A Study to Investigate the Effect of Itraconazole and Rifampin on Pharmacokinetics (PK) of Vemurafenib at Steady State

NCT ID: NCT02608034

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-26
• Study Completion Date: 2018-09-10

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.

Conditions

Metastatic Melanoma, BRAF V600 Mutation Positive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: Vemurafenib+Itraconazole

Part 1: Participants will receive vemurafenib orally BID up to Day 20 (Period A) followed by vemurafenib orally BID along with itraconazole orally once in the morning from Days 21 to 40 (Period B).\\nPart 2: Participants will receive vemurafenib orally BID up to Day 20 (Period A) followed by vemurafenib orally BID along with rifampin orally once in the morning from Days 21 to 40 (Period B).

Group Type: EXPERIMENTAL

Itraconazole

Intervention Type: DRUG

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

Rifampin

Intervention Type: DRUG

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

Vemurafenib

Intervention Type: DRUG

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

Interventions

Itraconazole

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

Intervention Type: DRUG

Rifampin

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

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

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

Countries

United States; Israel; Russia; South Korea

Other Identifiers

GO29475

Identifier Type: -

Identifier Source: org_study_id