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A Phase I Study of Oral BGJ398 in Asian Patients

NCT ID: NCT01697605

Last Updated: 2020-12-08

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

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-19

Study Completion Date

2019-02-07

Brief Summary

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This study will evaluate safety and tolerability to determine the Maximum tolerated dose (MTD) and/or Recommended dose (RD).

Detailed Description

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This is a multi-center, open label, dose finding, phase I study of oral single agent BGJ398, administered on a continuous once and/or twice daily schedule.

Conditions

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Tumor With Alterations of the FGF-R

Keywords

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Phase I, open-label, dose escalation, BGJ398, Japanese, Asian, FGF-R

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BGJ398

Eligible participants received oral BGJ398 once daily or twice daily. Patients may continue treatment with BGJ398 until the patient experiences unacceptable toxicity or progressive disease.

Group Type EXPERIMENTAL

BGJ398

Intervention Type DRUG

Interventions

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BGJ398

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with advanced solid tumors with FGF-R alteration
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate organ function

Exclusion Criteria

* Patients with untreated and/or symptomatic metastatic Central Nerve System (CNS) disease
* Pregnant or nursing (lactating) women
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

Guangzhou, Guangdong, China

Site Status

Novartis Investigative Site

Chengdu, Sichuan, China

Site Status

Novartis Investigative Site

Guangzhou, , China

Site Status

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Site Status

National Cancer Center Hospital East (NCEE)

Kashiwa, Chiba, Japan

Site Status

Novartis Investigative Site

Kobe, Hyōgo, Japan

Site Status

Novartis Investigative Site

Sayama, Osaka, Japan

Site Status

Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

Site Status

Countries

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China Japan

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17561

Results for CBGJ398X1101 can be found on the Novartis Clinical Trials Results website

Other Identifiers

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CBGJ398X1101

Identifier Type: -

Identifier Source: org_study_id