Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer
The primary objectives of the study is to evaluate the effectiveness and safety of glufosfamide in subjects with pancreatic cancer who have been previously treated with gemcitabine as measured by overall survival compared with best supportive care.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine|
- Overall Survival
- Objective tumor response rate
- Duration of objective tumor response rate
- Progression-free survival
- 6 month and 12 month survival
- Serum CA 19-9
- Pain Intensity
- Performance Status
|Study Start Date:||September 2004|
|Study Completion Date:||January 2007|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
TH-CR-302 is a randomized Phase 3 study that will evaluate the efficacy and safety of glufosfamide plus best supportive care (BSC) compared to BSC alone for second line treatment of metastatic pancreatic cancer. BSC includes all medical or surgical interventions that a pancreatic cancer patient should receive to palliate the cancer but excludes treatment with systemic therapies intended to kill the cancer cells.
Study Hypothesis: Glufosfamide will provide benefits in survival to patients with metastatic pancreatic cancer over best supportive care.
Comparison: Glufosfamide versus best supportive care.
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