A Phase 2, Open Label, Single Arm Trial of TPI 287 in Patients With Advanced, Unresectable Pancreatic Cancer After Prior Treatment With a Gemcitabine-based Therapy
This is a multicenter, open-label, single arm Phase 2 study in patients with advanced,
unresectable pancreatic cancer who have received prior gemcitabine-based chemotherapy for
their disease. Patients will receive TPI 287 administered as a 60-minute (± 10 min) IV
infusion.
The primary endpoint of the trial will be the 6-month survival rate. Additional efficacy
endpoints will be response rate, duration of response and stable disease, and 6-month
progression free survival. Responses will be assessed by reduction in radiographically
measurable disease as defined by the RECIST criteria. Time to worsening of clinical status
will be based on reductions in pain and/or analgesic use and changes in tumor markers (CA
19-9) will also be followed.
Patients will remain on study until tumor progression or death, unacceptable toxicity,
withdrawal of consent or discontinuation based on Investigator discretion. Patients will be
followed for survival for up to 1 year after enrollment on the study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival
6 Months
No
Sandra Silberman, MD
Study Director
Archer Biosciences
United States: Food and Drug Administration
TPI 287-06
NCT00553813
October 2007
April 2010
Name | Location |
---|---|
Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
Desert Hematology Oncology Medical Group, Inc. | Rancho Mirage, California 92270 |
Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins University | Baltimore, Maryland 21231-1000 |