Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib
- Registration Number
- NCT00718562
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
- Documented disease progression during imatinib and sunitinib therapy OR intolerance to imatinib and/or sunitinib
- At least one measurable site of disease on CT/MRI scan
- PS≤2
- Normal organ, electrolyte, and bone marrow function
Exclusion Criteria
- Previous treatment with nilotinib or any other drug in this class or other targeted therapy
- Treatment with any cytotoxic and/or investigational drug ≤ 4 weeks prior to study entry
- Impaired cardiac function
- Use of coumarin derivatives (i.e. warfarin)
- Women who are pregnant or lactating
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nilotinib AMN107 -
- Primary Outcome Measures
Name Time Method Disease Control Rate (DCR) in all patients with either sunitinib-resistant GIST or in patients with GIST who are intolerant of sunitinib 24 weeks
- Secondary Outcome Measures
Name Time Method Safety 24 weeks PK profile 24 weeks DCR in patients with sunitinib-resistant GIST, Progression free survival (PFS), overall survival (OS), Objective response rate (ORR) 24 weeks
Trial Locations
- Locations (1)
Novartis Investigative Site
🇯🇵Chuo-ku, Tokyo, Japan