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NCT01227889 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 251
- Enrollment target
NCT01227889 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 251 participants.
The verdict
NCT01227889, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 251 participants
- Enrollment target
Study Summary
BRF113683 is a Phase III, randomized, open-label study comparing the efficacy, safety, and tolerability of GSK2118436 to dacarbazine (DTIC), in subjects with BRAF mutant advanced (Stage III) or metastatic (Stage IV) melanoma. Subjects will be randomized to receive 150 mg of GSK2118436 twice daily or 1000 mg/m2 DTIC every 3 weeks and continue on treatment until disease progression, death, or unacceptable adverse event. Subjects who progress on DTIC will be allowed to crossover to an optional extension arm of the study to receive GSK2118436.
Interventions
- DRUG GSK2118436
- DRUG Dacarbazine (DTIC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 251 participants |
| Start Date | 2010-12-23 |
| Est. Completion | 2016-09-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01227889
The ClinicalTrials.gov registry entry for NCT01227889 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 251 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which GSK2118436 is the first listed.
NCT01227889 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01227889 about?
NCT01227889 is a clinical study titled "A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma". BRF113683 is a Phase III, randomized, open-label study comparing the efficacy, safety, and tolerability of GSK2118436 to dacarbazine (DTIC), in subjects with BRAF mutant advanced (Stage III) or metastatic (Stage IV) melanoma. Subjects will be randomized to receive 150 mg of GSK2118436 twice daily or...
What is the current status of trial NCT01227889?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 251 participants. The study started on 2010-12-23. Estimated completion is 2016-09-16.
What interventions are being tested in trial NCT01227889?
The interventions under investigation include: GSK2118436 (DRUG), Dacarbazine (DTIC) (DRUG).
Who is sponsoring clinical trial NCT01227889?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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