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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors

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Trial Information

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


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.

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.

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence rate of dose-limiting toxicities and adverse events

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Singapore: Health Sciences Authority

Study ID:

CINC280X2102

NCT ID:

NCT01324479

Start Date:

March 2012

Completion Date:

May 2015

Related Keywords:

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

Name

Location

University of Chicago Medical Center SCChicago, Illinois  60546
Sarah Cannon Research Institute Dept of OncNashville, Tennessee  37203
MD Anderson Cancer Center/University of Texas Dept of OncHouston, Texas  77030-4009