Clinical trial NCT00256191: Study of TPI 287 Administered Every 21 Days in Patients With Advanced Malignancies
Official title: A Phase 1, Open-Label, Q21 Day Dose Escalation, Multi-Center Study of TPI 287 in Patients With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Hodgkin's Disease
Non-Hodgkin's Lymphoma
Keywords: taxanes
multidrug resistance
mutant tubulin binding
Hodgkin's or Non-Hodgkin's Lymphoma
Lead sponsor: Cortice Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2005-11-21
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: To determine the maximum tolerated dose of TPI 287 administered every 21 days
Secondary outcomes:
measure: To determine the safety of TPI 287
measure: To determine the antitumor activity of TPI 287
measure: To determine the pharmacokinetic profile of TPI 287
Other outcomes:
Locations:
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
Study officials:
affiliation: Tapestry Pharmaceuticals, Inc.
name: Sandra Silberman, MD
role: STUDY_DIRECTOR
References: