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An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol

NCT01739764 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2021-01-07

Study results available
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Summary

This open-label, multicenter, non-randomized study provided continued access to vemurafenib for eligible participants with BRAF V600 mutation-positive malignancy, who were previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the protocol's criteria for disease progression, or were treated beyond progression and were still deriving clinical benefit (as assessed by investigator), and may have therefore potentially benefited from continued treatment with vemurafenib. Participants received treatment with oral vemurafenib at 960 milligrams (mg) twice daily (BID), 720 mg BID, or 480 mg BID, depending on the last dose in the antecedent protocol. Treatment continued until progression of disease or as long as the participant was deriving clinical benefit, as judged by the investigator (case-by-case decision with approval of the Medical Monitor), death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the Sponsor to terminate the study, whichever occurred first.

Conditions

  • Neoplasms

Interventions

DRUG

Vemurafenib

Vemurafenib was given based on the last dose of the antecedent study (minimum 480 mg orally BID).

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-19
Primary Completion
2020-02-17
Completion
2020-02-17
FDA Drug
Yes

Countries

  • United States
  • Belarus
  • Belgium
  • Bosnia and Herzegovina
  • Brazil
  • Canada
  • Croatia
  • Cyprus
  • Egypt
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • New Zealand
  • Portugal
  • Romania
  • Russia
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01739764 on ClinicalTrials.gov