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

Novartis

Status and phase: Completed; Phase 1

Conditions: cMET Dysegulation Advanced Solid Tumors

Treatments: Drug: INC280

Study type: Interventional

Funder types: Industry

Identifiers

NCT02925104

CINC280A2108

2016-001829-14 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

INC280

Experimental group

Treatment:

Drug: INC280