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NCT01524978 · ClinicalTrials.gov registry record · Phase 2
A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers
A Phase 2 study of Multiple Myeloma, Neoplasms, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 208
- Enrollment target
- 20
- Study locations
NCT01524978: Completed Phase 2 study of Multiple Myeloma, Neoplasms, sponsored by Hoffmann-La Roche.
NCT01524978 is a Phase 2 study of Multiple Myeloma, Neoplasms that has completed, run by Hoffmann-La Roche. The registered enrollment target is 208 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01524978, a Phase 2 study of Multiple Myeloma, Neoplasms, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 208 participants
- Enrollment target
- 20
- Study locations
Study Summary
This open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best treatment option in the opinion of the investigator. Participants will receive twice daily oral doses of 960 mg vemurafenib until disease progression, unacceptable toxicity, or withdrawal of consent. The safety and efficacy of vemurafenib in combination with cetuximab in a subset of participants with colorectal cancer will also be assessed.
Primary Outcome
Confirmed BORR: percentage of participants with an objective response (OR) (complete response \[CR\], partial response \[PR\], stringent CR \[sCR\] or very good PR \[VGPR\]) on 2 occasions \>/= 4 weeks apart as assessed by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. or International Myeloma Working Group (IMWG) criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: \>/= 30% decrease in the sum of diameters of target lesions. IMWG: CR: negative
Conditions Studied
Interventions
- DRUG cetuximab
- DRUG vemurafenib
Study Locations (20)
Other
- Tianjin Cancer Hospital - Tianjin
- Institut Bergonie; Oncologie - Bordeaux
- Centre Francois Baclesse; Oncologie - Caen
- Centre Georges François Leclerc - Dijon
- Centre Leon Berard; Departement Oncologie Medicale - Lyon
- Institut Paoli-Calmettes; Oncologie Medicale 1 - Marseille
- Centre Rene Gauducheau - Saint-Herblain
- Institut Claudius Regaud; Departement Oncologie Medicale - Toulouse
- Institut Gustave Roussy; Sitep - Villejuif
Massachusetts
- Massachusetts General Hospital;Oncology - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
Arizona
- Arizona Oncology - Tucson
Colorado
- Rocky Mountain Cancer Centers, LLP - Aurora
Michigan
- Karmanos Cancer Institute - Detroit
Missouri
- Washington University - St Louis
New York
- Memorial Sloan-Kettering Cancer Center - New York
Tennessee
- Vanderbilt - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2012-04-12 |
| Est. Completion | 2016-10-28 |
| Phase | Phase 2 |
What the finished NCT01524978 record still lists
NCT01524978 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% higher).
The record links to 1 condition, with Multiple Myeloma, Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which cetuximab is the first listed.
NCT01524978 names 20 study sites across 10 states, led by Other, Massachusetts, Arizona.
Frequently Asked Questions
What is clinical trial NCT01524978 about?
NCT01524978 is a clinical study titled "A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers". This open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best treatment option in the opinio...
What is the current status of trial NCT01524978?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 208 participants. The study started on 2012-04-12. Estimated completion is 2016-10-28.
What conditions does trial NCT01524978 study?
This clinical trial studies the following conditions: Multiple Myeloma, Neoplasms.
What interventions are being tested in trial NCT01524978?
The interventions under investigation include: cetuximab (DRUG), vemurafenib (DRUG).
Who is sponsoring clinical trial NCT01524978?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01524978 being conducted?
This trial has 20 study locations across Arizona, Colorado, Massachusetts, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01524978's enrollment target sits among peer trials
208 294th of 2000 higher than 1,704 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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