Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Bevacizumab: Given IV
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Study summary
This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib for one year with or without bevacizumab may be effective in treating patients with BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer, when compared to two years of olaparib.
Eligibility
Primary outcome measure(s)
- Progression free survival (PFS) at least 360 days after randomization (PFS360) — From completing 360 days of maintenance therapy to disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1) or death, whichever occurs first, assessed up to 5 years
PFS will be tested using a one-sided, alpha = 0.05 level logrank test. Treatment hazard ratios and their 90% confidence intervals will be estimated using a Cox proportional hazards model specified with a main effect for the randomized treatment assignment and stratified using the stratification factors applied at randomization.
Trial sites (695)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | Recruiting |
| Anchorage Associates in Radiation Medicine | Anchorage | Alaska | Recruiting |
| Alaska Breast Care and Surgery LLC | Anchorage | Alaska | Recruiting |
| Alaska Oncology and Hematology LLC | Anchorage | Alaska | Recruiting |
| Alaska Women's Cancer Care | Anchorage | Alaska | Recruiting |
| Katmai Oncology Group | Anchorage | Alaska | Recruiting |
| Providence Alaska Medical Center | Anchorage | Alaska | Recruiting |
| Fairbanks Memorial Hospital | Fairbanks | Alaska | Recruiting |
| Cancer Center at Saint Joseph's | Phoenix | Arizona | Recruiting |
| Mayo Clinic Hospital in Arizona | Phoenix | Arizona | Recruiting |
| Highlands Oncology Group - Fayetteville | Fayetteville | Arkansas | Recruiting |
| Mercy Hospital Fort Smith | Fort Smith | Arkansas | Recruiting |
| CARTI Cancer Center | Little Rock | Arkansas | Recruiting |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | Recruiting |
| Highlands Oncology Group - Rogers | Rogers | Arkansas | Recruiting |
| Highlands Oncology Group | Springdale | Arkansas | Recruiting |
| Kaiser Permanente-Deer Valley Medical Center | Antioch | California | Recruiting |
| Mission Hope Medical Oncology - Arroyo Grande | Arroyo Grande | California | Recruiting |
| Sutter Auburn Faith Hospital | Auburn | California | Recruiting |
| Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California | Recruiting |
| Kaiser Permanente-Bellflower | Bellflower | California | Recruiting |
| Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California | Recruiting |
| Tower Cancer Research Foundation | Beverly Hills | California | Active Not Recruiting |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | Recruiting |
| Mills-Peninsula Medical Center | Burlingame | California | Recruiting |
| Sutter Cancer Centers Radiation Oncology Services-Cameron Park | Cameron Park | California | Recruiting |
| Mercy Cancer Center - Carmichael | Carmichael | California | Recruiting |
| Mercy San Juan Medical Center | Carmichael | California | Recruiting |
| Eden Hospital Medical Center | Castro Valley | California | Recruiting |
| Sutter Davis Hospital | Davis | California | Recruiting |
| Kaiser Permanente Dublin | Dublin | California | Recruiting |
| Mercy Cancer Center - Elk Grove | Elk Grove | California | Recruiting |
| Stanford Cancer Center Emeryville | Emeryville | California | Recruiting |
| Kaiser Permanente-Fremont | Fremont | California | Recruiting |
| Palo Alto Medical Foundation-Fremont | Fremont | California | Recruiting |
| Fresno Cancer Center | Fresno | California | Recruiting |
| Kaiser Permanente Fresno Orchard Plaza | Fresno | California | Recruiting |
| Kaiser Permanente-Fresno | Fresno | California | Recruiting |
| Kaiser Permanente South Bay | Harbor City | California | Recruiting |
| Kaiser Permanente-Irvine | Irvine | California | Recruiting |
+ 655 more sites — see the full list on the official registry below.
More NRG Oncology trials in Mexico
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06580314 on ClinicalTrials.gov ↗ ← All trials in Mexico