Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination

NCT ID: NCT01613053

Last Updated: 2015-04-24

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Continuation of drug supply in Chinese patients after CAMN107DBR01study termination.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Five patients who are on treatment of imatinib and deriving clinical benefit after CAMN107DBR01 study termination and written informed consent obtained will enter the trial, all five patients will receive Glivec (8oomg per day) treatment until tumor progression \[by RECIST guidelines, version 1.0\], unacceptable toxicity, death or withdrawal of consent.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Stromal Tumor

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Glivec

800 mg per day

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Five patients who are on treatment of imatinib and deriving clinical benefit after CAMN107DBR01 study termination and written informed consent obtained.

Exclusion Criteria

* N/A.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jie Zhong, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital of Shanghai Jiaotong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Chengdu, Sichuan, China

Site Status

Novartis Investigative Site

Guangzhou, , China

Site Status

Novartis Investigative Site

Shanghai, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CAMN107DCN03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Glivec Phase II Pediatric Study
NCT00180830 TERMINATED PHASE2