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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-02-28

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.

Conditions

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Neoplasms Hodgkin's Disease Non-Hodgkin's Lymphoma

Keywords

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taxanes multidrug resistance mutant tubulin binding Hodgkin's or Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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TPI 287 Injection

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Sandra Silberman, MD

Role: STUDY_DIRECTOR

Tapestry Pharmaceuticals, Inc.

Locations

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Rocky Mountain Cancer Center

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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TPI 287-02

Identifier Type: -

Identifier Source: org_study_id