\n             within 6 months of the last dose of study drug are excluded. Female participants of\n             childbearing potential must adhere to contraception guidelines\n\n          -  Male participants with partners of child-bearing potential must agree to adhere to\n             contraception guidelines. Men with pregnant or lactating partners or partners who plan\n             to become pregnant during the study or within 6 months of the last dose of study drug\n             are excluded\n\n          -  Serious cardiac or other co-morbid disease, as specified in the protocol\n\n          -  Prior bone marrow transplant or extensive radiotherapy to greater than 15% of bone\n             marrow\n\n          -  Part C:\n\n               -  Current malignancies of other types, with the exception of adequately treated\n                  cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell\n                  carcinoma of the skin\n\n          -  Major surgery =<2 weeks before starting study drug, or incomplete recovery from a\n             prior major surgical procedure.
Any number of prior lines of systemic therapy may have been received for advanced (recurrent, locally advanced, or metastatic) SCC of the lung, but at least one must have been a platinum-based chemotherapy regimen. Platinum therapy may be given on-label or as part of a clinical trial.
Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease.
Cohort A: Has received 0 to 2 additional prior lines for treating ROC (or 1-3 total prior lines counting the front line) and must have a platinum-free interval (PFI) of ? 3 to 12 months if the last regimen received is a platinum-based, or a treatment-free interval (TFI) of ? 3 to 12 months if the last regimen received is a non-platinum-based
Cohort B: Has received 3 to 5 additional prior lines for treating ROC (or 4-6 total prior lines counting the front line) and must have a PFI of ? 3 months if the last regimen received is a platinum-based, or a TFI of ? 3 months if the last regimen received is a non-platinum-based
Have progressed during or after platinum-based chemotherapy for advanced disease.
Metastatic bladder cancer with disease progression on or after platinum-based chemotherapy
Have progressed after platinum-based chemotherapy (with or without maintenance therapy) AND have received one additional therapy which may include an immune checkpoint inhibitor or other anti-cancer therapy for advanced and/or metastatic disease OR is judged by the physician as ineligible for further standard second-line chemotherapy. Participants who have progressed after platinum-based chemotherapy and an immune checkpoint inhibitor (immunotherapy) e.g. pembrolizumab or nivolumab alone or in combination with other agents are eligible.
Maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate regimen of therapy
Subjects with recurrent disease >6 months after platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a platinum doublet-based regimen given to treat the recurrence are eligible
Received ?2 prior platinum-based treatment regimens including platinum based regimen that must have been administered immediately prior to maintenance therapy in this trial.
Received no more than 1 non-platinum chemotherapy regimen. Prior hormonal therapy will not be counted as a non-platinum regimen.
Must have had at least a 6-month disease-free period following prior treatment with the penultimate platinum-based chemotherapy and achieved a response.
For the last chemotherapy course prior to study entry, patients must have received a platinum-based doublet chemotherapy regimen and have achieved a CR or PR (as defined by RECIST) and/or a GCIG CA-125 response.
Documented relapse or disease progression during or after first-line platinum-based therapy (subjects refractory to initial platinum-based therapy are eligible).
Candidate for re-treatment with original platinum-based regimen as second-line therapy.
At least 3 but no more than 9 weeks between the administration of the last cycle of platinum-based chemotherapy and randomization.
The patient must have received an appropriate platinum-based chemotherapy in the first line setting.
The patient must have demonstrated disease progression following platinum-based chemotherapy.
Participants must have received a first-line platinum-based chemotherapy regimen
Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of limited or extensive disease stage SCLC
Histologically or cytologically confirmed recurrent, metastatic or unresectable HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that that has either progressed during or after platinum-based chemotherapy administered for metastatic disease or has recurred during or within 6 months after the completion of platinum-based neoadjuvant or adjuvant therapy
Received at least 1 platinum-based chemotherapy regimen. Note: Subjects with EGFR mutations or ALK translocations are required to have received prior therapy with appropriate TKI; prior platinum-based chemotherapy is not required for this specific patient population
Documented radiographic disease progression < 12 months after the last dose of first- or second-line platinum-based chemotherapy.
Disease progression or recurrence after both a platinum-based chemotherapy regimen and at least 1 additional regimen for treatment of NSCLC
For platinum sensitive cohort\r\n* Cancer that has not progressed within 6 months of the last receipt of platinum-based chemotherapy\r\n* No limit on the number of platinum-based lines\r\n* No more than one prior non-platinum based line of therapy in the recurrent setting
All patients with ovarian, fallopian tube or primary peritoneal cancer and ovarian carcinosarcoma must have recurrent disease, and only one prior line of chemotherapy that must have been platinum-based chemotherapy for the management of primary disease; this initial platinum-based treatment may have included intraperitoneal therapy, consolidation/maintenance and/or biologic/targeted agents (e.g., bevacizumab, poly adenosine diphosphate [ADP] ribose polymerase [PARP] inhibitor) as part of first-line treatment
Patients with endometrial cancer or endometrial carcinosarcoma may either be chemotherapy naive or have had one prior line of chemotherapy that must have been a platinum-based chemotherapy regimen in the adjuvant or advanced/recurrent setting; the initial platinum-based treatment may have included consolidation/maintenance and/or biologic/targeted agents as part of first-line treatment; patients entering the trial chemotherapy naive must have stage IVB or recurrent disease and have disease that is not amenable to curative intent
Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by independent central imaging review.
At least 14 days since last dose of platinum-based doublet chemotherapy
Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.
Disease progression or recurrence after both a platinum-based chemotherapy and at least 1 additional regimen for treatment of NSCLC
Progression has occurred within 30 days of platinum based chemotherapy consisting of minimum of two cycles of cisplatin-based (?60 mg/m2/cycle) or carboplatin-based (?300 mg/m2/cycle, or area under the time-concentration curve ?4) chemotherapy.
Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin or another organoplatinum compound; patients are also eligible if they received curative intent platinum-based therapy and progressed within a year of therapy
Patients must have received at least one platinum based chemotherapy, and not more than two prior chemotherapy agents and three prior therapies if EGFR or ALK TKI received for EGFR mutation or ALK translocation positive stage IIIB/IV disease\r\n* 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 eligible and the adjuvant or neoadjuvant chemotherapy will count as a line of therapy as above\r\n* Subjects with recurrent disease > 6 months after adjuvant or neoadjuvant platinum-based chemotherapy, who also subsequently progressed during or after a platinum-doublet regimen given to treat the recurrences, are eligible and do not count as another line of therapy for advanced disease\r\n* Subjects who received pemetrexed, bevacizumab, or erlotinib as maintenance therapy (nonprogressors with platinum-based doublet chemotherapy) and subsequently progressed after maintenance therapy are eligible and do not count as a line of therapy; however, subjects who received a tyrosine kinase inhibitor after failure of a prior platinum-based therapy, that tyrosine kinase inhibitor therapy would count as an additional line of therapy
Patient must have received a platinum based chemotherapy regimen (e.g. carboplatin or cisplatin) and have received at least 4 cycles of treatment
Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease
Have been treated one time with a platinum-based chemotherapy and your disease has come back at least six months after you completed treatment
At least one prior line of platinum-based chemotherapy or patient must have refused cytotoxic chemotherapy; progressive disease must be documented prior to study entry
Progressive or recurrent disease occurring\r\n* During or after treatment with a platinum containing regimen (cisplatin or carboplatin or novel platinum) in either in the metastatic or perioperative setting\r\n* In first-line patients defined as platinum ineligible based on renal impairment (creatinine clearance calculated by Cockcroft-Gault method < 60 ml/min), grade 2 hearing loss and/or Eastern Cooperative Oncology Group (ECOG) status of 2; these patients will be chemotherapy naive or have received platinum based therapy in the adjuvant or neoadjuvant setting more than 12 months prior to study entry
Subjects must have received at least 1 prior platinum-based line of chemotherapy for ovarian cancer. Note: There is no limit on the number of lines of chemotherapy;
Prior systemic regimens must include at least 2 cycles of a platinum-based therapy and may include platinum therapy used as a radiosensitizer. Maintenance chemotherapy is allowed.
Subjects are eligible after first line platinum based chemotherapy if their disease has relapsed and they have primary mediastinal non seminomatous germ cell tumor (PMNSGCT) or late relapse (> 2 years) not amenable to surgical resection
Recurrent or progressive disease after one prior platinum-based non-pemetrexed chemotherapy treatment for advanced disease with or without maintenance
Participants must have progressed on one prior line of platinum-based chemotherapy in the advanced or metastatic setting.
Participants who received prior therapy with paclitaxel as a part of the platinum-based doublet front-line regimen without PD on therapy.
Patients who have received only one prior cytotoxic regimen (platinum based regimen for management of primary disease), must have a platinum-free interval of 6 to 12 months; patients who have progressed during platinum-based therapy or have persistent disease after a platinum-based therapy are excluded
Patients who have progressed during initial platinum-based therapy in the upfront setting, who have persistent disease after this initial platinum-based therapy, or who have recurrence less than 6 months from adjuvant chemotherapy are excluded
Histologically confirmed, adenocarcinoma of the lung, after failure of first line platinum-based chemotherapy.
