Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination (MACS2226)
This study is currently recruiting participants.
Verified June 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01613053
First received: June 4, 2012
Last updated: June 16, 2013
Last verified: June 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 4, 2012 | ||||||||
| Last Updated Date | June 16, 2013 | ||||||||
| Start Date ICMJE | July 2012 | ||||||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01613053 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination | ||||||||
| Official Title ICMJE | Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination | ||||||||
| Brief Summary | Continuation of drug supply in Chinese patients after CAMN107DBR01study termination. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label |
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| Condition ICMJE | Gastrointestinal Stromal Tumor | ||||||||
| Intervention ICMJE | Drug: Glivec
800 mg per day |
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| Study Arm (s) | 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.
Intervention: Drug: Glivec |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 5 | ||||||||
| Estimated Completion Date | July 2014 | ||||||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01613053 | ||||||||
| Other Study ID Numbers ICMJE | CAMN107DCN03 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Novartis ( Novartis Pharmaceuticals ) | ||||||||
| Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Novartis | ||||||||
| Verification Date | June 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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