Patients Completing Core Protocol (CAMN107A2103), Exhibiting Stable Disease (SD), Partial Response (PR) or Complete Response (CR) to Nilotinib in Combination With Imatinib
- Registration Number
- NCT00441155
- Lead Sponsor
- Novartis Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Combination Therapy: AMN107 + Imatinib Nilotinib, Imatinib six possible doses of Nilotinib (100 mg once daily (qd), 200 mg qd, 400 mg qd, 200 mg bid, 300 mg bid, and 400 mg bid). four possible doses of Imatinib (0 mg, 400 mg qd, 600 mg qd, and 400 mg bid).the initial dose of nilotinib (dose level 1) was 200 mg qd and could have been escalated up to 400 mg bid Monotherapy: AMN107 Nilotinib, Imatinib initial dose of imatinib (dose level 1) was 400 mg bid was administered orally on a continuous daily schedule and was not escalated during the study
- Primary Outcome Measures
Name Time Method Safety and tolerability of nilotinib either as single agent or in combination with Imatinib 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 Assessed by AE evaluation, including safety laboratory and cardiac safety (ECG, cardiac enzymes, ECHO) measures.
- Secondary Outcome Measures
Name Time Method To assess any clinical responses in Imatinib-resistant GIST patients. Assessment of tumor response will be made based on modified RECIST criteria - to be assessed at the end of every cycle of treatment every 3 months, at completion of every third treatment cycle prior to first dose of next cycle, at study completion visit Assessment of tumor response will be made based on modified RECIST criteria.
Trial Locations
- Locations (3)
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Novartis Investigative Site
🇮🇹Milano, MI, Italy