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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:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01613053
First received: June 4, 2012
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

Continuation of drug supply in Chinese patients after CAMN107DBR01study termination.


Condition Intervention Phase
Gastrointestinal Stromal Tumor
Drug: Glivec
Phase 4

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:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • N/A.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01613053     History of Changes
Other Study ID Numbers: CAMN107DCN03
Study First Received: June 4, 2012
Last Updated: November 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Gastrointestinal Stromal Tumor, GIST

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

ClinicalTrials.gov processed this record on November 27, 2014