Spots Global Cancer Trial Database for A Study to Investigate the Effect of Itraconazole and Rifampin on Pharmacokinetics (PK) of Vemurafenib at Steady State
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Trial Identification
Brief Title: A Study to Investigate the Effect of Itraconazole and Rifampin on Pharmacokinetics (PK) of Vemurafenib at Steady State
Official Title: A Two-part, Phase I, Open-label, Multicenter, Two-period, One-sequence Study to Investigate the Effect of Itraconazole and Rifampin on the PK of Vemurafenib at Steady State
Study ID: NCT02608034
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Center; Gastroenterology, Seoul, , Korea, Republic of
Asan Medical Center; Division of Oncology, Seoul, , Korea, Republic of
Severance Hospital - Yonsei Uni ; Obstetrics & Gynaecology Dept., Seoul, , Korea, Republic of
Republican Clinical Oncologic Dispensary of Republic Of Tatarstan, Kazan, , Russian Federation
FSBSI "N. N. Blokhin Russian Cancer Research Center", Moscow, , Russian Federation
St. Petersburg Oncology Hospital, St Petersburg, , Russian Federation
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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