a study evaluating talazoparib in relapsed ovarian, fallopian tube, and peritoneal cancer

Conditions: Ovarian Cancer

Summary: the purpose of this phase 2, multiple-cohort, randomized, open-label, international study of talazoparib (a poly (adp-ribose) polymerase (parp) inhibitor) is to compare the efficacy and safety of talazoparib monotherapy and talazoparib plus temozolomide in women with relapsed ovarian, fallopian tube, and peritoneal cancer.


Eligibility criteria:
inclusion criteria: * women ≥ 18 years of age and willing and able to provide informed consent * relapsed, histologically confirmed ovarian, fallopian tube, and peritoneal cancer. histologic subtypes include serous, endometrioid, clear-cell, mixed, undifferentiated histology, and carcinosarcoma. * sufficient archival tumor tissue available or consent to a fresh tissue biopsy for biomarker analysis. consent to blood sample collection for biomarker analysis is required. * disease progression per recist 1.1 during or after the last treatment. have metastatic disease with at least 1 target tumor lesion measurable per recist 1.1 on the screening scan. lesions used for biopsies cannot be designated as a measurable lesion for recist 1.1 assessments. * additional criteria for cohort 1 include the following: * have a deleterious germline or a somatic brca1 or brca2 mutation, or a high diagnostic hrd test score (mychoice score ≥ 42), which represents a loss of dna repair function based on testing performed at a sponsor-approved laboratory * received at least 1 and no more than 3 platinum-based chemotherapy regimens (prior bevacizumab is allowed) and the last dose is ≥ 28 days before randomization * no prior parp inhibitor treatment (cohort 1 only) * additional criteria for cohorts 2 and 3 include the following: * received at least 2 platinum-based chemotherapy regimens (including first-line chemotherapy; prior bevacizumab is allowed) and the last dose is ≥ 28 days before randomization * received prior parp inhibitor treatment as a single agent or in combination therapy regimen and the last dose is ≥ 28 days before randomization, as follows: * for cohort 2 only: received parp inhibitor treatment for ≥ 6 months and had a response of cr, pr, or stable disease for ≥ 6 months * for cohort 3 only: received parp inhibitor treatment for \< 6 months with no response (disease progression or stable disease) * eastern cooperative oncology group (ecog) performance status of ≤ 2. * estimated life expectancy of ≥ 3 months. * able to swallow drugs, have no known intolerance to study drugs or excipients, and able to comply with study requirements. exclusion criteria: * have not recovered (recovery is defined as national cancer institute common terminology criteria for adverse events \[ctcae\] grade ≤ 1) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements. * use of any investigational agent within 14 days before randomization. * had \> 2 paracentesis procedures within 28 days before randomization. * major surgery within 14 days before randomization. * requirement for intravenous alimentation (at the time of randomization). * diagnosis of mds.