Treatment naive OR one prior standard chemotherapy that is platinum-based
Patients must have histologically confirmed recurrent or metastatic gastrointestinal carcinomas, non-squamous non-small cell lung carcinomas, urothelial carcinomas, and sarcomas with disease progression after at least one line of standard therapy; disease should have progressed following all treatments known to prolong survival, unless a given treatment is contraindicated\r\n* Patients with colorectal carcinoma must have progressed through at least two lines of standard chemotherapy in the metastatic setting\r\n* Patients with non-small cell lung cancer with known sensitizing EGFR mutation and/or anaplastic lymphoma kinase (ALK) rearrangement should have received prior erlotinib and/or crizotinib, respectively\r\n* Patients with urothelial carcinoma will have progressed on prior platinum-based therapy or for which platinum-based therapy is contraindicated\r\n* Patients enrolled on the expansion phase of the protocol must demonstrate EGFR expression by immunohistochemistry on archival tumor samples prior to undergoing 89Zr-panitumumab PET/CT scans
Maintenance therapy for patients after completion of four cycles of dual-agent platinum-based chemotherapy
Eligibility for platinum-based chemotherapy
Patients with recurrent or metastatic disease resistant to platinum-based chemotherapy (defined as progression while on platinum-based chemotherapy given in the recurrent/metastatic setting). Pretreatment with cetuximab is allowed
Patients must be resistant to platinum-based chemotherapy, or be ineligible (due to medical comorbidities) or intolerant to platinum-based therapy per medical history
Prior therapy with an anti-HER2 agent and/or platinum-based chemotherapeutic agent
Recurrent or progressive disease on or after initial platinum-based chemotherapy
Progression or relapse from prior platinum-based chemotherapy must be documented radiographically by RECISTv1.1 criteria For ovarian cancer dose expansion cohorts only:
Primary refractory disease (progressive disease on initial platinum based chemotherapy) or chemotherapy-resistant disease (disease progression within 90 days of completion of initial chemotherapy)
Previously treated with one platinum-based chemotherapy
Eligible patients are those with documented disease recurrence/progression within 0-12 months of completing platinum-based chemotherapy
Prior chemotherapy that included a platinum agent
For ovarian cancer participants only, platinum-based chemotherapy within 6 months prior to Day 1.
Received a minimum of one course of treatment that included at least one platinum-based chemotherapy doublet for metastatic or locally recurrent disease.
For Part 3, subject has ovarian cancer that was previously treated with platinum based chemotherapy resulting in progression free survival for < 6 months from the completion of treatment.
Progression during or after platinum-based therapy for recurrent or metastatic ESCC, or recurrence within 6 months of platinum-based chemotherapy or chemoradiotherapy for localized disease.
Prior treatment with crizotinib and progression according to RECIST v1.1 criteria with the last dose of crizotinib within 60 days from enrolment; patients can either be chemotherapy-naïve or have received at least one line of platinum-based chemotherapy
Patients must have had one prior platinum-based chemotherapy regimen for management of primary disease
Patients who have received only one prior cytotoxic regimen (platinum-based regimen for management of primary disease), must have a platinum-free interval of less than 12 months, or have progressed during platinum-based therapy, or have persistent disease after a platinum-based therapy
Patients must have completed front-line, platinum-based chemotherapy with CR, PR, or NED and have first study treatment dose within 12 weeks of the first day of the last cycle of chemotherapy:
A platinum-based regimen must have consisted of a minimum of 6 and a maximum of 9 treatment cycles. Patients who discontinued platinum-based therapy early as a result of non hematologic toxicity specifically related to the platinum regimen (ie, neurotoxicity or hypersensitivity) are eligible if they have received a minimum of 4 cycles of the platinum regimen.
IV, intraperitoneal, or neoadjuvant platinum-based chemotherapy is allowed; for weekly therapy, 3 weeks is considered 1 cycle. Interval debulking is allowed.
Patients must have received, prior to enrollment, a minimum of 3 cycles of bevacizumab in combination with the last 3 cycles of platinum-based chemotherapy. Patients who undergo interval debulking surgery are eligible if they have received only 2 cycles of bevacizumab in combination with the last 3 cycles of platinum-based chemotherapy.
Progressive disease on or after first-line platinum-based chemotherapy regimen for R/M SCCHN (maximum of 6 cycles)
No more than one platinum-based chemotherapy regimen for R/M SCCHN is allowed
Prior platinum-based treatment as definitive chemo/radiotherapy for locally advanced disease is allowed if completed/terminated >/= 6 months before the platinum-based regimen for R/M SCCHN
Prior treatment with at least one platinum-based line of treatment (for stage IIIb/IV) and no more than one additional line of chemotherapy treatment; the last dose of chemotherapy must have been administered >/= 21 days prior to Day 1
Any other than one previous platinum based systemic regimen given for R/M disease
must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug
Patients must have experienced progressive disease following at least one platinum-based chemotherapy regimen in the setting of advanced disease or have progressed within 6 months of receiving chemotherapy as part of loco-regional therapy
Initiation of first-line chemotherapy with a platinum-pemetrexed-based regimen within 14 days of registration or planning to initiate within 14 days after registration; no planned initiation of definitive (potentially curative) concurrent chemo-radiation
There is no upper limit of prior therapies but patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; any platinum based chemotherapy (single agent platinum or any platinum doublet) administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen; furthermore, patients who have only received chemotherapy in the adjuvant setting will be eligible for the study
Have ED-SCLC and have received a prior platinum-based regimen
Have received one or more of the following chemotherapy (CTX) drugs: taxanes or platinum compounds
Patient must have completed 4-6 cycles of platinum-based chemotherapy (+/- thoracic radiotherapy)
Patients who are planned to receive definitive or adjuvant radiotherapy with concurrent platinum-based chemotherapy
Metastatic or advanced endometrial carcinoma previously treated with at least 1 platinum-based chemotherapeutic regimen.
Suitable to receive a platinum-based chemotherapy regimen as 1st line treatment.
Patients can either be chemotherapy-naive or have received at least one line of platinum-based chemotherapy for locally advanced or metastatic disease; acute effects of therapy must have resolved to baseline severity or to CTCAE grade =< 1 except for AEs that in the investigator’s judgment do not constitute a safety risk for the patient
Have pathologically proven ovarian cancer or cancer of mullerian origin that requires first-line treatment with a taxane + platinum based chemotherapy regimen
Has received systemic chemotherapy for ovarian cancer or cancer of mullerian origin other than first-line treatment with a taxane + platinum based chemotherapy regimen
Scheduled to receive front-line platinum-based chemotherapy with carboplatin or cisplatin plus etoposide
Received debulking surgery and preoperative and/or postoperative platinum-based frontline chemotherapy (intravenous and/or intraperitoneal) for the treatment of EOC/FTC/PPC.
PD during or following at least 1 prior treatment. Participants should have received a prior platinum-based 2-drug regimen for locally advanced, unresectable/ inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen or combined modality (example, chemoradiation) regimen with curative intent.
Considered to be eligible to receive platinum-based chemotherapy, in the investigator's judgment
Part B: must have received at least 1 prior therapy containing platinum-based chemotherapy for advanced/metastatic NSCLC
Patients who have had prior platinum-based therapy who have > grade 1 neurotoxicity or ototoxicity at the time of enrollment will not be permitted on study
Progression after platinum-based chemotherapy
Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor
Eligible for CHOP regimen
At least 1 prior chemotherapy regimen
All participants must be prescribed combination antiretroviral therapy with the goal of virological suppression using an acceptable regimen that adheres to national guidelines for treatment of HIV infection; non-suppressed, treatment experienced patients, defined as patients with a viral load > 400 copies/mL who have been on antiretroviral therapy for more than 4 months can be enrolled if an alternative antiretroviral therapy (ART) regimen is available that includes at least two ART drugs that, in the opinion of the site investigator, are expected to have activity based on genotypic testing (if available) and treatment history; patients are not allowed to receive zidovudine (azidothymidine [AZT]) as part of concurrent chemotherapy and ART regimen, since it is myelosuppressive; zidovudine may be discontinued and substituted as clinically indicated prior to or at the time of enrollment
Patients may not have progressed on more than two chemotherapy regimens in the metastatic setting; the following will NOT be counted as a prior line of cytotoxic chemotherapy:\r\n* If a patient discontinued a cytotoxic regimen due to toxicity (e.g., hypersensitivity or neuropathy) but had not progressed on that regimen, or if a prior chemotherapy regimen was discontinued after response achieved, it will not be counted in the number of prior chemotherapy regimens allowed\r\n* Prior hormonal therapy and non-hormonal targeted therapy; including the combination of an aromatase inhibitor and everolimus\r\n* Targeted and biologic therapies\r\n* The patient can receive a stable dose of bisphosphonates or denosumab for bone metastases, before and during the study as long as this was started at least 5 days prior to study treatment
Patients with histologically confirmed advanced solid tumors (regimen A) or breast or pancreas (regimen B)
Patients who have already started or received post-transplant maintenance or consolidation regimen
a) Active Disease (1) Clinically suspected or documented relapse/progression, in first or second relapse following at least one cycle of an asparaginase-based chemotherapy regimen OR (2) Initial disease or first or second relapse and unable to tolerate one full cycle of asparaginase-based chemotherapy regimen OR b) High-risk disease (stage III/IV, KPI groups 3-4 or IPI intermediate-high) prior to second CR regardless of previous chemotherapy.
Patients must have failed a carboplatin-based regimen
Patients with exocrine pancreatic adenocarcinoma must have predominant adenocarcinoma histology. Patients must have received prior therapy with a gemcitabine-based or 5FU-based regimen, if eligible, and should have received no more than 1 systemic regimen in the unresectable or metastatic setting.
Ability to be off prednisone and other immunosuppressive drugs for at least 3 days prior to the NK cell infusion (excluding preparative regimen pre-meds)
Part 2, Cohort 2, Must have received ? 1 prior treatment regimen for ovarian cancer, at least 1 of which is a platinum-based regimen
Patients may have received 0-1 prior chemotherapeutic regimen for metastatic breast cancer and must have been off treatment with chemotherapy for at least 21 days before enrollment in the study; the number of patients with 0 prior chemotherapeutic regimen will be limited to a maximum of n = 20
Patients must have received at least one cycle of the cytotoxic chemotherapy regimens (or regimen of similar intensity) listed in Appendix D within 3 months of enrollment (measured from the start date of chemotherapy) OR have had an autologous transplant within 24 months of enrollment OR receive 300 cGy as part of the preparative regimen
Must have previously received and progressed on at least 1 prior chemotherapy regimen.
Prior regimen within 6 months
The patient should have received all established therapies where there is a clear, superior available regimen available for the patient and the patient should have demonstrated progressive disease on or since completion of the last treatment regimen
Prior regimen must be within 6 months of registration
Patients may be treatment-naive or have failed previous regimen of intravesical therapy
Prior therapy:\r\n* Patients may have received unlimited prior treatment for the dose escalation part\r\n* For the expansion cohort patients must have ? 4 prior lines of chemotherapy\r\n* Hormonal therapy does not count towards total lines of therapy\r\n* Maintenance therapy is considered part of the preceding regimen if one or more of the same drugs are continued\r\n* Neoadjuvant and adjuvant chemotherapy are considered one regimen if they are a continuation of the same regimen with interval debulking surgery
Patients may not have received more than 3 prior regimens, where the regimen intent was to induce remission
Subjects must have relapsed or refractory non-Hodgkin lymphoma treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve partial or complete remission with the last regimen.
No limit to the number of prior chemotherapy or endocrine therapy regimens received; use of a previous fluoropyrimidine-containing regimen in advanced/metastatic setting is permitted as long as the subject discontinued the regimen for reasons other than progression
Patient has used capecitabine in a past regimen for metastatic disease
For Dose Escalation, NSCLC and Ovarian Expansion Cohorts: Subject must have failed at least one prior chemotherapy regimen for metastatic disease (urothelial and bladder cancer subjects are not required to have failed prior chemotherapy regimen if considered unfit for cisplatin-based chemotherapy)
Patients who have failed bendamustine-based regimen previously
Patients must be considered candidates for intensive chemotherapy treatment with standard doses of cytarabine and anthracycline regimen (“7+3 regimen”)
Have relapsed or refractory disease after at least 1 prior regimen, including: \r\n* Recurrence of disease after a documented complete response (CR) \r\n* Progression of disease after a partial response (PR) to the prior regimen \r\n* Partial response (PR), stable disease (SD) or progressive disease (PD) at the completion of the prior treatment regimen; if a patient has PR to prior regimen without PD, there must be biopsy-proven residual disease that is measurable
For advanced (stage III/IV) Hodgkin disease, patients must have failed an Adriamycin containing regimen (adriamycin-bleomycin-vinblastine-dacarbazine [ABVD]) or an alternative non-cross resistant regimen (e.g. mustargen-oncovin-procarbazine-prednisone [MOPP])
DONOR: Is approved and completed evaluation prior to recipient initiation of the preparative regimen per institutional guidelines
Prior treatment with (or intolerance to) at least one standard systemic regimen for the patient's respective tumor
There will be no limit to number of prior myelosuppressive regimen for GIST or other tumor manifestations associated with NF1
Has evidence of progression on or after the last regimen received:
Patients underwent >= 1 prior chemotherapy-based or immunotherapy-based regimen or targeted therapy (e.g., inhibitors of BTK, PI3K etc.) administered for >= 2 cycles, and have had either documented disease progression or no response (stable disease) to the most recent treatment regimen
Patient must have prior treatment with a platinum plus pemetrexed regimen
More than one systemic therapy regimen of any type for metastatic or locally advanced disease; adjuvant gemcitabine that ended more than 6 months prior to diagnosis of recurrent disease is not considered as a regimen
Incurable cervical or anal cancer, as defined by:\r\n* Relapsed or progressive disease at the primary site and/or regional lymph nodes after initial treatment (e.g. systemic chemotherapy) with no potentially curative option (i.e. surgery or chemoradiotherapy); chemotherapy administered in conjunction with primary radiation as a radiosensitizer will not be counted as a systemic chemotherapy regimen; OR\r\n* Distant metastasis refractory to initial treatment (at least one prior chemotherapeutic regimen which can include a single chemotherapeutic, a combination of chemotherapeutics, or biologic drugs); cervical cancer subjects with distant metastases will have received and failed bevacizumab prior to enrollment onto the trial
Treatment with other chemotherapy regimen within the past 2 weeks
Participants must have received at least one prior chemotherapy regimen for their disease
Concurrent systemic high-dose corticosteroids when used intermittently in an antiemetic regimen, for central nervous system (CNS) metastases management, or as a part of the premedication regimen are allowed
Left ventricular ejection fraction of at least 40% (myeloablative regimen 1, reduced intensity regimen 3)
Pulmonary function test (PFT) demonstrating an adjusted diffusion capacity of least 50% predicted value for hemoglobin concentration (myeloablative regimen 1, reduced intensity regimen 3)
Serum glutamate pyruvate transaminase (SGPT)/bilirubin < to 2.0 x normal (myeloablative regimen 1), reduced intensity regimen 3; SGPT/bilirubin < to 4.0 x normal (nonmyeloablative regimen 2)
Patients must have received at least 1 prior regimen
Failed at least 1 prior chemotherapy regimen for advanced NSCLC
Any other condition that, according to the investigator, may forbid the administration of the idarubicin + cytarabine regimen
Patients who have received more than 1 prior therapy; NOTE: Prior therapy is defined as any single agent or combination regimen that is included as treatment for symptomatic CLL; treatment(s) given prior to the symptomatic phase of the disease (preventive strategy) will not be considered as prior induction therapy; for the purpose of a particular therapy/regimen to be counted towards the number of prior treatments a patient must have received at least 2 cycles of the induction regimen e.g., a patient who change their treatment regimen after only 1 cycle (due to toxicity or any other reason) will not be considered to have \2\ prior therapies
Concurrent systemic high-dose corticosteroids when used intermittently in an antiemetic regimen for central nervous system (CNS) metastases management or as a part of the premedication regimen are allowed
Patients may not have received more than 3 prior regimens, where the regimen intent was to induce remission
Phase II: patients are eligible if their previous chemotherapy regimen did not contain bortezomib, carfilzomib, or other known proteasome inhibitor or a combination of gemcitabine >= 800 mg/m^2 plus adriamycin >= 30 mg/m^2; patients who receive sequential or alternating therapy as part of front-line treatment will be counted as having one prior regimen; patients who have failed prior neoadjuvant chemotherapy will be eligible for this trial
Patients who have already started or received multi-drug consolidation regimen post-transplant expect for patients receiving up to 4 months of single agent  lenalidomide maintenance
Prolymphocytic leukemia (PLL) T-cell (T)-CLL\r\n* T-PLL: treatment failure after Campath-1H and at least one other regimen\r\n* B-PLL: treatment failure after fludarabine and at least one other salvage regimen
Burkitt or lymphoblastic lymphomas\r\n* High-risk disease in remission\r\n* Progression after >= 1 previous regimen\r\n* Non-CR after salvage regimen
Able to initiate study treatment no later than 6 weeks from last dose of any antineoplastic component of prior therapy regimen
Patients must be ineligible for, refused or having failed at least one previous salvage regimen
Participants for the phase 2 portion of the study must, in addition, meet the following: o Must be refractory to or relapsed after no more than 2 prior chemotherapy regimens. Re-induction with the same regimen or stem cell transplant will not be considered a separate regimen.
