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A Phase 1, Open-Label, Q21 Day Dose Escalation, Multi-Center Study of TPI 287 in Patients With Advanced Malignancies


Phase 1
18 Years
85 Years
Not Enrolling
Both
Neoplasms, Hodgkin's Disease, Non-Hodgkin's Lymphoma

Thank you

Trial Information

A Phase 1, Open-Label, Q21 Day Dose Escalation, Multi-Center Study of TPI 287 in Patients With Advanced Malignancies


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose of TPI 287 administered every 21 days

Principal Investigator

Sandra Silberman, MD

Investigator Role:

Study Director

Investigator Affiliation:

Tapestry Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

TPI 287-02

NCT ID:

NCT00256191

Start Date:

November 2005

Completion Date:

February 2007

Related Keywords:

  • Neoplasms
  • Hodgkin's Disease
  • Non-Hodgkin's Lymphoma
  • taxanes
  • multidrug resistance
  • mutant tubulin binding
  • Hodgkin's or Non-Hodgkin's Lymphoma
  • Neoplasms
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Rocky Mountain Cancer Center Denver, Colorado  80218