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This study is a phase I dose escalation, multi-center, open-label study of HSP990 administered orally once weekly in adult Japanese and Korea patients with advanced solid malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSP990 | Experimental | dose escalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSP990 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| establish maximum tolerated dose (MTD) | 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Safety by measuring occurrence of dose limiting toxicity (DLT) and other adverse events | 2.5 years | |
| Efficacy by collecting data on response (complete response [CR], partial response [PR]) and stable disease (SD) | 2.5 years |
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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 | 466-8560 | Japan | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CHSP990A1101 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| C570862 | 2-amino-7-(4-fluoro-2-(6-methoxypyridin-2-yl)phenyl)-4-methyl-7,8-dihydropyrido(4,3-d)pyrimidin-5(6H)-one |
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| Establishment of a pharmacokinetic profile by collecting information on parameters including but not limited to Cmax, Tmax, T1/2 and AUC in plasma samples | 2.5 years |
| Measurement of biomarkers for HSP90 pathway in blood and tissue | 2.5 years |
| Kashiwa |
| Chiba |
| 277-8577 |
| Japan |