Cardiac disease (history of and/or active disease) that would preclude the use of any of the drugs included in the treatment regimen. This includes but is not confined to:
More than one prior systemic therapy regimen for metastatic pancreatic cancer (radiosensitizing doses of 5-FU or gemcitabine at the time of initial radiotherapy do not count as a prior systemic therapy regimen)
Patients with more than one prior chemotherapy regimen for management of primary disease
Detectable tumor prior to mobilization regimen
Have received at least one prior chemotherapy regimen for SCLC
Has had prior therapy with more than one cytotoxic chemotherapy regimen NOTE: Treatment with maintenance therapy after initial chemotherapy will not be considered a separate regimen and will be allowed.
Participants must be considered by their physician eligible to receiving the IRD regimen.
Previously treated with not more than 1 doublet or triplet regimen and that regimen contained gemcitabine and a platinum agent
Patients who have been treated with more than one chemotherapy regimen, immunotherapy regimen or chemotherapy/immunotherapy regimen for metastatic non-small cell lung cancer
Received at least one prior treatment regimen;historically documented CD20-positivity is acceptable;
Patients with MCL underwent >= 1 chemoimmunotherapy-based regimen; patients with FL and MZL underwent >= 1 prior chemotherapy-based and/or immunotherapy-based regimen; patients with DLBCL and CLL in Richter’s transformation underwent >= 1 chemoimmunotherapy-based regimen and are not transplant-eligible; patients with CLL, B-PLL and LPL underwent >= 1 chemotherapy-based, or immunotherapy-based or targeted therapy regimen (e.g., PI3K inhibitors [idelalisib], venetoclax, ibrutinib or an investigational agent, including an investigational BTK inhibitor); all regimens must have been administered for >= 2 cycles, and patients must have had either documented disease progression or no response (stable disease) to the most recent treatment regimen
High dose TBI regimen: 18 to =< 45 years
Intermediate intensity regimen: 18 =< 65 years
The regimen under study must constitute a reasonable therapeutic option
No more than one prior chemotherapy regimen for advanced or metastatic breast cancer is allowed; prior chemotherapy for metastatic disease must have been completed >= 14 days prior to randomization\r\n* Any single agent therapy, and any combination of cytotoxic, endocrine, biological targeted agents, and/or humanized antibodies, scheduled to be administered as a preplanned treatment, given concomitantly, sequentially or both, is considered one regimen\r\n* Planned neoadjuvant chemotherapy and postoperative adjuvant chemotherapy is considered one regimen\r\n* If the dosing of one or more of the chemotherapy components of a regimen must be reduced for toxicity, the modified version of the original regimen is not considered a new regimen\r\n* If one or more of the chemotherapy components of a regimen must be omitted for toxicity, the modified version of the original regimen is not considered a new regimen\r\n* If one of the chemotherapy components of a regimen must be replaced with another similar drug of the same therapeutic class, the modified version of the original regimen is not considered a new regimen; however, if a new component, dissimilar to any of the original components, is added to the regimen, the modified version is considered a new regimen\r\n* If chemotherapy is interrupted for surgery or radiotherapy and then continues with an unchanged schedule and components, treatment is considered as one regimen despite the interruption
HIV seropositive participants must be on antiretroviral therapy (ART) with the following criteria:\r\n* A complete ART regimen that does not include the study drug as one of a minimum of 3 active drugs, which may include an integrase inhibitor or efavirenz in combination with nucleoside reverse-transcriptase inhibitors (NRTIs)\r\n* The ART regimen must not include protease inhibitor (PIs); participants must not have received a PI-based regimen for at least 4 weeks prior to enrollment\r\n* Participants must either have an undetectable HIV plasma ribonucleic acid (RNA), or if plasma RNA detectable, must be on the same stable regimen for a minimum of 12 weeks prior to study enrollment\r\n* No minimum cluster of differentiation (CD)4 count, but maximum HIV plasma RNA of 1,000 copies/mL
Participant has received more than one prior systemic therapy regimen for SCLC.
Patients must have been pretreated for advanced disease - the number of prior systemic therapy/regimen depends on which origin for NET and for GEP-NEC
Patients must have received < 3 lines of prior therapy and have relapsed less than a year from their last platinum regimen; regimens that are used twice (for example carboplatin and paclitaxel) can be counted as one; if a regimen is changed during the course of treatment due to side effect profile or allergy, the course of therapy is counted as one regimen; (for example, if docetaxel is substituted for paclitaxel due to a reaction during the initial course of adjuvant therapy, this is considered one regimen)
More than 2 prior chemotherapy regimens for the current malignancy; full dose chemotherapy used in conjunction with concurrent radiation therapy will be included as prior therapy\r\n* Note: Prior hormonal therapy (e.g. leuprolide, aromatase inhibitors, tamoxifen) and immunotherapy will be allowed and not included as a prior chemotherapy; if the chemotherapy regimen is altered during the course due to issues with tolerability or safety, the regimen will be counted as one; using the same regimen at recurrence is counted as one regimen; the addition of bevacizumab to a prior regimen is considered one regimen
Stable, continuous antiretroviral treatment for at least three months before enrollment, defined as a multi-drug regimen (excluding azidothymidine [AZT])
At least 14 days must lapse between last prior anti-cancer treatment and 1st day of preparative regimen
All treatment regimens must have been administered for ?2 cycles unless patient is immediately allergic or intolerant to the regimen
Disease specific therapies within 1 week of starting conditioning regimen
Patients 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 concurrent with primary radiation (e.g.; weekly cisplatin) is not counted as a systemic chemotherapy regimen; adjuvant chemotherapy given following the completion of radiation therapy (or concurrent chemotherapy and radiation therapy) is not counted as a systemic chemotherapy regimen (e.g.; paclitaxel and carboplatin for up to 4 cycles); NOTE: patients who have received more than one prior regimen are NOT eligible
Patients must have received at least one prior regimen of chemotherapy for symptomatic multiple myeloma; patients may not have more than six (6) previous regimens of therapy for the disease; prior chemotherapy must have been completed at least 21 days prior to registration; for study purposes, a regimen is defined as follows:\r\n* An anti-myeloma therapy used at the time of initial diagnosis or documented disease progression which is given with the intent to decrease disease burden\r\n* Any maintenance therapy used after an Induction should be considered part of that Induction regimen\r\n* Use of any agent or combination of agents more than once during the patient’s disease history for separate documented disease progressions will be counted as separate regimens (e.g., if a patient receives lenalidomide/bortezomib at initial diagnosis and achieves response, but then progresses and receives lenalidomide/bortezomib after progression, these count as 2 separate regimens)\r\n* In cases of allogeneic or autologous stem cell transplant, the entire induction + stem cell mobilization + conditioning + planned maintenance should be considered one regimen
Patients who have relapsed from their initial doxorubicin, bleomycin, vinblastine and dacarbazine (ABVD) or similar standard treatment regimen and have not received any other chemotherapy or salvage systemic treatment
Participants on an antiretroviral regimen should be receiving treatment that is in accordance with the current International acquired immune deficiency syndrome (AIDS) Society guidelines; the specific agents are at the discretion of the investigator and use of agents currently available on an expanded access basis is allowed but use of experimental antiretroviral agents or those containing zidovudine (including Combivir and Trizivir) are prohibited; changes to highly active anti-retroviral therapy (HAART) therapy may be made if medically necessary (toxicity, failure of regimen, etc.); antiretroviral naïve participants: participants who are not on HAART at study entry MUST begin therapy (utilizing the above guidelines) AFTER one cycle of chemotherapy has been completed under protocol; changes to HAART therapy may be made if medically necessary (toxicity, failure of regimen, etc.); concurrent therapy with zidovudine or a zidovudine-containing regimen (including Combivir and Trizivir) will be prohibited until 2 months following the participant’s completion of chemotherapy as part of this protocol; the use of cobicistat (e.g., Tybost), or cobicistat containing single tablet regimens (e.g., Stribild) is prohibited during concurrent chemotherapy under this protocol; participants taking cobicistat or cobicistat-containing single table regimens must switch to a different agent or regimen prior to enrollment, and will remain on the regimen until at least 2 months following treatment discontinuation; Cobicistat is a pure and potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitor and has the potential to increase the area under the curve (AUC) of CYP3A4 substrates; therefore, both vincristine and doxorubicin would have the potential for drug drug interaction (DDI) with cobicistat since they are CYP3A4 substrates
For advanced (stage III/IV) Hodgkin's disease, patients must have failed an adriamycin containing regimen (ABVD) or an alternative non-cross resistant regimen (e.g. MOPP)
Patients who have received more than one previous regimen of chemotherapy (maintenance is not considered a second regimen)
Must have received > or = 1 prior treatment regimen.
If the subject has DLBCL, there is no curative option with conventional therapy and the prior treatment included ? 1 prior combination chemoimmunotherapy regimen.
Must have achieved at least a minimal response (MR) to at least 1 prior anti-myeloma regimen before developing PD (relapsed)
A prior line of treatment is considered an induction regimen if it involves an approved or investigational cytotoxic chemotherapy agent, biological agent, and/or hypomethylating agent administered alone or in a combination regimen, with the intent to induce robust cytoreduction (i.e., CR).
