A DDI Study to Assess the Effect of INC280 on the PK of Midazolam and Caffeine in Patients With cMET-dysregulated Advanced Solid Tumors

Inclusion Criteria:

Patients must have:

* advanced solid tumors and have confirmed cMET dysregulation
* at least one measurable lesion as defined by RECIST 1.1.
* recovered from all toxicities related to prior anti-cancer therapies
* adequate organ function
* ECOG performance status (PS) of 0 or 1

Exclusion Criteria:

Patients must not have:

* known hypersensitivity to any of the excipients of INC280 or to benzodiazepines or known intolerance and hypersensitivity to caffeine
* symptomatic central nervous system (CNS) metastases who are neurologically unstable
* presence or history of carcinomatous meningitis
* history of another primary malignancy that is currently clinically significant or currently requires active intervention
* Clinically significant, uncontrolled heart diseases, including QTcF ≥ 450 ms (male patients), ≥ 460 ms (female patients) on the screening ECG
* Thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting INC280
* Major surgery within 4 weeks prior to starting INC280
* Patients receiving unstable or increasing doses of corticosteroids.
* Impairment of GI function or GI disease that may significantly alter the absorption of INC280
* Patients who have received or consumed, or are expected to receive or consume midazolam or caffeine-containing products (e.g., tea, coffee, cola), within 2 days prior to Day 1 and during the whole duration of the DDI phase (i.e., from Day -2 to Day 12)

Other protocol-defined inclusion/exclusion criteria may apply