Trial Information
An Extension to a Phase I Multicenter, Dose Escalation Study of Nilotinib in Combination With Imatinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-Resistant Gastrointestinal Stromal Tumors (GIST)
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability of nilotinib either as single agent or in combination with Imatinib
Outcome Description:
Assessed by AE evaluation, including safety laboratory and cardiac safety (ECG, cardiac enzymes, ECHO) measures.
Outcome Time Frame:
AE monitored continuously from day 1 cycle 1 to the study completion visit; safety laboratory and cardiac safety monitored every 3 treatment cycles (every 3 months) from day 1 cycle 1 to the study completion visit
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CAMN107A2103E1
NCT ID:
NCT00441155
Start Date:
November 2006
Completion Date:
January 2011
Related Keywords:
- Gastrointestinal Stromal Tumors
- Oncology
- Cancer
- Imatinib-Resistant Gastrointestinal Stromal Tumors
- GIST
- Nilotinib
- Imatinib-Resistant Gastrointestinal Stromal Tumors (GIST)
- Gastrointestinal Stromal Tumors
Name | Location |
|---|
| Fox Chase Cancer Center |
Philadelphia, Pennsylvania 19111 |
| Dana Farber Cancer Institute |
Boston, Massachusetts 02115 |
