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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02608034
• Date of registration: 03/11/2015
• Prospective Registration: Yes
• Primary sponsor: Genentech, Inc.
• Public title: A Study to Investigate the Effect of Itraconazole and Rifampin on Pharmacokinetics (PK) of Vemurafenib at Steady State
• Scientific 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
• Date of first enrolment: May 26, 2016
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02608034
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Israel, Korea, Republic of, Russian Federation, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Metastatic Melanoma, BRAF V600 Mutation Positive

Intervention(s)

Drug: Itraconazole

Drug: Vemurafenib

Drug: Rifampin

Primary Outcome(s)

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]

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]

Secondary Outcome(s)

Incidence of adverse events [Time Frame: 28 days after last dose of study treatment (last dose = Day 40)]

Secondary ID(s)

GO29475

Source(s) of Monetary Support

Please refer to primary and secondary sponsors