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

Phase 1

Completed

• Conditions: Advanced Solid Tumor
• Interventions: Drug: INC280

• Registration Number: NCT01546428
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-27
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-07
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-06
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
INC280	INC280	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Fukuoka, Japan