A prior line of treatment is considered an induction regimen if it involves an approved or investigational cytotoxic chemotherapy agent, biological agent, and/or hypomethylating agent administered alone or in a combination regimen, with the intent to induce robust cytoreduction (i.e., CR).
Must be eligible to receive second-line standard-of-care chemotherapy with either 1) an oxaliplatin-based chemotherapy regimen, or 2) an irinotecan-based chemotherapy regimen
All patients must have received at least one prior therapy - 1 cycle of cytarabine containing regimen or 2 cycles of hypomethylating agent - before determination of refractory status (defined as response duration less than 3 months or no response)
Patients must have received as a minimum a first line chemotherapy regimen consisting of at least 2 of the following agents: doxorubicin, cyclophosphamide, ifosfamide, etoposide.
Patients must have had one and only one prior regimen of systemic therapy for metastatic disease unless the patient meets the criteria below
Previous single agent exposure to the selected chemotherapy regimen for randomisation.
More than one chemotherapeutic regimen given for R/M disease. Prior treatment with immunotherapy is allowed.
Carmustine ? 600 mg/m² received as part of the pre-transplant conditioning regimen
The subject has received at least 1 line of therapy in the metastatic or locally advanced disease setting. The subject has been documented to have progressed by determination of the investigator on a regimen containing an anti-HER2 agent as the most recent regimen or the most recent anti-HER2 regimen was discontinued for any toxicity, with the exception of a cardiotoxicity.
Patients must have relapsed after having achieved at least stable disease for at least one cycle of treatment to at least one prior regimen and then developed PD.
Patients must also have documented evidence of PD during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry (refractory disease).
Group A at least one prior regimen of therapy
Tumor relapse/progression within 6 months of completion of a cisplatin-based chemoradiotherapy regimen for the treatment of early stage tumors
Participants requiring anti-diabetic medications must be on a stable dose and regimen for >=4 weeks
Experimental therapies when given as separate regimen are considered as separate line of therapy
For patients with relapsed/refractory disease: patients may have previously received chemotherapy with a mitoxantrone- or cladribine-based regimen for MDS or AML; if that patient has received G-CLAM before and has been sensitive to this regimen, eligibility will be determined on a case-by-case basis by the study principal investigator (PI)
Subject must have received ? 1 prior treatment regimen(s)
Required drainage of ascites during the final 2 cycles of their last platinum-based regimen and/or during the period between the last dose of chemotherapy of that regimen and randomization to maintenance treatment in this study.
During the study period, subjects using hormonal therapy and bisphosphonates should maintain a constant dose and should not change existing regimen.
Receive only RIC regimen (i.e. Regimen A)
Patients must have had prior systemically administered platinum-based chemotherapy; pleural space washing with cisplatin does not constitute systemic administration; no more than two prior systemic therapeutic regimens are allowed (including biologics, targeted therapies), and at least one regimen must have been platinum-based; immunotherapy will not be counted as a prior regimen; neoadjuvant and/or adjuvant systemic therapy will not be counted as a prior regimen, assuming at least 12 weeks have elapsed between the end of neoadjuvant/adjuvant therapy and development of progressive disease; patients must have completed systemic therapy (including any chemotherapy, biologics, targeted and immunotherapies) >= 28 days (42 days for nitrosoureas or mitomycin C) prior to registration and have recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered
Participants must have received at least one prior platinum-based regimen for advanced cholangiocarcinoma and had progressive disease or become intolerable to the regimen
Patients must have received at least one prior systemic chemotherapy regimen for metastatic pancreatic cancer; they should have experienced disease progression or intolerable toxicity from that regimen
Use of a systemic treatment regimen for metastatic disease within 28 days preceding the first dose of AEB071 and BYL719
Patients who have received no more than 1 prior cytotoxic treatment regimen.
If receiving myelofibrosis therapy, must be on a stable dose of the same regimen for at least 2 weeks prior to screen date and through the screening period
Documented relapse or progressive disease on or after any regimen (subjects refractory to the most recent regimen are eligible)
Patients who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participation
Not appropriate for treatment with a purine-based analogue regimen (per National Comprehensive Cancer Network [NCCN] or European Society for Medical Oncology [ESMO] guidelines), including relapse ? 36 months from a purine-based chemoimmunotherapy regimen or relapse ? 24 months from a purine-based monotherapy regimen
Patients must have prior treatment with >= 2 cycles of lenalidomide and >= 2 cycles of bortezomib (either in separate regimens or as part of the same regimen) (primary refractory of subjects refractory to the most recent regimen are eligible)
Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study.
Must have received at least 1 prior platinum-based chemotherapy regimen but have received no more than 3 lines of prior chemotherapy regimens, with no limit to the number of lines of prior hormonal therapy. Front-line therapy may include neoadjuvant and adjuvant therapy and will be counted as 1 prior systemic regimen. Biological therapy (e.g. bevacizumab) administered as a single agent is considered a prior systemic regimen and not a prior chemotherapy regimen. Maintenance therapy is not considered its own regimen but should be included with the regimen that it follows.
Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
At least 2 prior chemotherapy regimens; at least one fludarabine or other nucleoside analog containing regimen; chemotherapy in combination with monoclonal antibody (Rituxan) will be considered one prior regimen, but single agent Rituxan will not be considered one prior regimen; single agent ofatumumab will be counted as a regimen
Age criteria:\r\n* High dose TBI regimen: 6 months to =< 45 years \r\n* Middle intensity TBI regimen: 6 months to =< 65 years\r\n* Conditioning regimen selection should be based on the underlying disease, presence of minimal residual disease (MRD), age, co-morbidities, attending physician, and site preference; conditioning regimen will not require stratification of the randomization due to heterogeneity in the cohort of eligible patients.
Relapsed after ? 2 prior chemotherapy regimens, including the following: First-line treatment with standard anthracycline-containing regimen (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone or equivalent). At least 1 additional combination chemotherapy regimen. Patients relapsed after or refractory to first prior chemotherapy- and/or immunotherapy-based regimen for aggressive NHL and not eligible for high-dose regimen followed by transplant. High-dose chemotherapy, or chemoradiotherapy with autologous stem cell transplantation is considered 1 regimen. Patients with CD20 expressing neoplastic cells must have received prior rituximab, if available.
Patients with primary AML should have received no more than two (2) prior cytotoxic containing salvage regimens. Reinduction with the same regimen or stem cell transplant will not be considered a separate salvage regimen. Change of drugs will be considered a salvage regimen. Unlimited FLT3 TKI therapy (even in combination with cytotoxics/hypomethylating agents) is allowed for patients enrolled in cohort B
For patients with HL or ALCL, subjects are eligible after failure of at least one prior multi-agent chemotherapy regimen
Patients previously treated with a bendamustine-containing regimen who did not achieve a response or who relapsed and required treatment within 24 months of treatment with that regimen
Subject had no response (i.e., stable disease only) to first-line therapy with R-Cyclophosphamide, Hydroxydaunomycin, Vincristine (Oncovin), Prednisone (R-CHOP) or an equivalent regimen;
Patients must have received at least one chemotherapy regimen which contained doxorubicin.
Subjects must have failed at least one previous chemotherapy regimen for metastatic disease if standard therapies exist
Patients who provide consent for placement of the IP port system, if randomized to Regimen II (Study treatment: dd-TCip therapy)
Patients had at least one prior regimen consisting of at least 1 cycle
Patients with AML and ALL should have received at least 1 prior treatment regimen and either failed to achieve response or relapsed on treatment
Patients with more than one previous chemotherapy regimen
Chronic lymphocytic leukemia (CLL) must have either \r\n * 1) Failed to meet National Cancer Institute (NCI) Working Group criteria for complete or partial response after therapy with a regimen containing FLU (fludarabine phosphate) (or another nucleoside analog, e.g. 2-chlorodeoxyadenosine [2-CDA], pentostatin) or experience disease relapse within 12 months after completing therapy with a regimen containing FLU (or another nucleoside analog) \r\n * 2) Failed FLU- CY (cyclophosphamide)-rituximab (FCR) combination chemotherapy at any time point; or \r\n * 3) Have \17p deletion\ cytogenetic abnormality and relapsed at any time point after any initial chemotherapy
Prolymphocytic leukemia (PLL), T-cell chronic lymphocytic lymphoma (T-CLL)\r\n* T-PLL: treatment failure after Campath-1H and at least one other regimen\r\n* B-PLL: treatment failure after fludarabine and at least one other salvage regimen
Left ventricular ejection fraction of at least 40% (myeloablative regimen 4, reduced intensity regimen 3) or 30% (nonmyeloablative regimen 2)
Creatinine < 1.6 mg/dL (myeloablative regimen 4, reduced intensity regimen 3) or < 3.0 mg/dL (nonmyeloablative regimen 2)
Serum glutamate pyruvate transaminase (SGPT) =< to 2.0 x normal (myeloablative regimen 4, reduced intensity regimen 3) or =< 4.0 x normal (nonmyeloablative regimen 2)
Bilirubin =< to 2.0 x normal (myeloablative regimen 4, reduced intensity regimen 3) or =< 4.0 x normal (nonmyeloablative regimen 2)
TIER I SUBJECTS: Patients with relapsed follicular lymphoma achieving at least a PR following their most recent systemic chemotherapy and/or immunotherapy regimen; Tier I subjects must have had at least two prior chemotherapy and/or immunotherapy regimens; partial response from pre-study regimen may be either a clinically determined response by the principal investigator or physician co-investigator member of the study team, or a measured response as per the response criteria of this protocol
Progressed or intolerant to at least 1 approved prior anticancer regimen.
