A Pharmacokinetics (PK) Study to Investigate the Effect of Rifampin on PK of Vemurafenib (Zelboraf)
Condition: Malignant Melanoma, Neoplasms
MeSH terms: Melanoma
Intervention: Rifampin; Vemurafenib
Intervention description: Rifampin at a dose of 600 mg as capsules orally once daily will be administered from Days 8 through 23 (Periods B and C).; Participants, after an overnight fast of at least 10 hours, will receive vemurafenib at a dose of 960 mg as film-coated tablets orally on Day 1 (Period A) and on Day 17 (Period C).
Intervention MeSH terms: Rifampin; Vemurafenib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, multi-center, three-period, one-sequence study will investigate the effect
      of rifampin on the PK of vemurafenib in participants with unresectable BRAFV600-mutation
      positive metastatic melanoma or other malignant tumor type that harbors a V600-activating
      mutation of BRAF without acceptable standard treatment options. Eligible participants will
      have the option to continue treatment with vemurafenib as part of an extension study GO28399
      (NCT01739764).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with either unresectable Stage IIIc or Stage IV metastatic melanoma
             positive for the BRAF V600 mutation or other malignant tumor type that harbors a
             V600-activating mutation of BRAF, as determined by results of cobas® 4800 BRAF V600
             mutation test or a Deoxyribonucleic acid (DNA) sequencing method, and who have no
             acceptable standard treatment options

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

          -  Life expectancy of greater than or equal to (>/=) 12 weeks

          -  Full recovery from the effects of any major surgery or significant traumatic injury
             within 14 days prior to the first dose of study treatment

          -  Adequate hematologic and end organ function

          -  Female participants of childbearing potential and male participants with partners of
             childbearing potential must agree to always use 2 effective methods of contraception

          -  Negative serum pregnancy test within 7 days prior to commencement of dosing in women
             of childbearing potential

        Exclusion Criteria:

          -  Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of first dose
             of study drug

          -  Requirement for immediate or urgent treatment with daily vemurafenib and for whom the
             intermittent schedule of vemurafenib employed during the 24-day period for this trial
             is not clinically acceptable

          -  Allergy or hypersensitivity to components of the vemurafenib formulation

          -  Experimental therapy within 4 weeks prior to first dose of study drug

          -  Major surgical procedure or significant traumatic injury within 14 days prior to first
             dose of study drug, or anticipation of the need for major surgery during study
             treatment

          -  Prior anti-cancer therapy within 28 days before the first dose of study drug

          -  History of clinically significant cardiac or pulmonary dysfunction

          -  History of symptomatic congestive heart failure of any New York Heart Association
             class or serious cardiac arrhythmia requiring treatment

          -  History of myocardial infarction within 6 months prior to first dose of study drug

          -  Current dyspnea at rest, owing to complications of advanced malignancy or any
             requirement for supplemental oxygen to perform activities of daily living

          -  History of congenital long QT syndrome or corrected QT interval (QTc) greater than (>)
             450 milliseconds

          -  Active central nervous system lesions

          -  Uncontrolled or poorly controlled diabetes

          -  Current severe, uncontrolled systemic disease