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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms of nilotinib (AMN107) are effective against KIT/PDGFRA mutations in GIST patients post-Imatinib and Sunitinib failure?
How does nilotinib's efficacy in GIST compare to other tyrosine kinase inhibitors like Regorafenib or Pazopanib in third-line therapy?
Which biomarkers correlate with nilotinib response in GIST patients who are resistant to Imatinib and Sunitinib?
What are the most common adverse events associated with nilotinib treatment in GIST patients after failure of first and second-line therapies?
Are there any combination therapies involving nilotinib (AMN107) being explored for advanced gastrointestinal stromal tumors resistant to Imatinib and Sunitinib?
Trial Locations
- Locations (1)
Novartis Investigative Site
🇯🇵Chuo-ku, Tokyo, Japan
Novartis Investigative Site🇯🇵Chuo-ku, Tokyo, Japan