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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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This study will evaluate PTK787, a new oral drug that stops blood vessel development, in combination with Paclitaxel in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Paclitaxel plus PTK787 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel plus PTK787 | Drug | Paclitaxel will be given on days 1 and 15 over 28 days in cycle 1 with PTK787 on days 3 to 28. PTK787 WILL BE TAKEN AT NIGHT. In cycle 2 and beyond, paclitaxel will be given on days 1, 8 and 15 every 28 days . PTK787 will be taken orally NIGHTLY. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of escalating doses of paclitaxel in combination with PTK787 | Baseline through End of Study |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics of paclitaxel alone and in combination with PTK787 from patients with cancer accrued to this study | Baseline through End of Study |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriela Chiorean, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| C404768 | vatalanib |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |