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.
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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
NeoplasmsHodgkin's DiseaseNon-Hodgkin's Lymphoma
Drug: TPI 287 Injection
Cortice Biosciences, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
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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Ages Eligible for Study:
18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
Grade II-IV peripheral vascular disease
Pregnant or lactating
Prior allergic history to compounds of similar chemical composition