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

This study is not yet open for participant recruitment.
Verified February 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01613053
First received: June 4, 2012
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

Continuation of drug supply in Chinese patients after CAMN107DBR01study termination.


Condition Intervention Phase
Gastrointestinal Stromal Tumor
 Drug: Glivec
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glivec
All five patients will receive Glivec treatment (800 mg per day )until tumor progression [by RECIST guidelines, version 1.0], unacceptable toxicity, death or withdrawal of consent.
 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613053

Contacts
Contact: Novartis Pharmaceuticals, M.D. +41613241111
Contact: Novartis Pharmaceuticals

Locations
China, Sichuan
Novartis Investigative Site Recruiting
Chengdu, Sichuan, China, 610041
China
Novartis Investigative Site Recruiting
Guang zhou, China, 510080
Novartis Investigative Site Recruiting
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: February 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Gastrointestinal Stromal Tumor, GIST

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013