A Phase II Trial of TPI 287 in Patients Advanced, Unresectable Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00553813|
Recruitment Status : Terminated (Insufficient funding)
First Posted : November 6, 2007
Last Update Posted : January 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: TPI 287||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||April 2010|
- Drug: TPI 287
Intravenous dose of 125 mg/m2 TPI 287 on Day 1, Day 8, and Day 15 in a repeating 28 day cycle.
- Survival [ Time Frame: 6 Months ]
- Overall Response Rate [ Time Frame: Ongoing ]
- Evaluate time to worsening of clinical status as measured by changes in pain, Karnofsky score, and weight. [ Time Frame: Ongoing ]
- Response rates and time to progression of tumor marker levels (CA 19-9) [ Time Frame: Ongoing ]
- Assess the safety and tolerability of TPI 287 in this patient population [ Time Frame: Ongoing ]
- Evaluate outcomes of patient subsets defined by duration of prior gemcitabine therapy [ Time Frame: Ongoing ]
- Evaluate the gene expression profile in relation to clinical outcomes [ Time Frame: Ongoing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553813
|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|