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

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

Official Title
-----------------
A Multicenter, Open Label, Phase 1 Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INC280 Tablet Formulation With Food in Patients With cMET Dysregulated Advanced Solid Tumors.

Conditions
-----------------
cMET Dysegulation Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: INC280


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INC280<br> | Drug: INC280<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Dose limiting toxiticites (DLTs) |  | During the first 28 days on INC280 treatment; cycle = 21 days | 
| Frequency of DLTs |  | During the first 28 days on INC280 treatment | 
| Category of DLTs |  | During the first 28 days on INC280 treatment | 
| AUClast for INC280 |  | Treatment Cycle 1 Day 1 (C1D1), C1D7, C1D15, C2D1, C3D1 | 
| AUCtau for INC280 |  | C1D1, C1D7, C1D15, C2D1, C3D1 | 
| Cmax for INC280 |  | C1D1, C1D7, C1D15, C2D1, C3D1 | 
| Tmax |  | C1D1, C1D7, C1D15, C2D1, C3D1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events based on CTCAE grading and other safety variables (e.g. EGC readings, physical examination, vital signs and laboratory results). |  | Screening, until 30 days post-treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cMET, INC280, food,