More than one prior treatment regimen for ALL or LL
Has experienced failure of at least 1 prior chemotherapy regimen:
Insufficient time from last prior regimen or radiation exposure (washout period of 4 weeks)
Participants must be on a stable antiretroviral regimen per current International Acquired Immunodeficiency Syndrome (AIDS) Society guidelines as follows, with no intention of changing the regimen within 8 weeks after ibrutinib initiation:\r\n* Choice of regimen: The specific antiretroviral agents are at physician discretion, and the use of investigational agents currently available on an expanded-access basis is allowed; use of experimental antiretroviral agents or those containing zidovudine (including Combivir and Trizivir) is prohibited\r\n* Patients with mantle cell lymphoma, CLL, or SLL must be on non-cytochrome P450, family 3, subfamily A, polypeptide 4 (CYPA3A4) modulating antiretroviral agents (Stratum C) to be eligible for this study\r\n* Patients may be switched to non-conflicting regimens in order to participate\r\n* Stability of regimen: With the exception of patients on zidovudine-based ART, any changes in antiretroviral regimen must be made at least 4 weeks prior to ibrutinib initiation; patients taking zidovudine-based ART must change to a non-zidovudine-based regimen at least 2 weeks prior to ibrutinib initiation; changes to ART therapy during the study may be made if medically necessary (e.g. toxicity, treatment failure)
4. Received only one prior chemotherapy regimen consisting of ? 4 cycles of pemetrexed/cisplatin or pemetrexed/carboplatin; subjects must have documentation of an ongoing response (confirmed PR or SD) following completion of this regimen. Subjects changing from cisplatin to carboplatin or vice versa within the same course of treatment because of platinum toxicity will be considered to have had first-line chemotherapy. Note: Subjects may have undergone previous surgical resection of their disease providing it was completed prior to initiation of chemotherapy.
Histologically confirmed biliary tract or gallbladder cancer that have relapsed or are refractory after one prior gemcitabine-based chemotherapy regimen for advanced biliary cancer
Treatment with more than one prior chemotherapy regimen
Receipt of prior chemotherapy (CT) or radiation therapy (RT) for PTCL, other than a single allowed CHOP regimen, except:
MESOTHELIOMA COHORTS (COHORTS 1 AND 2 ONLY): Patients must have had at least one prior chemotherapy regimen, with the Food and Drug Administration (FDA)-approved regimen of a platinum-based therapy in combination with pemetrexed being preferred unless there was a specific contraindication for an individual patient; there is no limit to the number of prior chemotherapy regimens received
Patients with relapsed chronic lymphocytic leukemia with high risk features: lack of objective response or relapse within 6 months following nucleoside-analogue based chemotherapy regimen or patients with 17p deletion CLL who lacked objective response to at least 1 preceding chemotherapy regimen
Patients with malignant pleural disease (MPD), pathologically confirmed at Memorial Sloan-Kettering Cancer Center (MSKCC) (radiographic confirmation is acceptable for screening phase eligibility), and defined as one of the following (patients who have not yet received treatment may enroll in the screening portion only):\r\n* Malignant pleural mesothelioma – previously treated with at least one prior treatment regimen\r\n* Non-small cell lung cancer metastatic to the pleura—previously treated with at least one prior treatment regimen (chemotherapy, surgery, or targeted agent) and documented progression of disease; patients with disease outside of the pleura will be discussed among study principal investigator (PI) and Co-Pls prior to considered eligible for the study; disease outside of the pleura must not require any immediate therapy per PI’s discretion\r\n* Breast cancer metastatic to the pleura— previously treated with at least one prior treatment regimen (chemotherapy, surgery or targeted agent) and documented progression of disease; patients with disease outside of the pleura will be discussed among study PI and Co-Pls prior to considered eligible for the study; disease outside of the pleura must not require any immediate therapy per PI’s discretion
Any of the following as this regimen may be harmful to a developing fetus or nursing child:
Maximum one prior systemic therapy regimen.
Participants must have received at least one prior chemotherapy regimen for AGC;\n             prior therapy does not need to have included HER2-directed therapy.
A) Dose Escalation Stage: Confirmed diagnosis of relapsed or refractory Non-Hodgkin Lymphoma (NHL) treated with prior treatment for lymphoid malignancy comprising of at least 1 regimen containing a therapeutic anti-CD20 antibody (eg, rituximab, ofatumumab, GA-101) and at least 2 prior combination chemotherapy regimens (or autologous stem cell transplant) , or treated with 1 prior combination chemotherapy regimen in patients without an approved second-line therapy option, requiring treatment in the opinion of the treating physician
Expansion Cohort A: Relapsed or refractory DLBCL treated with prior treatment for lymphoid malignancy comprising of at least 1 regimen containing a therapeutic anti-CD20 antibody (eg, rituximab, ofatumumab, GA-101) and at least 2 prior combination chemotherapy regimens or autologous stem cell transplant, or treated with 1 prior combination chemotherapy regimen in patients without an approved second-line therapy option, requiring treatment in the opinion of the treating physician
Expansion Cohort B: Diagnosis of relapsed or refractory B-cell NHL (other than DLBCL) treated with prior treatment for lymphoid malignancy comprising of at least 1 regimen containing a therapeutic anti-CD20 antibody (eg, rituximab, ofatumumab, GA-101) and at least 2 prior combination chemotherapy regimens or autologous stem cell transplant, or treated with 1 prior combination chemotherapy regimen in patients without an approved second-line therapy option, requiring treatment in the opinion of the treating physician
> 1 prior regimen
Disease refractory to last myeloma regimen.
Previously received one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least PR or documented PD after, the most recent systemic treatment regimen
Patients must have received one of the regimens listed below for their platinum sensitive disease; the number of treatment cycles should not have exceeded 8 cycles of 1 regimen in the recurrent setting; the most recent dose of the regimen must have been given within 3 to 8 weeks prior to the first dose of study drug; there is a required 3 week washout from the last dose of chemotherapy; if greater than 8 weeks have passed since the last chemotherapy dose, patients may be eligible with documented approval of the Principal Investigator\r\n* Platinum (carboplatin or cisplatin) and taxane (paclitaxel or docetaxel)\r\n* Carboplatin and gemcitabine\r\n* Carboplatin and liposomal doxorubicin\r\n* Any other carboplatin doublet (including carboplatin and pralatrexate) with documented approval of the Principal Investigator
Bevacizumab-naïve patients: these patients may not have more than one prior relapse not counting the current relapse being treated by this protocol and must have received at least one prior chemotherapy regimen, which must have included temozolomide
For the Phase 1b portion of the study, more than 3 prior chemotherapy regimens and for the Phase 2 portion of the study more than 2 prior chemotherapy regimens. Maintenance therapy following induction chemotherapy does not count as a separate regimen. In addition, hormonal therapy (e.g., tamoxifen or an aromatase inhibitor) does not count as a separate regimen.
Pregnant or lactating in female patients, if applicable (childbearing potential who have received a reduced intensity conditioning regimen)
At least 1 prior regimen must have contained a platinum salt
'Adjuvant therapy' will constitute a prior treatment regimen
Any prior chemotherapy must have been completed >= 2 weeks prior to day 1 of study treatment and the participant must have recovered to eligibility levels from prior toxicity\r\n* Only one prior regimen is allowed for relapsed AML patients; note one prior regimen is defined as follows:\r\n** Induction chemotherapy followed by consolidation is considered one regimen\r\n** Induction chemotherapy followed by re-induction in case of persistent disease followed by consolidation is considered one regimen\r\n* Hydroxyurea is allowed prior to day 1 of study treatment to keep white blood cell (WBC) below 20 K
Patients with transformed CTCL eligible for CHOP regimen
Subjects must not have had more than 1 previous treatment regimen with chemotherapy, interferon, or IL-2 for metastatic melanoma
More than 1 prior systemic regimen (prior MET inhibitors/antibodies are not allowed; experimental systemic therapy for inoperable HCC given before or after sorafenib counts as separate regimen and is not allowed)
If the participant has received prior bendamustine, response duration must have been greater than (>) 1 year (for participants who have relapse disease after a prior regimen)
On a stable parental study regimen (at least one cycle for the regimen at the dose/schedule that is to be given in the Treatment Extension study must have been given prior to the patient's discontinuation from the parental study). Signed written informed consent.
