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
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.
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
Other protocol-defined inclusion/exclusion criteria may apply.