Patients Completing Core Protocol (CAMN107A2103), Exhibiting Stable Disease (SD), Partial Response (PR) or Complete Response (CR) to Nilotinib in Combination With Imatinib

Completed · Phase 1

Conditions studied: Gastrointestinal Stromal Tumors

In brief

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

Key facts

Study ID

NCT00441155

Run by

Novartis Pharmaceuticals

People needed

14

Starts

2006-11-01

Expected to finish

2011-01-01

Last updated by the study team

2013-05-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Lyon, France
• Novartis Investigative Site — Milan, MI, Italy

Full record on ClinicalTrials.gov

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