Study of TPI 287 Administered Every 21 Days in Patients With Advanced Malignancies
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|---|---|
|
Neoplasms Hodgkin's Disease Non-Hodgkin's Lymphoma |
Drug: TPI 287 Injection |
Phase 1 |
Archer Biosciences, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1, Open-Label, Q21 Day Dose Escalation, Multi-Center Study of TPI 287 in Patients With Advanced Malignancies |
- To determine the maximum tolerated dose of TPI 287 administered every 21 days
- To determine the safety of TPI 287
- To determine the antitumor activity of TPI 287
- To determine the pharmacokinetic profile of TPI 287
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must be/have:
- Histological evidence of malignancy
- Advanced solid tumors that have recurred or progressed following standard therapy
- Failed one prior therapy or have no standard therapy available
- Ambulatory with ECOG of 0-1 and estimated life expectancy of > 3 months
- If female, negative pregnancy test
- If of childbearing years, agree to use birth control
- If patient with prior radiation therapy for brain metastases, on steroids, must have been stable for 1 month
Exclusion Criteria:
Patients will be excluded if they are or have had:
- Prior radiation within 4 weeks
- Active medical condition or organ disease which may compromise safety or interfere with the study
- Clinically significant cardiac co-morbidities or pulmonary impairment
- Concomitant therapy needs
- Treated with any investigational drugs within 30 days
- Tumors involve major artery or vein
- Prior or concurrent central nervous system (CNS) disease
- Less than 4 weeks since major surgery
- Known to be positive for HIV, hepatitis B or C
- Concurrent use of aspirin
- Use of thrombolytic agents
- Uncontrolled hypertension
- Grade II-IV peripheral vascular disease
- Pregnant or lactating
- Prior allergic history to compounds of similar chemical composition
- Inpatients
- Grade II-IV peripheral neuropathy
Contacts and Locations| United States, Colorado | |
| Rocky Mountain Cancer Center | |
| Denver, Colorado, United States, 80218 | |
| Study Director: | Sandra Silberman, MD | Tapestry Pharmaceuticals, Inc. |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00256191 History of Changes |
| Other Study ID Numbers: | TPI 287-02 |
| Study First Received: | November 16, 2005 |
| Last Updated: | October 11, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Archer Biosciences, Inc.:
|
taxanes multidrug resistance mutant tubulin binding Hodgkin's or Non-Hodgkin's Lymphoma |
Additional relevant MeSH terms:
|
Neoplasms Hodgkin Disease Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013