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COMPLETED Phase 1

A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma

NCT01271803 · View on ClinicalTrials.gov ↗

Study Summary

This open-label, dose-escalation study of vemurafenib in combination with cobimetinib will evaluate the safety, tolerability and pharmacokinetics in participants with BRAFV600 mutation-positive metastatic melanoma. Participants with previously untreated, BRAFV600E mutation-positive, locally advanced/unresectable or metastatic melanoma or those who have progressed on vemurafenib monotherapy immediately prior to enrolling in this trial are eligible. Participants will be assigned to different cohorts with escalating oral doses of vemurafenib and cobimetinib. This study consists of 2 stages, Stage 1 (Dose Escalation Stage \[DES\] and Cohort Expansion Stage \[CES\]) and the anticipated time on study treatment is until disease progression, unacceptable toxicity or any other discontinuation criterion is met.

Conditions Studied

Interventions

  • DRUG Cobimetinib
  • DRUG vemurafenib

Study Locations (10)

California

  • UCLA Department of Medicine — Los Angeles
  • University of California at San Francisco — San Francisco
  • The Angeles Clinic and Research Institute, Santa Monica Office — Santa Monica

Colorado

  • University of Colorado; Anschutz Cancer Pavilion — Aurora

Illinois

  • University of Chicago — Chicago

Indiana

  • Indiana University - Department of Medicine, Division of Gastroenterology/Hepatology — Indianapolis

Michigan

  • Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building — Detroit

New York

  • New York University Medical Center — New York

Tennessee

  • Vanderbilt University Medical Center — Nashville

Victoria

  • Peter Maccallum Cancer Institute; Medical Oncology — Melbourne

Trial Details

FieldValue
Enrollment Target 131 participants
Start Date 2011-02-17
Est. Completion 2017-12-12
Phase Phase 1

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01271803

The ClinicalTrials.gov registry entry for NCT01271803 describes a study currently listed as completed. It is categorized as Phase 1, 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 131 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 Malignant Melanoma appearing as the primary indexed condition, and to 2 interventions — of which Cobimetinib 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: NCT01271803 reports 10 study locations spanning 8 distinct geographic areas — top geographies include California, Colorado, Illinois. 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 NCT01271803 about?

NCT01271803 is a clinical study titled "A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma". This open-label, dose-escalation study of vemurafenib in combination with cobimetinib will evaluate the safety, tolerability and pharmacokinetics in participants with BRAFV600 mutation-positive metastatic melanoma. Participants with previously untreated, BRAFV600E mutation-positive, locally advanced...

What is the current status of trial NCT01271803?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 131 participants. The study started on 2011-02-17. Estimated completion is 2017-12-12.

What conditions does trial NCT01271803 study?

This clinical trial studies the following conditions: Malignant Melanoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01271803?

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

Who is sponsoring clinical trial NCT01271803?

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 NCT01271803 being conducted?

This trial has 10 study locations across California, Colorado, Illinois, Indiana, Michigan. 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