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Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination (MACS2226)

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01613053
First Posted: June 6, 2012
Last Update Posted: April 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
Continuation of drug supply in Chinese patients after CAMN107DBR01study termination.

Condition Intervention
Gastrointestinal Stromal Tumor Drug: Glivec

Study Type: Expanded Access     What is Expanded Access?
Official Title: Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Intervention Details:
    Drug: Glivec
    800 mg per day
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01613053


Locations
China, Sichuan
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
China
Novartis Investigative Site
Guang zhou, China, 510080
Novartis Investigative Site
Shanghai, China, 200025
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Principal Investigator: Jie Zhong, M.D. Ruijin Hospital of Shanghai Jiaotong University
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01613053     History of Changes
Other Study ID Numbers: CAMN107DCN03
First Submitted: June 4, 2012
First Posted: June 6, 2012
Last Update Posted: April 24, 2015
Last Verified: April 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Gastrointestinal Stromal Tumor, GIST

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases