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This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nilotinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMN107 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) in all patients with either sunitinib-resistant GIST or in patients with GIST who are intolerant of sunitinib | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| DCR in patients with sunitinib-resistant GIST, Progression free survival (PFS), overall survival (OS), Objective response rate (ORR) | 24 weeks | |
| Safety | 24 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Nagoya | Aichi-ken | 464-8681 | Japan | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21456006 | Result | 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. |
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| PK profile |
| 24 weeks |
| 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 |
| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C498826 | nilotinib |
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