Status:
COMPLETED
Patients Completing Core Protocol (CAMN107A2103), Exhibiting Stable Disease (SD), Partial Response (PR) or Complete Response (CR) to Nilotinib in Combination With Imatinib
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
To provide study drug to patients that benefit from treatment judged by the investigator - to obtain additional long-term safety and efficacy data of this combination regimen in GIST
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Documented Complete Response, Partial Response, or Stable Disease at the time of entry to extension study and/or possible benefit from continuing treatment in the view of the investigator.
- Normal organ and marrow function as defined in core protocol (CAMN107A2103).
- Extension protocol written informed consent.
- Exclusion criteria:
- Inability to swallow the medication.
- Any unresolved adverse events related to participation in the core protocol (CAMN107A2103).
- A history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits.
- Other protocol defined inclusion/exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00441155
Start Date
November 1 2006
End Date
January 1 2011
Last Update
May 13 2013
Active Locations (4)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
3
Novartis Investigative Site
Lyon, France, 69373
4
Novartis Investigative Site
Milan, MI, Italy, 20133