Back to resultsContinuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination (MACS2226)
Primary Purpose
Gastrointestinal Stromal Tumor
Status
No longer available
Phase
Locations
China
Study Type
Expanded Access
Intervention
Glivec
Sponsored by
About this trial
This is an expanded access trial for Gastrointestinal Stromal Tumor focused on measuring Gastrointestinal Stromal Tumor, GIST
Eligibility 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.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01613053
Brief Title
Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination
Acronym
MACS2226
Official Title
Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination
Study Type
Expanded Access
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Continuation of drug supply in Chinese patients after CAMN107DBR01study termination.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumor
Keywords
Gastrointestinal Stromal Tumor, GIST
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Glivec
Intervention Description
800 mg per day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Zhong, M.D.
Organizational Affiliation
Ruijin Hospital of Shanghai Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigative Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Novartis Investigative Site
City
Guang zhou
ZIP/Postal Code
510080
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200025
Country
China
12. IPD Sharing Statement
Learn more about this trial
Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination
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