Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib
A Multi-center Phase II Study to Evaluate the Efficacy and Safety of AMN107 (Nilotinib) in Patients With Gastrointestinal Stromal Tumors Who Have Progressed on or Are Intolerant to Both Imatinib and Sunitinib
1 other identifier
interventional
35
1 country
8
Brief Summary
This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2008
Longer than P75 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2008
CompletedFirst Posted
Study publicly available on registry
July 18, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedFebruary 23, 2017
February 1, 2017
4.8 years
July 16, 2008
February 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
DCR in patients with sunitinib-resistant GIST, Progression free survival (PFS), overall survival (OS), Objective response rate (ORR)
24 weeks
Safety
24 weeks
PK profile
24 weeks
Study Arms (1)
Nilotinib
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Novartis Investigative Site
Nagoya, Aichi-ken, 464-8681, Japan
Novartis Investigative Site
Kashiwa, Chiba, 277-8577, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, 812-8582, Japan
Novartis Investigative Site
Sapporo, Hokkaido, 060-8648, Japan
Novartis Investigative Site
Niigata, Niigata, 951-8520, Japan
Novartis Investigative Site
Suita, Osaka, 565-0871, Japan
Novartis Investigative Site
Sunto-gun, Shizuoka, 411-8777, Japan
Novartis Investigative Site
Chuo-ku, Tokyo, 104-0045, Japan
Related Publications (1)
Sawaki A, Nishida T, Doi T, Yamada Y, Komatsu Y, Kanda T, Kakeji Y, Onozawa Y, Yamasaki M, Ohtsu A. Phase 2 study of nilotinib as third-line therapy for patients with gastrointestinal stromal tumor. Cancer. 2011 Oct 15;117(20):4633-41. doi: 10.1002/cncr.26120. Epub 2011 Mar 31.
PMID: 21456006RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2008
First Posted
July 18, 2008
Study Start
September 1, 2008
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
February 23, 2017
Record last verified: 2017-02