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

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ClinicalTrials.gov Identifier: NCT01613053
Expanded Access Status : No longer available
First Posted : June 6, 2012
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
Continuation of drug supply in Chinese patients after CAMN107DBR01study termination.

Condition or disease Intervention/treatment
Gastrointestinal Stromal Tumor Drug: Glivec

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.

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



Intervention Details:
  • Drug: Glivec
    800 mg per day

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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:


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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01613053     History of Changes
Other Study ID Numbers: CAMN107DCN03
First Posted: June 6, 2012    Key Record Dates
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