Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected
Public ClinicalTrials.gov record NCT04729387. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
EPIK-O: A Phase III, Multi-center, Randomized (1:1), Open-label, Active-controlled, Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Olaparib as Compared to Single Agent Cytotoxic Chemotherapy, in Participants With no Germline BRCA Mutation Detected, Platinum-resistant or Refractory, High-grade Serous Ovarian Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this study was to evaluate the efficacy and safety of alpelisib in combination with olaparib compared with single-agent cytotoxic chemotherapy in participants with platinum-resistant or platinum-refractory, germline BRCA non-mutated (gBRCAnm) high-grade serous ovarian cancer (HGSOC), with progression-free survival (PFS) as the primary efficacy endpoint.
Study identification
- NCT ID
- NCT04729387
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 358 participants
Conditions and interventions
Conditions
Interventions
- Alpelisib Drug
- Olaparib Drug
- Paclitaxel Drug
- Pegylated liposomal doxorubicin (PLD) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 22, 2021 (Actual)
- Primary completion
- Apr 21, 2023 (Actual)
- Completion
- Jan 19, 2026 (Actual)
- Last update posted
- Oct 19, 2026
2021 – 2026
United States locations
- U.S. sites
- 16
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Oncology Associates | Phoenix | Arizona | 85016 | — |
| HonorHealth | Phoenix | Arizona | 85016 | — |
| Florida Cancer Specialists | Fort Myers | Florida | 33901 | — |
| Florida Cancer Specialists | West Palm Beach | Florida | 33401 | — |
| Maryland Oncology Hematology P A | Silver Spring | Maryland | 20904 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Memorial Sloan Kettering Cancer Ctr | New York | New York | 10065 | — |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45242 | — |
| University Of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57106 | — |
| Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Texas Oncology | Amarillo | Texas | 79124 | — |
| Texas Oncology P A | Bedford | Texas | 76022 | — |
| Texas Oncology P A | San Antonio | Texas | 78217 | — |
| Texas Oncology Northeast Texas | Tyler | Texas | 75702 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 77 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04729387, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 19, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04729387 live on ClinicalTrials.gov.