Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT02836028
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02836028
Study Brief:
Protocol Section:
NCT02836028