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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 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 452 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01327885
The ClinicalTrials.gov registry entry for NCT01327885 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 452 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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