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Tapestry Pharmaceuticals, Inc. has developed a novel taxane analog, TPI 287. TPI 287 is synthetically manufactured from naturally occurring taxanes extracted from yew starting material. The synthesis involves modification to the taxane side chain to overcome multidrug resistance and to achieve mutant tubulin binding. This study will be a multi-center, dose escalation, sequential group, Phase 1 study evaluating the intravenous administration of TPI 287 on an every 21 day cycle.
The primary objective of this study is to determine the maximum tolerated dose of TPI 287 administered every 21 days for Phase II clinical trials.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPI 287 Injection | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the maximum tolerated dose of TPI 287 administered every 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety of TPI 287 | ||
| To determine the antitumor activity of TPI 287 | ||
| To determine the pharmacokinetic profile of TPI 287 |
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Inclusion Criteria:
Patients must be/have:
Exclusion Criteria:
Patients will be excluded if they are or have had:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Silberman, MD | Tapestry Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C578069 | TPI-287 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |