C-MET dependent solid tumors
Conditions
Interventions
Sponsors
Novartis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * * 18 years of age. * Cytopathologically or histolopathologically confirmed diagnosis of an advanced solid tumor harboring cMET dysregulation which has progressed despite standard therapy, or for which no standard therapy exists. See protocol page 30 for more details re cMET dysregulation. * At least one measurable lesion. * Adequate organ function. See protocol page 30-31 for more details. * ECOG performance status (PS) of 0 or 1.
Exclusion criteria
Exclusion criteria: * Prior treatment with crizotinib, or any other cMET or HGF inhibitor. * Known hypersensitivity to any of the excipients of INC280. * Symptomatic central nervous system metastases. See protocol page 31 for more details. * Clinically significant, uncontrolled heart diseases, including QTcF * 450 ms (male patients), * 460 ms (female patients) on the screening ECG. See protocol page 31 for more details. * Treatment with strong and moderate inhibitors of CYP3A4 or strong inducers of CYP3A4. * Treatment with medications mentioned in items 13-15 on page 32. * Pregnant or nursing (lactating) women. * Females and males not using adequate contraception. See protocol page 32-33 for more details.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicity in the first 28 days of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters, adverse events. | — |
Countries
Austria, Denmark, Germany, Netherlands, Spain, Sweden, United Kingdom, United States of America
Outcome results
None listed