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NCT01327885 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma
A Phase 3 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 3
- Development phase
- 452
- Enrollment target
NCT01327885: Completed Phase 3 study, sponsored by Eisai.
NCT01327885 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 452 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01327885, a Phase 3 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 452 participants
- Enrollment target
Study Summary
This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of eribulin with dacarbazine in subjects with advanced soft tissue sarcoma who have disease progression within 6 months prior to study enrolment following standard therapies which must have included an anthracycline, unless contraindicated and then at least one additional regimen after failure of the anthracycline.
Primary Outcome
OS was defined as the time in months from the date of treatment start until death, regardless of cause. In the absence of confirmation of death, participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. Participants who died on the date of randomization had a survival time of 0.5 day. Allocation of randomization numbers were performed based upon the following stratification factors: (a) Histology (adipocytic \[A
Interventions
- DRUG Eribulin mesylate 1.4 mg/m^2 intravenous
- DRUG Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 452 participants |
| Start Date | 2011-03-10 |
| Est. Completion | 2016-08-10 |
| Phase | Phase 3 |
What the finished NCT01327885 record still lists
NCT01327885 is an interventional study that assigns participants to a tested intervention. The registered 452 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 (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Eribulin mesylate 1.4 mg/m^2 intravenous is the first listed.
NCT01327885 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01327885 about?
NCT01327885 is a clinical study titled "Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma". This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of eribulin with dacarbazine in subjects with advanced soft tissue sarcoma who have disease progression within 6 months prior to study enrolment following standard therapies which must have included an ant...
What is the current status of trial NCT01327885?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 452 participants. The study started on 2011-03-10. Estimated completion is 2016-08-10.
What interventions are being tested in trial NCT01327885?
The interventions under investigation include: Eribulin mesylate 1.4 mg/m^2 intravenous (DRUG), Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IV (DRUG).
Who is sponsoring clinical trial NCT01327885?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01327885's enrollment target sits among peer trials
452 835th of 2000 higher than 1,165 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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