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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-000561-18 | EudraCT Number |
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This study is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resistant GIST, and to characterize the safety, tolerability and pharmacokinetic (PK) profile of this combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMN107 + STI571 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMN107, STI571 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the MTD which will be the Phase II dose of AMN107 when given in combination with Imatinib. The MTD is defined to be the highest dose of AMN107 in combination with Imatinib given for at least 21 days in the first treatment cycle | MTD is defined to be the highest dose of AMN in combination with imatinib given for at least 21 days in the first treatment cycle | From day 1 cycle 1 until at least six subjects have been treated at the recommended dose level and observed for at least 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize safety and tolerability of AMN107 in combination with Imatinib in GIST | From day 1 cycle to the study completion visit | |
| patients showing progression of disease on Imatinib. The patient will be followed-up for at least 4 cycles (28 days for one cycle) |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Additional inclusion and/ or 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 | Boston | Massachusetts | 02115 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CAMN107A2103 can be found on the Novartis Clinical Trial Results Website | View source |
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| 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 |
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| ID | Term |
|---|---|
| C498826 | nilotinib |
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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cycle = 28 days
| up to 4 cycles after disease profression on imatinib |
| Philadelphia |
| Pennsylvania |
| 19111-2497 |
| United States |
| Novartis Investigative Site | Lyon | 69373 | France |
| Novartis Investigative Site | Berlin | 13125 | Germany |
| Novartis Investigative Site | Milan | MI | 20133 | Italy |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |