Clinical Trials /

Study of INC280 in Patients With c-MET Dependent Advanced Solid Tumors

NCT01324479

Description:

This study will assess the safety and efficacy of INC280 in patients with solid tumors that are refractory to current treatment or for which there is not a current standard of care and whose tumors have dysregulation of the c-MET pathway.

Related Conditions:
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Study of INC280 in Patients With c-<span class="go-doc-concept go-doc-biomarker">MET</span> Dependent Advanced Solid Tumors

Title

  • Brief Title: Study of INC280 in Patients With c-MET Dependent Advanced Solid Tumors
  • Official Title: A Phase I Open-label Dose Escalation Study With Expansion to Assess the Safety and Tolerability of INC280 in Patients With c-MET Dependent Advanced Solid Tumors
  • Clinical Trial IDs

    NCT ID: NCT01324479

    ORG ID: CINC280X2102

    NCI ID: 2010-024101-12

    Trial Conditions

    Solid Tumors

    Trial Interventions

    Drug Synonyms Arms
    INC280 INC280

    Trial Purpose

    This study will assess the safety and efficacy of INC280 in patients with solid tumors that
    are refractory to current treatment or for which there is not a current standard of care and
    whose tumors have dysregulation of the c-MET pathway.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    INC280 Experimental INC280

    Eligibility Criteria

    Inclusion Criteria:

    - Must have evidence of c-MET dysregulation from either local data or the results of
    molecular pre-screening evaluations.

    - Confirmed diagnosis of a solid tumor.

    - Measureable lesion.

    - Refractory to currently available treatment or no therapies available.

    - 18 years or older.

    - ECOG performance status of 0, 1, or 2.

    - Obtained written informed consent.

    Additional inclusion criteria for NSCLC patients EGFRwt with high c-MET expression:

    - Written documentation of EGFRwt NSCLC.

    - Written documentation of c-MET positivity.

    - Patients should not have received more than three prior lines of antineoplastic
    therapy for NSCLC.

    - Presence of at least one measurable lesion as determined by modified RECIST version
    1.1

    Exclusion Criteria:

    HCC with liver dysfunction greater than Child-Pugh A. Previous treatment with a c-MET
    inhibitor or HGF-targeting therapy. Symptomatic CNS metastases that are neurologically
    unstable or requiring increasing doses of steroids to control their CNS disease.

    Any CNS deficits. For patients with GBM, CNS symptoms grade 2 or greater. Subjects with
    significant or uncontrolled cardiovascular disease (eg, uncontrolled hypertension,
    peripheral vascular disease, congestive heart failure, cardiac arrhythmia, or acute
    coronary syndrome) within 6 months of starting study treatment or heart attack within 12
    months of starting study treatment.

    Receiving anti-epileptic drugs that are known to be strong inducers of CYP3A4. Prior or
    current anti-angiogenic therapy for patients with GBM. Radiation therapy within 4 weeks
    (< 12 for GBM) prior to the first dose of study drug or limited field radiotherapy within
    2 weeks (< 12 weeks GBM) prior to the start of study treatment. Any persistent side
    effect of prior radiotherapy must be resolved to Grade 1 prior to the first dose of
    study drug.

    Additional exclusion criteria for NSCLC patients EGFRwt with high c-MET expression:

    - Patients who have received more than three prior lines of antineoplastic therapies

    - Any unresolved toxicity (CTCAE grade > 1) from previous anti-cancer therapy or
    radiotherapy, except alopecia

    - Patients have received anti-cancer therapies within the following time frames prior
    to the first dose of study treatment:

    - Conventional cytotoxic chemotherapy: 4 weeks (6 weeks for nitrosoureas and
    mitomycin-C)

    - Biologic therapy (e.g., antibodies): 4 weeks

    - Non-cytotoxic small molecule therapeutics: 5 half-lives or 2 weeks (whichever
    is longer)

    - Other investigational agents: 4 weeks

    - Radiation therapy (palliative setting is allowed.): 4 weeks

    - Major surgery: 2 weeks

    Other protocol-defined inclusion/exclusion criteria may apply.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Incidence rate of dose-limiting toxicities and adverse events

    Secondary Outcome Measures

    Objective response

    Trial Keywords

    Non-small cell lung cancer,

    hepatocellular,

    gastric,

    renal cell,

    c-MET,

    refractory,

    glioblastoma,

    breast,

    nasopharyngeal,

    confirmed evidence of c-MET dysregulation