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NCT00111007 · ClinicalTrials.gov registry record · Phase 3
A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 270
- Enrollment target
NCT00111007 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 270 participants.
The verdict
NCT00111007, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 270 participants
- Enrollment target
Study Summary
The objectives of this study are to compare the anti-tumor activity as measured by Progression Free Survival (PFS) and tolerability of Sorafenib in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who progressed after receiving only one prior therapy containing Dacarbazine (DTIC) or Temozolomide (TMZ).
Interventions
- DRUG Placebo
- DRUG Sorafenib (Nexavar, BAY43-9006)
- DRUG Carboplatin/Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2005-05 |
| Est. Completion | 2009-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00111007
The ClinicalTrials.gov registry entry for NCT00111007 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 270 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00111007 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00111007 about?
NCT00111007 is a clinical study titled "A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma". The objectives of this study are to compare the anti-tumor activity as measured by Progression Free Survival (PFS) and tolerability of Sorafenib in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects with unresectable Stage III or Sta...
What is the current status of trial NCT00111007?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 270 participants. The study started on 2005-05. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00111007?
The interventions under investigation include: Placebo (DRUG), Sorafenib (Nexavar, BAY43-9006) (DRUG), Carboplatin/Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT00111007?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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