Study of INC280 in Patients With c-MET Dependent Advanced Solid Tumors (NCT01324479) | Clinical Trial Compass
CompletedPhase 1
Study of INC280 in Patients With c-MET Dependent Advanced Solid Tumors
United States131 participantsStarted 2012-02-29
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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-a…
What they're measuring
1
Incidence rate of dose-limiting toxicities and adverse events