A Drug-drug Interaction (DDI) Study to Assess the Effect of INC280 on the Pharmacokinetics of Digoxin and Rosuvastatin in Patients With cMET-dysregulated Advanced Solid Tumors

• Status: Completed
• Trial end date: 2017-04-28
• Target enrollment: 0
• Participant gender: All

Summary

the study aim to assess the effect of INC280 on the pharmacokinetics of digoxin and rosuvastatin in patients with cMET-dysregulated advanced solid tumors

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Digoxin; Rosuvastatin Calcium

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

• prior treatment with cMET or HGF-targeting inhibitor

• known hypersensitivity to digoxin or rosuvastatin or its excipients

• 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 msec (male patients), ≥ 460 msec (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 are expected to receive digoxin or rosuvastatin within 21 days prior to the beginning of the DDI phase (Day 1) and for the duration of the DDI phase.

Other protocol-defined inclusion/exclusion criteria may apply