Clinical Trial: Study to Test the Benefit and Safety of GM-CT-01 in Combination With 5-FU to Treat Bile Duct and Gall Bladder Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase 2, Multi-center, Open-label Trial to Evaluate Efficacy and Safety of GM-CT-01 in Combination With 5-FU as First Line Chemotherapy in Patients With Advanced Biliary Cancer

Brief 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.

Detailed Summary: 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.
Sponsor: Galectin Therapeutics Inc.

Current Primary Outcome:

  • Objective response rate (ORR) defined as complete response (CR) rate plus partial response (PR) rate using Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: When 18 valuable patients have completed 2nd CT ]
    A minimum of 18 subjects who meet the response evaluation criteria (per protocol population) will be enrolled in Stage 1. This require 2nd CT evaluation of tumor after minimum 2 cycles of treatments. CR, PR, SD and progressive disease (PD) as defined by RECIST criteria.
  • Stable disease (SD) rate and progression-free survival (PFS) times [ Time Frame: When 18 valuable patients have completed 2nd CT ]
    A minimum of 18 subjects who meet the response evaluation criteria (per protocol population) will be enrolled in Stage 1. This require 2nd CT evaluation of tumor after minimum 2 cycles of treatments. SD and progressive disease (PD) as defined by RECIST criteria.


Original Primary Outcome:

  • Objective response rate (ORR) defined as complete response (CR) rate plus partial response (PR) rate using Response Evaluation Criteria in Solid Tumors (RECIST)
  • Stable disease (SD) rate


Current Secondary Outcome: Safety, tolerability and Quality of Life (QoL) [ Time Frame: Any patient completed a drug treatment ]

Original Secondary Outcome:

  • Overall and progression-free survival (PFS) times
  • Quality of Life (QoL)
  • Safety and tolerability


Information By: Galectin Therapeutics Inc.

Dates:
Date Received: October 10, 2006
Date Started: September 2006
Date Completion:
Last Updated: August 8, 2016
Last Verified: August 2014