Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00099294|
Recruitment Status : Completed
First Posted : December 10, 2004
Last Update Posted : April 30, 2009
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Glufosfamide||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||January 2007|
- 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
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): NCT00099294
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