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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Itraconazole will be administered as a 200 mg oral solution QD during Part 1 only for 20 consecutive days.
Rifampin will be administered as a 600 mg oral solution QD during Part 2 only for 20 consecutive days.
Vemurafenib will be administered in both Part 1 and Part 2 at a dose of 960 mg BID for at least 40 conseutive days.
Mary Crowley Medical Research Center
Dallas, Texas, United States
Rambam Health Care Campus; Oncology
Haifa, Israel
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, Israel
Area under the concentration-time curve From Time 0 to 12 Hours Postdose (AUC0-12)
Time frame: Period A and B: Pre-morning dose on Day 18, 19, and 20 and 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose on Day 20
Maximum observed concentration (Cmax)
Time frame: Period A and B: Pre-morning dose on Day 18, 19, and 20 and 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose on Day 20
Time to maximum concentration (Tmax)
Time frame: Period A and B: Pre-morning dose on Day 18, 19, and 20 and 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose on Day 20
Incidence of adverse events
Time frame: 28 days after last dose of study treatment (last dose = Day 40)
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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
...and 1 more locations