An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol
Condition: Neoplasms
MeSH terms: Neoplasms
Intervention: Vemurafenib
Intervention description: Vemurafenib was given based on the last dose of the antecedent study (minimum 480 mg orally BID).
Intervention MeSH terms: Vemurafenib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 215.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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