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NCT01245062 · ClinicalTrials.gov registry record · Phase 3
GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 322
- Enrollment target
NCT01245062 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 322 participants.
The verdict
NCT01245062, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 322 participants
- Enrollment target
Study Summary
This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample. Subjects who have received up to one prior regimen of chemotherapy in the advanced or metastatic melanoma setting will be enrolled into the study. Subjects with any prior BRAF or MEK inhibitor use will be excluded. Approximately 297 subjects will be enrolled with 2:1 randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy arm). The primary endpoint for the statistical analysis will be a comparison of progression free survival for subjects receiving GSK1120212 compared to chemotherapy. Subjects who have progression on chemotherapy will be offered the option to receive GSK1120212.
Interventions
- DRUG Chemotherapy
- DRUG GSK1120212
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 322 participants |
| Start Date | 2010-11-22 |
| Est. Completion | 2016-12-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01245062
The ClinicalTrials.gov registry entry for NCT01245062 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 322 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 Chemotherapy is the first listed.
NCT01245062 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01245062 about?
NCT01245062 is a clinical study titled "GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma". This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample. Subjects who have receiv...
What is the current status of trial NCT01245062?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 322 participants. The study started on 2010-11-22. Estimated completion is 2016-12-16.
What interventions are being tested in trial NCT01245062?
The interventions under investigation include: Chemotherapy (DRUG), GSK1120212 (DRUG).
Who is sponsoring clinical trial NCT01245062?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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