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Sponsored by: |
Archer Biosciences, Inc. |
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Information provided by: | Archer Biosciences, Inc. |
ClinicalTrials.gov Identifier: | NCT00256191 |
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.
Condition | Intervention | Phase |
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Neoplasms Hodgkin's Disease Non-Hodgkin's Lymphoma |
Drug: TPI 287 Injection |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1, Open-Label, Q21 Day Dose Escalation, Multi-Center Study of TPI 287 in Patients With Advanced Malignancies |
Estimated Enrollment: | 45 |
Study Start Date: | November 2005 |
Study Completion Date: | February 2007 |
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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must be/have:
Exclusion Criteria:
Patients will be excluded if they are or have had:
United States, Colorado | |
Rocky Mountain Cancer Center | |
Denver, Colorado, United States, 80218 |
Study Director: | Sandra Silberman, MD | Tapestry Pharmaceuticals, Inc. |
Study ID Numbers: | TPI 287-02 |
Study First Received: | November 16, 2005 |
Last Updated: | October 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00256191 History of Changes |
Health Authority: | United States: Food and Drug Administration |
taxanes multidrug resistance mutant tubulin binding Hodgkin's or Non-Hodgkin's Lymphoma |
Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Immunoproliferative Disorders Hodgkin Lymphoma, Adult Hodgkin's Disease |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Taxane Hodgkin Disease Lymphoma |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Hodgkin Disease |