All patients must be prescribed combination antiretroviral therapy with the goal of virological suppression using an acceptable regimen that adheres to national guidelines for treatment of HIV infection; non-suppressed, treatment experienced patients, defined as patients with a viral load > 400 copies/mL who have been on antiretroviral therapy for more than 4 months can be enrolled if an alternative ART regimen is available that includes at least two ART drugs that, in the opinion of the site investigator, are expected to have activity based on genotypic testing (if available) and treatment history
An interval of at least 3 months from the completion of most recent radiation therapy; at least 4 weeks from a non-nitrosourea chemotherapy regimen and at least 6 weeks from a nitrosourea containing regimen
Have received or refused at least one chemotherapy regimen
Recipient must have no evidence of active infection at the time of the transplant preparative regimen or at time of transplantation.
Documentation for inclusion criteria histologically proven, unresectable, locally advanced or metastatic liposarcoma (dedifferentiated, myxoid round cell, or pleomorphic) or leiomyosarcoma. Participants must have a pathology report indicating the diagnosis of liposarcoma or leiomyosarcoma that has been reviewed by the sponsor before randomization may occur and treated in any order with at least: an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen do not need to be reviewed by the Sponsor
Participating patients must receive medically appropriate care and treatment for HIV infection, including antiretroviral medications, when clinically indicated, and should be under the care of a physician experienced in HIV management; with the exception of treatment with zidovudine and stavudine, patients will be eligible regardless of antiretroviral regimen (no antiretroviral therapy, nonnucleoside reverse transcriptase inhibitors [NNRTI]-based therapy, or protease inhibitor based therapy), provided there is no intention to initiate therapy or the regimen has been stable for at least 4 weeks with no intention to change the regimen within 8 weeks following study entry; the exact regimen used for HIV therapy will be captured on Case Report Forms; as study-specific (antiretroviral therapy-based) strata fill, however, only patients fitting the remaining open strata will be accrued
Has received ? 3 prior chemotherapy regimens in any setting (a regimen is defined as any agent[s] that has been administered for more than 1 cycle; sequential neoadjuvant/adjuvant treatment is considered 1 regimen)
Patients with recurrent or progressive advanced stage NSCLC (no small cell lung cancer [SCLC] component) who have been treated with at least one and a maximum of two prior chemotherapy regimens for advanced NSCLC; chemotherapy as part of initial potentially curative therapy (given as part of adjuvant or concomitant chemoradiotherapy) that was completed < 1 year counts as 1 prior regimen; prior erlotinib, other EGFR tyrosine-kinase inhibitors (TKIs) or monoclonal antibodies targeting EGFR are not allowed; NOTE: Chemotherapy as part of initial potentially curative therapy (given as part of adjuvant or concomitant chemoradiotherapy) that was completed one or more years prior to screening for this study does not count as a prior regimen; if the tumor is refractory (progressed) after a prior chemotherapy regimen, then that regimen would count; if a prior chemotherapy regimen has been changed due to other reasons than disease progression (e.g. poor tolerance, allergic reaction), then it would not count as a separate prior regimen; a chemotherapy drug added for “maintenance” following disease stabilization or response to a chemotherapy regimen (in the absence of prior disease progression) does not count as a separate prior regimen; NOTE: Pathology reports documenting the diagnosis of NSCLC are required to be reviewed by the screening physician investigator
Achieved a response to at least one prior regimen
Suitable for either treatment regimen.
Subjects must be discontinued from ipilimumab or nivolumab as monotherapy or with the combination regimen
Be scheduled to receive an antiemetic regimen that does not contain Akynzeo; in addition, the antiemetic regimen must conform with American Society of Clinical Oncology (ASCO) Clinical Practice Guidelines at cycle 1
Plan to start a new cancer treatment regimen within 4 weeks from time of baseline registration; the treatment regimen is up to the discretion of the treating oncology physician; the regimen must include a chemotherapy drug or other agents that have similar prevalence of toxicity; patients who will receive monoclonal antibody therapy or other cancer therapies (e.g., tyrosine kinase inhibitors) are eligible if the other agents present a prevalence of toxicity similar to chemotherapy; these therapies can be used in combination with chemotherapy, as a single agent, or in combination with each other\r\n* Chemotherapy will be defined as cytotoxic drugs; in addition, agents (e.g., monoclonal antibodies and targeted agents) that have a prevalence of grade 3-5 toxicity in older patients similar to chemotherapy (> 50%) will be allowed; a list of allowable agents (single and in combination) meeting this toxicity criteria will be available on the University of Rochester Cancer Center (URCC) NCORP Research Base website as part of the study materials; given the rapidly changing landscape of new drugs for cancer, the study team led by the principal investigator (PI) will update the list accordingly after reviewing the toxicity profile of new therapies; if the potentially eligible participant is to receive an approved drug or regimen not on the list, contacting the URCC NCORP Research Base study team is required for approval prior to participant enrollment\r\n* Patients who are receiving approved cancer treatment in combination with radiation are eligible\r\n* A patient may also be enrolled on a treatment trial and participate in this study, if all other inclusion and exclusion criteria are met
Must be starting a new chemotherapy regimen (patients whose treatment regimen includes an immunomodulatory agent such as lenalidomide or small molecule targeted agents such as ibrutinib or idelalisib will be included in the study; patients being treated with a single agent monoclonal antibody will not be included)
Patients on ongoing chemotherapy regimen at the time of eligibility:
BC patients scheduled to undergo chemo regimen other than the 12-week, 16-week, 18-week, 20-week, or 24-week regimen
Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug. Additional Exclusion Criteria for the SC-006 and ABBV-181 Combination Treatment Regimen:
Preparative regimen: both reduced intensity and ablative regimens are permitted; each center will pre-specify the regimen they intend to use during the conduct of the study
Subjects who have taken a neurokinin antagonist within 14 days prior to beginning the BEAM regimen
Scheduled to start a new treatment regimen for MBC, but no more than 3 previous chemotherapy regimens
Planned chemotherapeutic regimen for subject must meet all of the following criteria:\r\n* A known myelosuppressive regimen which includes a combination of at least two of the following agents: actinomycin, carboplatin, cisplatin, cyclophosphamide, daunorubicin, doxorubicin, etoposide, ifosfamide, topotecan\r\n* At least 4 consecutive cycles\r\n* Cycle length is either 14 or 21 days\r\n* Regimen must either alternate chemotherapeutic agents in an X-Y-X-Y format, such that the same chemotherapy is given every other cycle (e.g. vincristine/doxorubicin/cyclophosphamide | ifosfamide/etoposide), or repeat the same chemotherapeutic agents each cycle in an X-X-X-X format (e.g. repeated cycles of cisplatin/etoposide/bleomycin); questions regarding whether or not a patient’s chemotherapy plan meets inclusion criteria will be decided by the study chair
Planned to initiate a new systemic chemotherapy regimen (including patients starting on first chemotherapy or patients previously treated but starting on a new regimen)
ONCOLOGY PATIENTS: patients with an oncology diagnosis that are or will be on a chemotherapy regimen that will last for an additional >= 3 months or are on or will be on a chemotherapy regimen for < 3 months and then proceed to transplant (allogeneic or autologous stem cell rescue) during the 3-month study period
Starting a new treatment regimen that includes a single oral anticancer medication
At least one prior chemotherapeutic regimen for advanced metastatic/recurrent disease, of which at least one regimen included a platinum agent (unless contraindicated)
Treated with any established chemotherapy regimen based on either:
Chemotherapy regimen: Docetaxel/carboplatin. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, & 3.
Chemotherapy regimen: Docetaxel/cyclophosphamide. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, & 3. Note: Fosaprepitant will be allowed in place of aprepitant, and either granisetron or ondansetron, on one or more days, will be allowed in place of palonosetron.
Nonmyeloablative preparative regimen
ANNUAL SCREENING REGIMEN ELIGIBILITY CHECK
Planned reduced intensity conditioning regimen (see eligible regimens in Table 2.4a)
Receiving a stable dose of octreotide LAR as a part of a treatment regimen for >= 3 months
Patients must have planned treatment with doxorubicin:\r\n* Patients with sarcoma must have an initial planned regimen including 75 mg/m^2 doxorubicin for at least 4 cycles; NOTE: patients can be on additional chemotherapeutic agents \r\n* Patients with lymphoma must have an initial planned regimen including 50 mg/m^2of doxorubicin for at least 6 cycles; NOTE: patients can be on additional chemotherapeutic agents\r\n* Patients with breast cancer must have an initial planned regimen including 60 mg/m^2 of doxorubicin for at least 4 cycles; breast cancer patient enrollment will stop once 60 breast cancer patients have been enrolled; NOTE: patients can be on additional chemotherapeutic agents
Had at least 1 prior anti-MM regimen and no more than 3 prior anti-MM regimens. Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 anti-MM regimen.
Pregnant women are excluded from participation due to inability to participate in required chemotherapy regimen
Patients with prior anthracycline therapy will be excluded
Any prior anthracycline or platinum based therapy at any time
Patient must have progressed or be refractory to prior anthracycline-containing chemotherapy (e.g. R-CHOP, DA-EPOCH-R, etc)
LVEF within normal limits if patient received prior anthracycline therapy [Period 1].
