A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors

INC280 will be administered to Japanese patients with advanced soid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will assess the safety and tolerability and determine the maximum tolerated dose (MTD) on INC280

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: INC280

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 811-1395
    • Novartis Investigative Site
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Advanced solid tumors that are refractory to currently available therapies or for which no effective treatment is available.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
• Good organ (hepatic, kidney, BM) function at screening/baseline visit.

Exclusion criteria:

• Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of INC280.
• Undergone a bone marrow or solid organ transplant.
• Women who are pregnant or breast feeding.

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INC280	Drug: INC280

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Dose Limiting Toxicities (DLT) in the dose escalation part	Incidence and frequency of DLT during the first cycle of INC280 treatment in the dose escalation part according to the CTCAE.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events and serious adverse events, changes in laboratory values	Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment.	4 months
Plasma concentration of INC280 and derived PK parameters of INC280 such as Tmax, AUC and T1/2	Plasma concentration of INC280 and derived PK parameters of INC280 will be measured with serial plasma samples during treatment for first months.	1 month
Preliminary tumor responses according to RECIST 1.1 or MacDonald criteria for GBM	Tumor responses will be measured according to RECIST 1.1 or MacDonald criteria for GBM	4 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CINC280X1101 can be found on the Novartis Clinical Trial Results Website

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: February 27, 2012
• First Submitted That Met QC Criteria: March 1, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Advanced solid tumor; c-MET
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CINC280X1101