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An open-label, non-comparative study conducted to investigate the activity and safety of imatinib mesylate in refractory desmoplastic small round cell tumors expressing PDGF-R. Patients will be treated up to 12 months, or to disease progression. Tumor will be evaluated according to Recist criteria
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gleevec/Glivec | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib mesilate | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall tumor response rates | An imaging technique (CT scan or MRI) determined tumor response according to RECIST criteria. | Assessed every 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Explore how Imatinib cooperated with other treatment modatilities | Recorded survival after treatment and other associated treatment modalities. | Survival data was collected until death |
| Safety and tolerability |
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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 Pharmeceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Ivrea | Italy | ||||
| Novartis Investigative Site |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| Safety data collected until patients were no longer in study |
| Conversion rate to surgical resectability | Assessed actual resectability rate after therapy compared to resectability before therapy. | After best tumor response. |
| Mutational analysis of molecular targets of imatinib (at any time during the study) | At any time during the study |
| Milan |
| Italy |
| Novartis Investigative Site | Naples | Italy |
| Novartis Investigative Site | Padova | Italy |
| Novartis Investigative Site | Ravenna | Italy |
| Novartis Investigative Site | Rozzano | Italy |
| Novartis Investigative Site | Torino | Italy |
| Novartis Investigative Stie | Vatania | Italy |
| 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 |