- 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
- 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
- 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
- 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 (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.
- 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.