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NCT06580314 · ClinicalTrials.gov registry record · Phase 3
Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer
A Phase 3 study of Ovarian Carcinoma and Fallopian Tube Endometrioid Adenocarcinoma, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 880
- Enrollment target
- 20
- Study locations
NCT06580314: Recruiting Phase 3 study of Ovarian Carcinoma and Fallopian Tube Endometrioid Adenocarcinoma, sponsored by NRG Oncology.
NCT06580314 is a Phase 3 study of Ovarian Carcinoma and Fallopian Tube Endometrioid Adenocarcinoma that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 880 participants, below the 3,219-participant average among 35 other Ovarian Carcinoma trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06580314, a Phase 3 study of Ovarian Carcinoma and Fallopian Tube Endometrioid Adenocarcinoma, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 880 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- DRUG Olaparib
- BIOLOGICAL Bevacizumab
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Arkansas
- Highlands Oncology Group - Fayetteville - Fayetteville
- Mercy Hospital Fort Smith - Fort Smith
- CARTI Cancer Center - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
- Highlands Oncology Group - Rogers - Rogers
- Highlands Oncology Group - Springdale
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Kaiser Permanente-Bellflower - Bellflower
Arizona
- Cancer Center at Saint Joseph's - Phoenix
- Mayo Clinic Hospital in Arizona - Phoenix
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 880 participants |
| Start Date | 2025-03-12 |
| Est. Completion | 2034-12-31 |
| Phase | Phase 3 |
What NCT06580314 shows while recruiting
NCT06580314 is an interventional study that assigns participants to a tested intervention. The registered 880 participants enrollment target is mid-sized for trials with a published cap, below the 3,219-participant average among 35 other Ovarian Carcinoma trials with a reported enrollment target (73% lower).
The record links to 9 conditions, with Ovarian Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06580314 names 20 study sites across 5 states, led by Alaska, Arkansas, California.
Frequently Asked Questions
What is clinical trial NCT06580314 about?
NCT06580314 is a clinical study titled "Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer". 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 inhibit...
What is the current status of trial NCT06580314?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 880 participants. The study started on 2025-03-12. Estimated completion is 2034-12-31.
What conditions does trial NCT06580314 study?
This clinical trial studies the following conditions: Ovarian Carcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma, Fallopian Tube High Grade Serous Adenocarcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma.
What interventions are being tested in trial NCT06580314?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Olaparib (DRUG), Bevacizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT06580314?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06580314 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06580314's enrollment target sits among peer trials
880 6th of 35 higher than 30 of 35 other Ovarian Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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