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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01739764
First received: November 26, 2012
Last updated: March 10, 2017
Last verified: March 2017
  Purpose
This open-label, multicenter, non-randomized study will provide 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 are treated beyond progression and are still deriving clinical benefit (as assessed by investigator), and may therefore potentially benefit from continued treatment with vemurafenib. Participants will receive 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 will continue until progression of disease or as long as the participant is 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 occurs first.

Condition Intervention Phase
Neoplasms
Drug: Vemurafenib
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: An Open-Label, Extension (Rollover) Study of Vemurafenib in Patients With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Continued Access to Vemurafenib [ Time Frame: Baseline up to approximately 6 years ]

Secondary Outcome Measures:
  • Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to approximately 6 years ]

Estimated Enrollment: 450
Actual Study Start Date: February 28, 2013
Estimated Study Completion Date: February 28, 2019
Estimated Primary Completion Date: February 28, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Vemurafenib
Participants will receive oral vemurafenib at 960 mg BID, 720 mg BID, or 480 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
Drug: Vemurafenib
Vemurafenib will be given based on the last dose of the antecedent study (minimum 480 mg orally BID).
Other Name: Zelboraf

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BRAF V600 mutation-positive malignancy
  • Prior eligibility for and on study treatment from an antecedent vemurafenib protocol
  • Ability to begin treatment in the extension (rollover) protocol within 15 days following the last day of the study in the antecedent protocol
  • Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use 2 adequate methods of contraception as defined by protocol during the course of this study and for at least 6 months after completion of study treatment

Exclusion Criteria:

  • Adverse event requiring discontinuation of vemurafenib in the antecedent protocol
  • Progressive disease during the antecedent protocol. If approval to treat beyond progression was already given in the antecedent protocol, the participant may roll over into the current protocol without sponsor approval. Under special circumstances, enrollment into this protocol and dosing beyond progression may be considered and will require approval of the sponsor

Participants meeting any of the following exclusion criterion of the antecedent study at the time the participant is considered for the extension (rollover) study:

  • Current, recent (within 28 days prior to Day 1), or planned use of any antitumor therapy outside this study
  • Any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the participant or compromise the participant's ability to participate in the study
  • History of malabsorption or other clinically significant metabolic dysfunction
  • History of clinically significant cardiac or pulmonary dysfunction as specified in antecedent study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739764

Contacts
Contact: Reference Study ID Number: GO28399 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Show 171 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01739764     History of Changes
Other Study ID Numbers: GO28399
2012-003144-80 ( EudraCT Number )
Study First Received: November 26, 2012
Last Updated: March 10, 2017

ClinicalTrials.gov processed this record on March 23, 2017