Status:
COMPLETED
Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00718562
Start Date
September 1 2008
End Date
July 1 2013
Last Update
February 23 2017
Active Locations (8)
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1
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 464-8681
2
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277-8577
3
Novartis Investigative Site
Fukuoka, Fukuoka, Japan, 812-8582
4
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 060-8648