Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01739764
First received: November 26, 2012
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

This open-label, multicenter, non-randomized study will provide continued access to vemurafenib for eligible patients with BRAF V600 mutation-positive malignanc y, who were previously enrolled and treated in an antecedent vemurafenib protoco l and did not meet the protocol's criteria for disease progression, or are treat ed beyond progression and are still deriving clinical benefit (as assessed by in vestigator), and may therefore potentially benefit from continued treatment with vemurafenib. Patients will receive treatment with vemurafenib 960 mg orally twi ce daily or, if the dose was reduced in an antecedent protocol, the dose of the last visit of the antecedent study (minimum 480 mg orally twice daily). Treatmen t will continue until progression of disease or as long as the patient is derivi ng clinical benefit, as judged by the investigator, or until unacceptable toxici ty occurs.


Condition Intervention Phase
Neoplasms
Drug: vemurafenib
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IV, PostMarketing, 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:
  • To provide continued access to vemurafenib for eligible patients with BRAF mutation positive malignancy who were previously treated in an antecendent vemurafenib protocol and meet criteria for continuation of vemurafenib treatment [ Time Frame: up to approximately 5.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 5.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: February 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Vemurafenib Drug: vemurafenib
960 mg orally BID or, if the dose was reduced in an antecedent protocol, the dose of the last visit of the antecedent study (minimum 480 mg orally BID)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • 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 patients of childbearing potential and male patients with partners of childbearing potential must agree to use two 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 patient 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.

Patients meeting any of the following exclusion criterion of the antecedent study at the time the patient 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 patient or compromise the patient'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. Only) global.rochegenentechtrials@roche.com

  Show 60 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01739764     History of Changes
Other Study ID Numbers: GO28399, 2012-003144-80
Study First Received: November 26, 2012
Last Updated: November 24, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 27, 2014