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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

Trial Eligibility

Document

A Study to Investigate the Effect of <span class="go-doc-concept go-doc-intervention">Itraconazole</span> and Rifampin on Pharmacokinetics (PK) of Vemurafenib at Steady State

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

    NCT ID: NCT02608034

    ORG ID: GO29475

    Trial Conditions

    Metastatic Melanoma, BRAF V600 Mutation Positive

    Trial Interventions

    Drug Synonyms Arms
    Itraconazole Part 1: Vemurafenib+Itraconazole
    Rifampin Part 1: Vemurafenib+Itraconazole
    Vemurafenib Part 1: Vemurafenib+Itraconazole

    Trial 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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Part 1: Vemurafenib+Itraconazole Experimental 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). 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.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Area under the concentration-time curve From Time 0 to 12 Hours Postdose (AUC0-12)

    Maximum observed concentration (Cmax)

    Time to maximum concentration (Tmax)

    Secondary Outcome Measures

    Incidence of adverse events

    Trial Keywords