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NCT02580058 · ClinicalTrials.gov registry record · Phase 3
A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)
A Phase 3 study of Ovarian Cancer, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 566
- Enrollment target
- 20
- Study locations
NCT02580058: Completed Phase 3 study of Ovarian Cancer, sponsored by Pfizer.
NCT02580058 is a Phase 3 study of Ovarian Cancer that has completed, run by Pfizer. The registered enrollment target is 566 participants, below the 727-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02580058, a Phase 3 study of Ovarian Cancer, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 566 participants
- Enrollment target
- 20
- Study locations
Study Summary
A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.
Primary Outcome
OS is defined as the time from the date of randomization to the date of death due to any cause. OS time was summarized by treatment arm using the Kaplan-Meier method.
Conditions Studied
Interventions
- DRUG PLD
- BIOLOGICAL avelumab
Study Locations (20)
Arizona
- Arizona Oncology Associates, PC - HAL - Chandler
- Arizona Oncology Associates, PC - HAL - Phoenix
- Arizona Oncology Associates, PC - HAL - Phoenix
- Arizona Oncology Associates, PC - HAL - Scottsdale
- Arizona Oncology Associates, PC-HAL - Tempe
- Arizona Oncology Associates, PC - HOPE - Tucson
- Arizona Oncology Associates, PC - HOPE - Tucson
California
- University of California, Irvine/UC Irvine Health - Orange
- Sansum Clinic - Santa Barbara
- Sansum Clinic - Solvang
Colorado
- Rocky Mountain Cancer Centers - Aurora
- Rocky Mountain Cancer Centers - Boulder
- Rocky Mountain Cancer Centers - Lakewood
Florida
- Florida Cancer Specialists - Daytona Beach
- Florida Cancer Specialists - Wellington
- Florida Cancer Specialists - West Palm Beach
Arkansas
- Highlands Oncology Group - Fayetteville
- Highlands Oncology Group - Rogers
Georgia
- Atlanta Gynecologic Oncology - Atlanta
- Northside Hospital - Pharmacy - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 566 participants |
| Start Date | 2015-12-21 |
| Est. Completion | 2022-07-12 |
| Phase | Phase 3 |
What the finished NCT02580058 record still lists
NCT02580058 is an interventional study that assigns participants to a tested intervention. The registered 566 participants enrollment target is mid-sized for trials with a published cap, below the 727-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions - of which PLD is the first listed.
NCT02580058 names 20 study sites across 6 states, led by Arizona, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT02580058 about?
NCT02580058 is a clinical study titled "A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)". A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.
What is the current status of trial NCT02580058?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 566 participants. The study started on 2015-12-21. Estimated completion is 2022-07-12.
What conditions does trial NCT02580058 study?
This clinical trial studies the following conditions: Ovarian Cancer.
What interventions are being tested in trial NCT02580058?
The interventions under investigation include: PLD (DRUG), avelumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02580058?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02580058 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ovarian Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02580058's enrollment target sits among peer trials
566 41st of 322 higher than 281 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer 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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