NCT02608034 - A Study to Investigate the Effect of Itraconazole and Rifampin on Pharmacokinetics (PK) of Vemurafenib at Steady State | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 26, 2016

Primary Completion Date

September 10, 2018

Study Completion Date

September 10, 2018

Conditions

Metastatic Melanoma, BRAF V600 Mutation Positive

Interventions

DRUG

Itraconazole

Itraconazole will be administered as a 200 mg oral solution QD during Part 1 only for 20 consecutive days.

DRUG

Rifampin

Rifampin will be administered as a 600 mg oral solution QD during Part 2 only for 20 consecutive days.

DRUG

Vemurafenib

Vemurafenib will be administered in both Part 1 and Part 2 at a dose of 960 mg BID for at least 40 conseutive days.

Trial Locations (11)

Tel Aviv Sourasky Medical Center; Pharmacy, Tel Aviv

Mary Crowley Medical Research Center, Dallas

"FSBSI N. N. Blokhin Russian Cancer Research Center", Moscow

St. Petersburg Oncology Hospital, Saint Petersburg

Republican Clinical Oncologic Dispensary of Republic Of Tatarstan, Kazan'

Rambam Health Care Campus; Oncology, Haifa

Hadassah Ein Karem Hospital; Oncology Dept, Jerusalem

Seoul National University Hospital, Seoul

Samsung Medical Center; Gastroenterology, Seoul

Asan Medical Center; Division of Oncology, Seoul

Severance Hospital - Yonsei Uni ; Obstetrics & Gynaecology Dept., Seoul