A Phase II Trial of TPI 287 in Patients Advanced, Unresectable Pancreatic Cancer
The primary objective of the study is to assess the activity of TPI 287 as single agent therapy for patients with advanced, unresectable pancreatic cancer after failure of gemcitabine-containing therapy. Activity of TPI 287 will be determined by the 6-month survival rate.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Survival [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
- Overall Response Rate [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
- Evaluate time to worsening of clinical status as measured by changes in pain, Karnofsky score, and weight. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
- Response rates and time to progression of tumor marker levels (CA 19-9) [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
- Assess the safety and tolerability of TPI 287 in this patient population [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
- Evaluate outcomes of patient subsets defined by duration of prior gemcitabine therapy [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
- Evaluate the gene expression profile in relation to clinical outcomes [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Study Completion Date:||April 2010|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Drug: TPI 287
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.
|United States, California|
|Desert Hematology Oncology Medical Group, Inc.|
|Rancho Mirage,, California, United States, 92270|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins University|
|Baltimore, Maryland, United States, 21231-1000|
|Center for Cancer and Blood Disorders|
|Bethesda, Maryland, United States, 20817|
|Madrid, Spain, 28250|
|Study Director:||Sandra Silberman, MD||SLS Oncology, LLC|