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

NCT ID: NCT01546428

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-01-31

Brief Summary

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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

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Conditions

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Advanced Solid Tumor

Keywords

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c-MET Advanced solid tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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INC280

Group Type EXPERIMENTAL

INC280

Intervention Type DRUG

Interventions

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INC280

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Kashiwa, Chiba, Japan

Site Status

Novartis Investigative Site

Fukuoka, , Japan

Site Status

Countries

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Japan

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=15330

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

Other Identifiers

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CINC280X1101

Identifier Type: -

Identifier Source: org_study_id