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Clinical Trial Summary

The purpose of this clinical trial is to determine whether the combination of the established chemotherapeutic agent 5-fluorouracil(5-FU) and the large carbohydrate molecule GM-CT-01 is beneficial in treating advanced gall bladder and bile duct cancer.


Clinical Trial Description

Determine the overall response rate (ORR) defined as complete response (CR)rate plus partial response (PR) rate using Response Evaluation Criteria in Solid Tumors (RECIST), as well as the stable disease (SD) rate in subjects with unresectable, locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors treated with GM-CT-01 plus 5-Fluorouracil (DAVFU) at doses of 280 mg/m2 and 600 mg/m2, respectively, during cycles of 4 consecutive days of treatment followed by a 24-day follow-up period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00386516
Study type Interventional
Source Galectin Therapeutics Inc.
Contact
Status Withdrawn
Phase Phase 2
Start date September 2006
Completion date June 2009

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