A Study to Investigate the Effect of Itraconazole and Rifampin on Pharmacokinetics (PK) of Vemurafenib at Steady State
Completed · Phase 1
Conditions studied: Metastatic Melanoma, BRAF V600 Mutation Positive
In brief
This is a two-part, Phase 1, open-label, multicenter, two-period, one-sequence study to investigate the effect of itraconazole and rifampin on the PK of vemurafenib following multiple 960 milligrams (mg) twice daily (BID) dosing in adult participants with unresectable Stage IIIC or Stage IV metastatic melanoma positive for the BRAF V600 mutation, or other malignant tumor types that harbor a V600-activating mutation of BRAF where the participant has no acceptable standard treatment options.
Key facts
- Study ID
- NCT02608034
- Run by
- Genentech, Inc.
- People needed
- 32
- Starts
- 2016-05-26
- Expected to finish
- 2018-09-10
- Last updated by the study team
- 2020-02-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants with age greater than or equal to (>=) 18 years with either unresectable Stage IIIC or Stage IV metastatic melanoma positive for the BRAF V600 mutation, or other malignant tumor types that harbor a V600-activating mutation of BRAF
- Eastern Cooperative Oncology Group Performance Status 0 to 2
- Life expectancy >=12 weeks
- Adequate hematologic and end organ function obtained within 2 weeks prior to first dose of study drug
- Female participants of childbearing potential and male participants with partners of childbearing potential must agree to always use two effective methods of contraception including at least one method with a failure rate of <1% per year during the course of the study and for at least 6 months after completion of study treatment
- Negative serum pregnancy test within 7 days prior to commencement of dosing in women of childbearing potential
- Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
You may not qualify if…
- Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of Study Day 1 of Period A
- Allergy or hypersensitivity to components of the vemurafenib formulation
- Experimental therapy within 4 weeks prior to first dose of study drug treatment on Study Day 1 of Period A
- Major surgical procedure or significant traumatic injury within 14 days prior to first dose of study drug treatment on Study Day 1 of Period A, or anticipation of the need for major surgery during study treatment
- Prior anti-cancer therapy (e.g., biologic or other targeted therapy, chemotherapy) within 28 days (6 weeks for nitrosoureas or mitomycin C, and 14 days for hormonal therapy or kinase inhibitors) before the first dose of study treatment on Study Day 1 of Period A.
Where it is running
- Mary Crowley Medical Research Center — Dallas, Texas, United States
- Rambam Health Care Campus; Oncology — Haifa, Israel
- Hadassah Ein Karem Hospital; Oncology Dept — Jerusalem, Israel
- Tel Aviv Sourasky Medical Center; Pharmacy — Tel Aviv, Israel
- Republican Clinical Oncologic Dispensary of Republic Of Tatarstan — Kazan', Russia
- FSBSI "N. N. Blokhin Russian Cancer Research Center" — Moscow, Russia
- St. Petersburg Oncology Hospital — Saint Petersburg, Russia
- Seoul National University Hospital — Seoul, South Korea
- Samsung Medical Center; Gastroenterology — Seoul, South Korea
- Asan Medical Center; Division of Oncology — Seoul, South Korea
- Severance Hospital - Yonsei Uni ; Obstetrics & Gynaecology Dept. — Seoul, South Korea
Full record on ClinicalTrials.gov
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