A Dose Escalation Study to Assess PK, Safety and Tolerability of INC280 When Taken With Food in cMET Dysregulated Advanced Solid Tumors.

• Status: Completed
• Trial end date: 2018-05-16
• Target enrollment: 0
• Participant gender: All

Summary

Dose escalation study to assess PK, safety and tolerability of INC280 when taken with food in patients with cMET dysregulated advanced solid tumors.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• cMET dysregulated advanced solid tumor

• At least one measurable lesion as defined by RECIST 1.1

• Recovered from all toxicities related to prior anti-cancer therapies to grade ≤ 1

• Adequate organ function

• ECOG performance status (PS) ≤ 1

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 (CNS) metastases who are neurologically unstable

• Presence or history of a malignant disease other than the study related cancer

• Clinically significant, uncontrolled heart diseases

• Thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting INC280 or patients who have not recovered from radiotherapy-related toxicities

• Major surgery within 4 weeks prior to starting INC280

• Impairment of GI function

• Patients receiving unstable or increasing doses of corticosteroids

• Patients receiving treatment with any enzyme-inducing anticonvulsant

• Pregnant or nursing (lactating) women Other protocol-related inclusion/exclusion criteria may apply