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A Drug-drug Interaction (DDI) Study to Assess the Effect of INC280 on the Pharmacokinetics of Digoxin and Rosuvastatin in Patients With cMET-dysregulated Advanced Solid Tumors

NCT02626234

Description:

the study aim to assess the effect of INC280 on the pharmacokinetics of digoxin and rosuvastatin in patients with cMET-dysregulated advanced solid tumors

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

A Drug-drug Interaction (DDI) Study to Assess the Effect of INC280 on the Pharmacokinetics of Digoxin and Rosuvastatin in Patients With <span class="go-doc-concept go-doc-biomarker">cMET</span>-dysregulated Advanced Solid Tumors

Title

  • Brief Title: A Drug-drug Interaction (DDI) Study to Assess the Effect of INC280 on the Pharmacokinetics of Digoxin and Rosuvastatin 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 Digoxin and Rosuvastatin in Patients With cMET-dysregulated Advanced Solid Tumors
  • Clinical Trial IDs

    NCT ID: NCT02626234

    ORG ID: CINC280A2105

    Trial Conditions

    cMET-dysregulated Advanced Solid Tumors

    Trial Interventions

    Drug Synonyms Arms
    INC280 INC280
    digoxin INC280
    rosuvastatin INC280

    Trial Purpose

    the study aim to assess the effect of INC280 on the pharmacokinetics of digoxin and
    rosuvastatin in patients with cMET-dysregulated advanced solid tumors

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    INC280 Experimental INC280, digoxin, rosuvastatin

    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

    - prior treatment with cMET or HGF-targeting inhibitor

    - known hypersensitivity to digoxin or rosuvastatin or its excipients

    - 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 msec (male
    patients), 460 msec (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 are expected to receive digoxin or rosuvastatin within
    21 days prior to the beginning of the DDI phase (Day 1) and for the duration of the
    DDI phase.

    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 digoxin and rosuvastatin

    AUCinf of digoxin and rosuvastatin

    Lambda_z of digoxin and rosuvastatin

    Cmax of digoxin and rosuvastatin

    Tmax of digoxin and rosuvastatin

    T1/2 of digoxin and rosuvastatin

    CL/F of digoxin and rosuvastatin

    Vz/F of digoxin and rosuvastatin

    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

    Concentration of INC280 during DDI phase

    Trial Keywords

    cMET, INC280, rosuvastatin, digoxin