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A DDI Study to Assess the Effect of INC280 on the PK of Midazolam and Caffeine in Patients With cMET-dysregulated Advanced Solid Tumors

NCT02520752

Description:

Drg-drug Interaction (DDI) study to assess the effect of INC280 on the pharmacokinetics of midazolam and caffeine in patients with cMET-dysregulated advanced solid tumors

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

A DDI Study to Assess the Effect of INC280 on the PK of <span class="go-doc-concept go-doc-intervention">Midazolam</span> and <span class="go-doc-concept go-doc-intervention">Caffeine</span> in Patients With <span class="go-doc-concept go-doc-biomarker">cMET</span>-dysregulated Advanced Solid Tumors

Title

  • Brief Title: A DDI Study to Assess the Effect of INC280 on the PK of Midazolam and Caffeine in Patients With cMET-dysregulated Advanced Solid Tumors
  • Official Title: A Phase I, Multicenter, Open-label, Single-sequence Drug-drug Interaction Study to Assess the Effect of INC280 on the Pharmacokinetics of Midazolam and Caffeine in Patients With cMET-dysregulated Advanced Solid Tumors
  • Clinical Trial IDs

    NCT ID: NCT02520752

    ORG ID: CINC280A2103

    Trial Conditions

    cMET-dysregulated Advanced Solid Tumors

    Trial Interventions

    Drug Synonyms Arms
    INC280 INC280
    Midazolam INC280
    Caffeine INC280

    Trial Purpose

    Drg-drug Interaction (DDI) study to assess the effect of INC280 on the pharmacokinetics of
    midazolam and caffeine in patients with cMET-dysregulated advanced solid tumors

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    INC280 Experimental INC280, Midazolam, Caffeine

    Eligibility Criteria

    Inclusion Criteria:

    Patients must have:

    - advanced solid tumors and have confirmed cMET dysregulation

    - at least one measurable lesion as defined by RECIST 1.1.

    - recovered from all toxicities related to prior anti-cancer therapies

    - adequate organ function

    - ECOG performance status (PS) of 0 or 1

    Exclusion Criteria:

    Patients must not have:

    - known hypersensitivity to any of the excipients of INC280 or to benzodiazepines or
    known intolerance and hypersensitivity to caffeine

    - symptomatic central nervous system (CNS) metastases who are neurologically unstable

    - presence or history of carcinomatous meningitis

    - history of another primary malignancy that is currently clinically significant or
    currently requires active intervention

    - Clinically significant, uncontrolled heart diseases, including QTcF 450 ms (male
    patients), 460 ms (female patients) on the screening ECG

    - Thoracic radiotherapy to lung fields 4 weeks prior to starting INC280

    - Major surgery within 4 weeks prior to starting INC280

    - Patients receiving unstable or increasing doses of corticosteroids.

    - Impairment of GI function or GI disease that may significantly alter the absorption
    of INC280

    - Patients who have received or consumed, or are expected to receive or consume
    midazolam or caffeine-containing products (e.g., tea, coffee, cola), within 2 days
    prior to Day 1 and during the whole duration of the DDI phase (i.e., from Day -2 to
    Day 12)

    Other protocol-defined inclusion/exclusion criteria may apply

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    AUClast of midazolam and caffeine

    AUCinf of midazolam and caffeine

    Lambda_z of midazolam and caffeine

    Cmax of midazolam and caffeine

    Tmax of midazolam and caffeine

    T1/2 of midazolam and caffeine

    CL/F of midazolam and caffeine

    Vz/F of midazolam and caffeine

    Secondary Outcome Measures

    Adverse events based on the CTCAE v4.03 grade (severity) and other safety data (e.g.,ECG, vital signs, laboratory results)

    Overall response rate of patients treated with INC280

    Disease control rate of patients treated with INC280

    Trial Keywords

    cMET, INC280, caffeine, midazolam