Status:
COMPLETED
Study of TPI 287 Administered Every 21 Days in Patients With Advanced Malignancies
Lead Sponsor:
Cortice Biosciences, Inc.
Conditions:
Neoplasms
Hodgkin's Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
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 ...
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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00256191
Start Date
November 1 2005
End Date
February 1 2007
Last Update
October 15 2007
Active Locations (1)
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1
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218