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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00256191
• Other study ID #: TPI 287-02
• Status: Completed
• Phase: Phase 1
• First received: November 16, 2005
• Last updated: October 11, 2007
• Start date: November 2005
• Est. completion date: February 2007

Study information

• Verified date: November 2005
• Source: Cortice Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• TPI 287 Injection

Locations

Country	Name	City	State
United States	Rocky Mountain Cancer Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Cortice Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximum tolerated dose of TPI 287 administered every 21 days
Secondary	To determine the safety of TPI 287
Secondary	To determine the antitumor activity of TPI 287
Secondary	To determine the pharmacokinetic profile of TPI 287

External Links

•   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