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NCT01846611 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
A Phase 3 study of Ovarian Neoplasms and Peritoneal Neoplasms, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 581
- Enrollment target
- 20
- Study locations
NCT01846611: Completed Phase 3 study of Ovarian Neoplasms and Peritoneal Neoplasms, sponsored by Janssen Research & Development.
NCT01846611 is a Phase 3 study of Ovarian Neoplasms and Peritoneal Neoplasms that has completed, run by Janssen Research & Development. The registered enrollment target is 581 participants, above the 353-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (65% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01846611, a Phase 3 study of Ovarian Neoplasms and Peritoneal Neoplasms, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 581 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the efficacy and safety of trabectedin+DOXIL as a third-line chemotherapy regimen (treatment) in patients with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who received 2 previous lines of platinum-based chemotherapy.
Primary Outcome
OS is defined as the time between the date of randomization and the date of death. Participants who died, regardless of the cause of death, were considered to have had an event.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Trabectedin
- DRUG DOXIL
Study Locations (20)
California
- - Greenbrae
- - La Jolla
- - Los Angeles
- - Orange
- - Sacramento
Florida
- - Fort Myers
- - Jacksonville
- - Miami
- - Sarasota
- - St. Petersburg
Arizona
- - Phoenix
- - Scottsdale
- - Sedona
- - Tucson
Connecticut
- - New Britain
- - New Haven
- - Stamford
Alabama
- - Birmingham
Arkansas
- - Hot Springs
Colorado
- - Englewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 581 participants |
| Start Date | 2013-10-16 |
| Est. Completion | 2018-11-16 |
| Phase | Phase 3 |
What the finished NCT01846611 record still lists
NCT01846611 is an interventional study that assigns participants to a tested intervention. The registered 581 participants enrollment target is mid-sized for trials with a published cap, above the 353-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (65% higher).
The record links to 3 conditions, with Ovarian Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Dexamethasone is the first listed.
NCT01846611 names 20 study sites across 7 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT01846611 about?
NCT01846611 is a clinical study titled "A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer". The purpose of this study is to assess the efficacy and safety of trabectedin+DOXIL as a third-line chemotherapy regimen (treatment) in patients with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who received 2 previous lines of platinum-based ...
What is the current status of trial NCT01846611?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 581 participants. The study started on 2013-10-16. Estimated completion is 2018-11-16.
What conditions does trial NCT01846611 study?
This clinical trial studies the following conditions: Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms.
What interventions are being tested in trial NCT01846611?
The interventions under investigation include: Dexamethasone (DRUG), Trabectedin (DRUG), DOXIL (DRUG).
Who is sponsoring clinical trial NCT01846611?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01846611 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01846611's enrollment target sits among peer trials
581 11th of 38 higher than 28 of 38 other Ovarian Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Neoplasms 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Randomized Trial for Patients With Platinum Resistant Ovarian, Fallopian or Primary Peritoneal Cancer.
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