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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TPI 287 Injection
Sponsored by
Cortice Biosciences, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms focused on measuring taxanes, multidrug resistance, mutant tubulin binding, Hodgkin's or Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rocky Mountain Cancer Center

Outcomes

Primary Outcome Measures

To determine the maximum tolerated dose of TPI 287 administered every 21 days

Secondary Outcome Measures

To determine the safety of TPI 287
To determine the antitumor activity of TPI 287
To determine the pharmacokinetic profile of TPI 287

Full Information

First Posted
November 16, 2005
Last Updated
October 11, 2007
Sponsor
Cortice Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00256191
Brief Title
Study of TPI 287 Administered Every 21 Days in Patients With Advanced Malignancies
Official Title
A Phase 1, Open-Label, Q21 Day Dose Escalation, Multi-Center Study of TPI 287 in Patients With Advanced Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cortice Biosciences, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Hodgkin's Disease, Non-Hodgkin's Lymphoma
Keywords
taxanes, multidrug resistance, mutant tubulin binding, Hodgkin's or Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
TPI 287 Injection
Primary Outcome Measure Information:
Title
To determine the maximum tolerated dose of TPI 287 administered every 21 days
Secondary Outcome Measure Information:
Title
To determine the safety of TPI 287
Title
To determine the antitumor activity of TPI 287
Title
To determine the pharmacokinetic profile of TPI 287

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Silberman, MD
Organizational Affiliation
Tapestry Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.tapestrypharma.com
Description
Click here for more information about this study. A Phase 1, Open-Label, Q21 Day Dose Escalation, Multi-Center Study of TPI 287 in Patients with Advanced Malignancies

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

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