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Completed Phase 2 Interventional Results available

A Study of Vemurafenib in Metastatic Melanoma Participants With Brain Metastases

ClinicalTrials.gov ID: NCT01378975

Public ClinicalTrials.gov record NCT01378975. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 12:16 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-label, Single-arm, Phase II, Multicenter Study, to Evaluate the Efficacy of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This open-label, single-arm, multicenter study will evaluate the efficacy and safety in participants with metastatic melanoma who developed brain metastases. Participants may or may not have received prior systemic treatment for metastatic melanoma \[except treatment with v-raf murine sarcoma viral oncogene homolog B (BRAF) or mitogen-activated protein kinase (MEK) inhibitors\]. Participants will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal.

Study identification

NCT ID
NCT01378975
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
146 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2011
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015
Last update posted
Jun 24, 2025

2011 – 2015

United States locations

U.S. sites
11
U.S. states
10
U.S. cities
10
Facility City State ZIP Site status
Not listed Los Angeles California 90025
Not listed Aurora Colorado 80045
Not listed Tampa Florida 33612-9497
Not listed Boston Massachusetts 02114
Not listed Boston Massachusetts 02215
Not listed Detroit Michigan 48201
Not listed Rochester Minnesota 55905
Not listed St Louis Missouri 63110
Not listed Charlotte North Carolina 28204-2839
Not listed Dallas Texas 75246
Not listed Seattle Washington 98195

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01378975, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 24, 2025 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01378975 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →