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

This study has been completed.
Sponsor:
Information provided by:
Cortice Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00256191
First received: November 16, 2005
Last updated: October 11, 2007
Last verified: November 2005
  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

Cortice 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

Resource links provided by NLM:


Further study details as provided by Cortice Biosciences, Inc.:

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

Estimated Enrollment: 45
Study Start Date: November 2005
Study Completion Date: February 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256191

Locations
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
Sponsors and Collaborators
Cortice Biosciences, Inc.
Investigators
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 Cortice Biosciences, Inc.:
taxanes
multidrug resistance
mutant tubulin binding
Hodgkin's or Non-Hodgkin's Lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014