Recurrent, platinum resistant ovarian cancer (defined as progression within < 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 or ). Participants should have either platinum-refractory (disease progression during initial platinum therapy) or platinum-resistant (disease progression < months after completion of platinum therapy) disease.
Cohort A Dose Escalation (Ribociclib + PDR): 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 >= 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 to months of prior platinum-based chemotherapy
Ovarian cancer patients must be resistant to platinum therapy (i.e. within months of last platinum therapy)
Patients must have recurrent platinum-resistant disease, defined as progression < 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 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 months of completing, platinum-based chemotherapy
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 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 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 months of completing a first-line platinum-based regimen.
Part ,Cohort , Must have received only 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 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 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 investigators opinion, patients would benefit from treatment on current protocol
Resistant/Refractory Small Cell Carcinoma (SCC) patients in rd line or beyond that have previously received platinum or patients in nd 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 months. EOC - specific criteria: Patients who progress or have stable disease during first-line treatment or who relapse within month are considered to be 'platinum-refractory'. Patients who respond to primary treatment and relapse within months are considered 'platinum-resistant', and patients who relapse more than months after completion of initial therapy are characterized as 'platinum-sensitive'. Patients who relapse - 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 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 , 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 gBRCA/m test; patients should have recurrent platinum-resistant - defined as disease recurrence by imaging within months of the last receipt of platinum-based chemotherapy; rising CA only is not considered as platinum-resistant disease; patients with primary platinum refractory disease defined as progression during or within months after receiving first-line platinum based chemotherapy are not eligible
Patients enrolling in cohort , 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 gBRCA/m test; patients should have recurrent platinum-resistant, defined as disease recurrence by imaging within months of the last receipt of platinum-based chemotherapy; this cohort should have measurable (defined by RECIST v.) but without biopsiable disease, determined by principle investigator (PI) and interventional radiology (e.g., cystic abnormal mass, not safely biopsiable disease); rising CA only is not considered as platinum-resistant disease; patients with primary platinum refractory disease defined as progression during or within months after receiving first-line platinum based chemotherapy are not eligible
Patients must have platinum resistant (platinum-free interval < 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 months of platinum based chemotherapy)/refractory (disease progression during or following the 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 months of completing first platinum regimen)
Patients must have received prior platinum and pemetrexed based therapies. Response to platinum is not an eligibility criterion for enrollment
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 patients 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 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 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 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 months
Patients must have recurrent, platinum-resistant disease (defined as having relapsed within 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-NK as nd line (as st 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 (< months) following the completion of treatment\r\n* Platinum sensitive: may receive FATE-NK as rd line therapy (as nd 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 (>= 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 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 > months after completing last platinum-based chemotherapy) eligible to receive platinum-based doublet chemotherapy
Platinum-resistant disease (as defined as progressive disease within 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 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 >= 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 BRCA or BRCA deleterious alteration\r\n* A somatic mutation in BRCA or BRCA 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 months)\r\n** Platinum-resistant is defined as relapse within months of last platinum-based chemotherapy or progression while on platinum-based therapy
Participant can be either platinum-sensitive (platinum free interval [PFI] >= months prior to recent recurrence) or platinum-resistant (PFI < 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)
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 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 .; platinum-refractory disease is defined as progressive disease on cisplatin or carboplatin therapy or within 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 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 months from last platinum-based treatment to recurrence or progression during platinum based therapy
Hypersensitivity to platinum agents
No more than 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 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 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 ).
Platinum resistant or refractory disease as defined by progression of disease on a platinum-containing regimen or recurrence of disease within 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 months after last platinum regimen; platinum refractory disease is allowed
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 portion of the study, patients must have a platinum free interval between months and 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 months of the last receipt of platinum-based chemotherapy; rising CA only is not considered as platinum-resistant or refractory disease
No more than prior treatment regimens (including primary therapy; no more than 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 months of last platinum therapy); patients who received greater than two prior platinum containing regimens will not be eligible
Patients refractory to primary platinum therapy where \refactory\ is defined as\n disease progression within months of first dose of initial platinum-based therapy.
Patients whose ovarian cancer recurs/progresses within - 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 - 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 months after completion of platinum-based treatment are considered 'platinum sensitive' and will not be eligible for this trial, since they have a favorable (-%) 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 months after the last platinum based therapy or relapse during platinum therapy; platinum-resistance is defined as relapse within to months after last dose of platinum-based chemotherapy; platinum sensitivity is defined as a relapse greater than months after last dose of platinum-based chemotherapy; participants with platinum-sensitive disease must have progressed after receiving prior platinum-based chemotherapy regimens
Adult patients with documented deleterious BRCA or 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 months after their last platinum dose (i.e., platinum-free interval is > 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 months of their last platinum dose (i.e., platinum-free interval is =< 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 months from completion of a minimum of four cycles of platinum-containing therapy.
