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COMPLETED Phase 2

A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers

NCT01524978 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 208 participants
Start Date 2012-04-12
Est. Completion 2016-10-28
Phase Phase 2

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01524978

The ClinicalTrials.gov registry entry for NCT01524978 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 208 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01524978 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, Massachusetts, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01524978?

The interventions under investigation include: cetuximab (DRUG), vemurafenib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01524978?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial