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MACS2226: Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
No longer available
CT.gov ID
NCT01613053
Collaborator
(none)
3
Locations

Study Details

Study Description

Brief Summary

Continuation of drug supply in Chinese patients after CAMN107DBR01study termination.

Condition or Disease Intervention/Treatment Phase

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 Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Chengdu Sichuan China 610041
    2 Novartis Investigative Site Guang zhou China 510080
    3 Novartis Investigative Site Shanghai China 200025

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Principal Investigator: Jie Zhong, M.D., Ruijin Hospital of Shanghai Jiaotong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01613053
    Other Study ID Numbers:
    • CAMN107DCN03
    First Posted:
    Jun 6, 2012
    Last Update Posted:
    Apr 24, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Novartis Pharmaceuticals
    Gastrointestinal Stromal Tumor, GIST
    Additional relevant MeSH terms:
    Gastrointestinal Stromal Tumors
    Imatinib Mesylate

    Study Results

    No Results Posted as of Apr 24, 2015