Progressed or recurred within months of completing platinum therapy or received > 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 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 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 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 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 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 months of first-line platinum therapy)
Platinum resistant/refractory disease, defined as disease progression within 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 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 < 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 CA 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 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 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 months, have persistent disease at the completion of primary platinum-based therapy or have progressed during platinum-based therapy; patients with greater than 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 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 < months from completion of a minimum of platinum therapy cycles (+ days); the date should be calculated from the last administered dose of platinum therapy)
Platinum-free interval (PFI) - patients must have progressed < 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
Patients with platinum resistant cancer
If the patient has platinum-sensitive relapsed disease (first relapse > 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 months ( days) of the last receipt of platinum-based chemotherapy
Participants with platinum-resistant or platinum-sensitive disease (within months) are eligible; platinum-resistant disease is defined as relapse within months after the last dose of platinum-based chemotherapy; platinum-sensitive disease is defined as relapse greater than months after the last dose of platinum-based chemotherapy; participants with platinum-sensitive disease who have experienced relapse within to months after the last dose of platinum-based chemotherapy are eligible; participants with primary platinum-refractory disease (defined as progression during or relapsed within 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 months after initial platinum-based chemotherapy
Patients with platinum-sensitive disease with relapse greater than months after the last dose of platinum-based chemotherapy are ineligible
Patients must have platinum resistant cancer with a platinum free interval of < 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 ..) 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 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 > AND < months after completion of the most recent platinum-based therapy.
Evidence of platinum-refractory ovarian cancer defined as recurrence or progression during the first cycles of or < months after the beginning of first-line platinum based chemotherapy.
Evidence of platinum-resistant ovarian cancer defined as recurrence or progression within months after completing the most recent platinum-based therapy.
Disease must have been persistent or have recurred within months ( 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- nadir (however, that will need a confirmatory CA- to be done at least weeks or later and the patient will need to have detectable disease\r\n* While the disease must have been persistent or progressive within months of a prior platinum therapy, the patient may be enrolled and begin treatment up to months ( 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 ..) 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 < 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: - months after last platinum-containing chemotherapy).
For platinum-resistant or -refractory cohort\r\n* Disease that has progressed within months of the last receipt of platinum-based chemotherapy\r\n* No more than 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 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 %) 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
Tumor progression or recurrence within months of the last dose of any number of platinum-based and cetuximab therapy lines in the adjuvant, primary, recurrent, or metastatic setting; must be resistant (not responding) to both platinum and cetuximab
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
Known standard therapy for the patients 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 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 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 < months from completion of a minimum of 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 > months or =< than months after completion of frontline platinum based chemotherapy
Subject is platinum sensitive (progression free interval >= months prior to recent recurrence) or platinum resistant (progression free interval < months prior to recent recurrence)
Subjects must be partially-platinum-sensitive (defined as progression to months after the end of the last platinum-based chemotherapy) or platinum sensitive (defined as progression > months after the end of the last platinum-based chemotherapy);
Subjects who have platinum-resistant or refractory disease defined as progression during or within 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- 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 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 > 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
Patients must be platinum resistant defined as progressive disease while receiving platinum therapy or within 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 months platinum-based chemoradiation with curative intent or any disease progression on platinum-based chemotherapy in the absence of radiation.
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 < 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 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than month period between penultimate platinum regimen and progression of disease)
Platinum-refractory germ-cell tumors.
Platinum resistant/refractory disease, defined as disease progression/relapse within 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 - months following platinum-based chemotherapy have platinum resistant disease; such patients are eligible for this trial
Patients with documented disease recurrence/progression within - 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 months after completion of platinum-based treatment are considered platinum sensitive and will not be eligible for this trial
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 weeks from the last day of platinum administration
For Stage : Participants with non-mucinous, platinum-resistant ovarian cancer with documented radiographic progression or relapse according to RECIST within months of receiving platinum-based chemotherapy
Participants who are allergic to platinum agent
Refractory to platinum-based therapy (defined as disease progression within 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 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 < 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 must have had an objective response to prior platinum-based therapy with subsequent progression ? days after the last dose of platinum
Participants in Cohort must have either not had an objective response to prior platinum based therapy or had progression < days after the last dose of platinum
Has received a platinum compound and/or a taxane
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:()Platinum-resistant: a response to platinum therapy followed by progression within months after completing therapy ()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 prior systemic cytotoxic regimens
Patient must have suspected platinum-resistant disease (disease progression =< 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 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.
If the participant has received prior therapy with platinum, the time to the first treatment of study drug from the last platinum exposure is > 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 > days.
Documented platinum-resistant or platinum-refractory disease. Platinum-resistant disease is defined as progression within < months from completion of a minimum of 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.