For lymphoma patients only: At least one prior systemic chemotherapy including an alkylating agent and anthracycline (unless contraindicated), and an anti-CD20 monoclonal antibody if the tumor is CD20+; prior treatment with anthracycline and alkylating agent is not required for patients with natural killer (NK)/T cell lymphoma but prior treatment with platinum based chemotherapy and/or l-asparaginase is required
Any patient with the diagnosis of locally advanced, unresectable or metastatic soft tissue or bone sarcoma (except GIST and Kaposi’s) from any site. A minimum of 1 prior chemotherapy regimen, including adjuvant or neo-adjuvant therapy for the treatment of sarcoma. Patients eligible for an anthracycline should have received a prior anthracycline containing regimen. Patients who decline or are not eligible for anthracycline treatment may be considered for this protocol as a first line treatment. Patients with a diagnosis of liposarcoma should also have received eribulin if they received anthracycline-based therapy prior to eribulin. Patients with a diagnosis of myxoid liposarcoma should have received trabectedin. Patients with angiosarcoma should have received either taxol or docetaxel. Patients must have measurable disease defined as at least 1 lesion >= 1 cm in the greatest dimension
Have had prior therapy (administered in the neoadjuvant, adjuvant, and/or metastatic setting) with an anthracycline, a taxane, and capecitabine (prior anthracycline can be omitted if not medically appropriate or contraindicated for the patient).
Participants that have received prior anthracycline therapy if the participant is to be enrolled in the doxorubicin combination arm.
(For cohort B only): Patients must have at least 3 and no more than 5 weeks between anthracycline-based therapy and start of treatment with mirvetuximab soravtansine
An anthracycline containing chemotherapy regimen
Prior systemic therapy with an anthracycline for any indication
Patients with a total lifetime anthracycline exposure exceeding the equivalent of 900 mg/m^2 of daunorubicin
Has prior treatment using an anthracycline
Patients who have received any other previous antitumor therapies (other than anthracycline-based neoadjuvant chemotherapy for the current cancer event)
Subjects requiring daily corticosteroids, other than those given as premedication for the anthracycline-based chemotherapy
Patients must have received at least one dose of an anthracycline based neoadjuvant regimen; patients are eligible if therapy was discontinued due to disease progression or therapy intolerance
Patients with less than a 1.0 cm measurable residual disease after neoadjuvant anthracycline based chemotherapy
Subjects with a history of tumor progression within 30 days of anthracycline administration are not eligible. However, subjects who have previously received an anthracycline and subsequently relapse greater than 30 days after their most recent prior dose of anthracycline will be eligible.
No more than 2 prior induction regimens (excluding prior HSCT) in their first line treatment and one must have included cytarabine with an anthracycline (or anthracenedione)
Received at least one dose of an anthracycline-based NACT; patients are eligible if therapy was discontinued due to disease progression or therapy intolerance
At least 1.0 cm of measurable residual disease after neoadjuvant anthracycline-based chemotherapy
ELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: If a patient has received anthracycline chemotherapy after enrollment, they must have demonstrated adequate cardiac function at any time following latest administration of an anthracycline chemotherapy (does NOT need to be within 48 hours of T cell infusion) defined as shortening fraction > 28% by echocardiogram or an ejection fraction > 50% by MUGA
Have previously received any anthracycline outside the protocol
Patients >= 60 are eligible if not a candidate for standard cytarabine plus anthracycline chemotherapy as determined by Kantarjian’s score; patients younger than 60 may also be included if felt not to be a candidate for intensive anthracycline plus cytarabine based chemotherapy
Previous treatment must include treatment with a single line of chemoimmunotherapy containing an anthracycline and a CD20-targeted agent
Subjects have received at least 4 but no more than 8 cycles of first-line anthracycline or ifosfamide containing systemic anti-cancer therapy regimen
Have received first-line systemic anti-cancer therapy with an agent other than anthracycline or ifosfamide
Patients for whom anthracycline, paclitaxel or antibody therapies are contraindicated: \r\n* Hypersensitivity reactions to any of the medications or to humanized monoclonal antibodies \r\n* History of congestive heart failure \r\n* Myocardial infarction within the past 12 months \r\n* Pre-existing peripheral neuropathy >= grade 2 \r\n* Prior anthracycline therapy with >= cumulative dose of 240 mg/m^2
Prior exposure to PLD or anthracycline therapy.
Previous therapy with anthracycline, taxanes, carboplatin, trastuzumab, or other HER2 targeted therapies for any malignancy
Patients must not have received previous systemic anthracycline (intravesical anthracycline is allowed)
Current anthracycline use
Must have progressed following or have been unable to tolerate at least one prior anthracycline or alkylating agent containing regimen (with or without anti-CD20).
Patients must have no prior radiation therapy to >= 25% of the bone marrow for prior systemic anthracycline therapy; prior intravesical anthracycline therapy for non-muscle invasive urothelial carcinoma of the bladder is permitted
Prior anthracycline therapy
Has received a prior anthracycline chemotherapy either for ovarian cancer treatment or another previous malignancy
For stratum A, patients must not have received prior anthracycline-based therapy (prior treatment with non-anthracyclines is permitted)
For stratum C, patients must have received prior anthracycline therapy anthracycline (or have a contraindication to anthracycline) or gemcitabine-based therapy (or have a contraindication to gemcitabine)
Prior anthracycline therapy
Patients who are high risk for developing the following anthracycline, paclitaxel, trastuzumab or pertuzumab related toxicities including:\r\n* History of congestive heart failure, myocardial infarction or cardiomyopathy, uncontrolled hypertension despite adequate medications\r\n* Pre-existing peripheral neuropathy >= grade 3 \r\n* Prior anthracycline therapy\r\n* Known hypersensitivity to any of the study medications\r\n* Patients older than age 65 due to increased risk of cardiotoxicity
Prior anthracycline use >=150 mg/m2
Participants who have previously received doxorubicin, any other anthracycline chemotherapy or bevacizumab
Patents who received an anthracycline prior to enrollment must have an ejection fraction ? 50%
A minimum of 1 and a maximum of 3 prior chemotherapy regimens, including adjuvant and neo-adjuvant therapy for the treatment of sarcoma; patients eligible for an anthracycline should have received a prior anthracycline containing regimen; patients who decline or are not eligible for anthracycline treatment may be considered for this protocol as a first line treatment
Completion of at least 4 cycles of a rituximab-containing, anthracycline-based combination chemotherapy regimen no sooner than 3 weeks and no longer than 8 weeks prior to the start of radiation therapy
Must not have received an excessive cumulative dose of anthracycline
Previous treatment with anthracycline antibiotics (e.g. Doxorubicin) or sorafenib.
The patient has been exposed to >= 350mg/m^2 of anthracycline
Prior anthracycline exposure: Patients must have less than 400 mg/m2 lifetime exposure of anthracycline chemotherapy. (See Appendix II for calculation worksheet)
42 days for nitrosureas, mitomycin C, and liposomal anthracycline
Subjects who received prior anthracycline therapy
an anthracycline containing chemotherapy regimen
Prior anthracycline therapy
Prior exposure to the an anthracycline.
Prior extensive anthracycline exposure
Previous history of exposure to an anthracycline compound.
Previous anthracycline-based chemotherapy (daunorubicin, doxorubicin, epirubicin, idarubicin, mitoxantrone and valrubicin), in any formulation.
Treated in any order with at least: an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen
Treated in any order with at least: an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen with less than 3 weeks from last dose of systemic anticancer therapy, radiation therapy, or therapy with any investigational agent
Prior anthracycline exposure: patients must have had less than 350 mg/m^2 lifetime exposure of anthracycline chemotherapy
Has received prior anthracycline therapy
Are unable to receive anthracycline therapy due to previous toxicity.
Subject must have previously received or be intolerant to anthracycline based therapy for advanced (metastatic or inoperable) disease. Subjects who received neoadjuvant/adjuvant anthracycline based therapy and progressed within 6 months of completion of therapy will be eligible
Patients who are receiving therapy with an anthracycline
Previous anthracycline exposure
Patient’s current chemotherapy treatment plan must include at least 1 course of:\r\n* Cisplatin at ? 50 mg/m²/dose\r\n* Ifosfamide plus etoposide or doxorubicin or\r\n* Cyclophosphamide plus an anthracycline
Patient must have a lifetime cumulative anthracycline dose of >= 250 mg/m^2 DOXOrubicin equivalent without the protection of dexrazoxane (Zinecard) therapy; the anthracycline dose threshold must be met as part of the treatment of a cancer that was diagnosed at < 22 years of age\r\n* Note: Institutional records (e.g., clinic note, treatment summary, chemotherapy roadmap) can be used to document lifetime receipt of anthracycline dose
Scheduled to receive anthracycline-based chemotherapy therapy
Scheduled to receive chemotherapy with an Anthracycline (doxorubicin or epirubicin)
Have either received prior anthracycline treatment or have a reason not to receive anthracycline in the judgment of their treating physician
an anthracycline containing chemotherapy regimen