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

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

  • ORG STUDY ID: CINC280X2102
  • SECONDARY ID: 2010-024101-12
  • NCT ID: NCT01324479

Conditions

  • Solid Tumors

Interventions

DrugSynonymsArms
INC280INC280

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.

Trial Arms

NameTypeDescriptionInterventions
INC280Experimental
  • 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence rate of dose-limiting toxicities and adverse events
Time Frame:2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective response by local investigator assessment
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • Non-small cell lung cancer,
  • hepatocellular,
  • gastric,
  • renal cell,
  • c-MET,
  • refractory,
  • glioblastoma,
  • breast,
  • nasopharyngeal,
  • confirmed evidence of c-MET dysregulation

Last Updated

December 19, 2020