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NCT01667419 · ClinicalTrials.gov registry record · Phase 3
A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma
A Phase 3 study of Melanoma, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 498
- Enrollment target
- 20
- Study locations
NCT01667419 is a Phase 3 study of Melanoma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 498 participants, below the 705-participant average among 266 other Melanoma trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 2 states.
The verdict
NCT01667419, a Phase 3 study of Melanoma, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 498 participants
- Enrollment target
- 20
- Study locations
Study Summary
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than \[\>\] 1 millimeter \[mm\] in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Vemurafenib
Study Locations (20)
California
- UCLA Department of Medicine; Division of Hematology / Oncology - California City
- Kaiser Permanente - Hayward - Hayward
- UCLA Hematology Oncology - Irvine - Irvine
- UCSD Moores Cancer Center - La Jolla
- The Angeles Clinic and Research Institute - W LA Office - Los Angeles
- Cancer Center Of Santa Barbara; Network Clinical Research Specialist - Los Angeles
- TRIO-US Network Administration; Network Clinical Research Specialist - Los Angeles
- Kaiser Foundation Hospital - Oakland (W. MacArthur) - Oakland
- Kaiser Permanente - Oakland - Oakland
- UCLA Healthcare/Pasadena Oncology - Pasadena
- Kaiser Permanente - Roseville - Roseville
- Kaiser Permanente Sacramento Medical Center - Sacramento
- Kaiser Permanente - San Francisco
- K. Permanente - San Jose - San Jose
- Coastal Integrative Cancer Care - San Luis Obispo
- Kaiser Permanente - Santa Clara - Santa Clara
- Kaiser Permanente - South San Francisco - South San Francisco
- Stanford University School of Medicine; Stanford Hospital Pharmacy - Stanford
- UCLA Cancer Center Hema/Oncol - Valencia
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 498 participants |
| Start Date | 2012-09-24 |
| Est. Completion | 2018-07-13 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01667419
The ClinicalTrials.gov registry entry for NCT01667419 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 498 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 705-participant average among 266 other Melanoma trials with a reported enrollment target (29% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01667419 reports 20 study locations spanning 2 distinct geographic areas - top geographies include California, Alabama.
Frequently Asked Questions
What is clinical trial NCT01667419 about?
NCT01667419 is a clinical study titled "A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma". This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 w...
What is the current status of trial NCT01667419?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 498 participants. The study started on 2012-09-24. Estimated completion is 2018-07-13.
What conditions does trial NCT01667419 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT01667419?
The interventions under investigation include: Placebo (DRUG), Vemurafenib (DRUG).
Who is sponsoring clinical trial NCT01667419?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01667419 being conducted?
This trial has 20 study locations across Alabama, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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