A Pharmacokinetics (PK) Study to Investigate the Effect of Rifampin on PK of Vemurafenib (Zelboraf)

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Rifampin; Vemurafenib

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