A Pharmacokinetics (PK) Study to Investigate the Effect of Rifampin on PK of Vemurafenib (Zelboraf)
Completed · Phase 1
Conditions studied: Malignant Melanoma, Neoplasms
In brief
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).
Key facts
- Study ID
- NCT01765543
- Run by
- Hoffmann-La Roche
- People needed
- 27
- Starts
- 2013-07-01
- Expected to finish
- 2015-11-01
- Last updated by the study team
- 2016-12-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Rogers, Arkansas, United States
- Study site — Pleasant Hill, California, United States
- Study site — Middletown, Ohio, United States
- Study site — Dallas, Texas, United States
- Study site — Porto Alegre, Rio Grande do Sul, Brazil
- Study site — Porto Alegre, Rio Grande do Sul, Brazil
- Study site — Porto Alegre, Rio Grande do Sul, Brazil
- Study site — Varaždin, Croatia
- Study site — Zagreb, Croatia
- Study site — Alexandria, Egypt
- Study site — Cairo, Egypt
- Study site — Dakahlia, Egypt
- Study site — Tanta, Egypt
- Study site — Cape Town, South Africa
- Study site — Port Elizabeth, South Africa
Full record on ClinicalTrials.gov
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