Clinical Trials /

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

NCT02608034

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT02608034

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: GO29475
  • NCT ID: NCT02608034

Conditions

  • Metastatic Melanoma, BRAF V600 Mutation Positive

Interventions

DrugSynonymsArms
ItraconazolePart 1: Vemurafenib+Itraconazole
RifampinPart 1: Vemurafenib+Itraconazole
VemurafenibPart 1: Vemurafenib+Itraconazole

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Part 1: Vemurafenib+ItraconazoleExperimentalPart 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).
  • Itraconazole
  • Rifampin
  • Vemurafenib

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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence of adverse events
Time Frame:28 days after last dose of study treatment (last dose = Day 40)
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Genentech, Inc.

Last Updated

February 12, 2020