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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00256191
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : October 15, 2007
Information provided by:
Cortice Biosciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Neoplasms Hodgkin's Disease Non-Hodgkin's Lymphoma Drug: TPI 287 Injection Phase 1

Expanded Access : Cortice Biosciences, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2005
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To determine the maximum tolerated dose of TPI 287 administered every 21 days

Secondary Outcome Measures :
  1. To determine the safety of TPI 287
  2. To determine the antitumor activity of TPI 287
  3. To determine the pharmacokinetic profile of TPI 287

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00256191

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United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
Sponsors and Collaborators
Cortice Biosciences, Inc.
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Study Director: Sandra Silberman, MD Tapestry Pharmaceuticals, Inc.
Additional Information:
Layout table for additonal information Identifier: NCT00256191    
Other Study ID Numbers: TPI 287-02
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: October 15, 2007
Last Verified: November 2005
Keywords provided by Cortice Biosciences, Inc.:
multidrug resistance
mutant tubulin binding
Hodgkin's or Non-Hodgkin's Lymphoma
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases