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NCT01343277 · ClinicalTrials.gov registry record · Phase 3
A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma
A Phase 3 study of Advanced Liposarcoma or Leiomyosarcoma, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 579
- Enrollment target
- 20
- Study locations
NCT01343277: Completed Phase 3 study of Advanced Liposarcoma or Leiomyosarcoma, sponsored by Janssen Research & Development.
NCT01343277 is a Phase 3 study of Advanced Liposarcoma or Leiomyosarcoma that has completed, run by Janssen Research & Development. The registered enrollment target is 579 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01343277, a Phase 3 study of Advanced Liposarcoma or Leiomyosarcoma, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 579 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate whether overall survival for the trabectedin group is superior to the dacarbazine group for patients with advanced L-sarcoma (liposarcoma or leiomyosarcoma).
Primary Outcome
The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.
Conditions Studied
Interventions
- DRUG Dacarbazine
- DRUG Trabectedin
Study Locations (20)
California
- - La Jolla
- - Los Angeles
- - San Diego
- - San Francisco
- - Santa Monica
Florida
- - Boynton Beach
- - Hollywood
- - Miami
- - Orlando
- - Tampa
Georgia
- - Atlanta
- - Augusta
- - Savannah
Arizona
- - Phoenix
- - Tucson
Colorado
- - Aurora
- - Denver
Connecticut
- - Hartford
- - New Haven
Arkansas
- - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 579 participants |
| Start Date | 2011-06 |
| Est. Completion | 2016-04 |
| Phase | Phase 3 |
What the finished NCT01343277 record still lists
NCT01343277 is an interventional study that assigns participants to a tested intervention. The registered 579 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower).
The record links to 1 condition, with Advanced Liposarcoma or Leiomyosarcoma appearing as the primary indexed condition, and to 2 interventions - of which Dacarbazine is the first listed.
NCT01343277 names 20 study sites across 7 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01343277 about?
NCT01343277 is a clinical study titled "A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma". The purpose of this study is to evaluate whether overall survival for the trabectedin group is superior to the dacarbazine group for patients with advanced L-sarcoma (liposarcoma or leiomyosarcoma).
What is the current status of trial NCT01343277?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 579 participants. The study started on 2011-06. Estimated completion is 2016-04.
What conditions does trial NCT01343277 study?
This clinical trial studies the following conditions: Advanced Liposarcoma or Leiomyosarcoma.
What interventions are being tested in trial NCT01343277?
The interventions under investigation include: Dacarbazine (DRUG), Trabectedin (DRUG).
Who is sponsoring clinical trial NCT01343277?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01343277 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01343277's enrollment target sits among peer trials
579 659th of 2000 higher than 1,340 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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