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

• Status: Completed
• Trial end date: 2017-09-12
• Target enrollment: 0
• Participant gender: All

Summary

Drg-drug Interaction (DDI) study to assess the effect of INC280 on the pharmacokinetics of midazolam and caffeine in patients with cMET-dysregulated advanced solid tumors

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Caffeine; Midazolam

Criteria

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