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

Phase 1

Completed

• Conditions: cMET Dysegulation Advanced Solid Tumors
• Interventions: Drug: INC280

• Registration Number: NCT02925104
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-04
• Study First Submitted QC: 2016-10-04
• Study First Posted: 2016-10-05
• Study Start: 2016-12-14
• Primary Completion: 2018-05-16
• Study Completion: 2018-05-16
• Status Verified: 2020-02
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
INC280	INC280	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Indiana University Simon Cancer Center SC; 🇺🇸 Indianapolis, Indiana, United States

Novartis Investigative Site; 🇬🇧 Manchester, United Kingdom