Study of TPI 287 Administered Every 21 Days in Patients With Advanced Malignancies

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 1, Open-Label, Q21 Day Dose Escalation, Multi-Center Study of TPI 287 in Patients With Advanced Malignancies

Conditions
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Neoplasms, Hodgkin's Disease, Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: TPI 287 Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TPI 287 Injection|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the maximum tolerated dose of TPI 287 administered every 21 days |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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taxanes, multidrug resistance, mutant tubulin binding, Hodgkin's or Non-Hodgkin's Lymphoma