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

July 31, 2017 updated by: Galectin Therapeutics Inc.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan, Comprehensive Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0501
        • Barrett Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 years of age or older.
  2. Histologically or cytologically documented carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder with clinical and/or radiologic evidence of unresectable, locally advanced or metastatic disease.
  3. Prior neo-adjuvant or adjuvant therapy (including radiation therapy) is allowed provided it was completed at least 4 weeks before documented disease recurrence or metastasis.
  4. Discontinuation of radiation therapy at least 3 weeks prior to Day 1 of Cycle 1. Radiation therapy will not be allowed while a subject is on study except for palliative radiation therapy to non-target lesions administered following consultation with the Medical Monitor.
  5. Prior surgery must have been completed at least 14 days prior to Day 1 of Cycle 1.
  6. Nne or more measurable target lesion(s) according to RECIST. Measurable lesion(s) must be outside of previous radiation field or demonstrate clear radiographic progression on serial imaging if within previous treatment field.
  7. ECOG performance status less than or equal to 2.
  8. Life expectancy greater or equal to 3 months.

Exclusion Criteria:

  1. Central nervous system metastasis.
  2. Bony metastasis as the sole metastasis.
  3. Received prior chemotherapy or anti-angiogenesis agents including bevacizumab or erbitux or radiation therapy other than in a neo-adjuvant or adjuvant setting. No concomitant chemotherapy, anti-tumor biologic therapy, or radiation therapy is allowed.
  4. If nitrosoureas or mitomycin C were used as neo-adjuvant or adjuvant therapy, then at least 6 weeks should have elapsed prior to treatment with DAVFU.
  5. Active infection that requires treatment with systemic antibiotic, anti- fungal. or anti-viral therapy.
  6. Congestive heart failure (Class III or IV in the NYHA functional classification system) or any other medical condition that would preclude the IV administration of up to approximately 200 mL of fluid over 30-60 minutes.
  7. Unresolved biliary tract obstruction.
  8. Known or clinically suspected infection with HIV.
  9. Subject has a known intolerance to 5- FU.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GM-CT-01, 5-FU
GM-CT-01 (280 mg/m2) combined with 5-FU (600 mg/m2) given 4 consecutive days in a 28 days cycle until disease progression.
Drug: GM-CT-01
GM-CT-01 at 280 mg/m2 given IV for 4 consecutive days in 28 days cycle until disease progression
Other Names:
  • DAVANAT
Drug: 5-Fluorouracil
5-FU given IV by infusion for 30, at 600 mg/m2 in combination with GM-CT-01 for 4 consecutive days in 28 days cycle until disease progression
Other Names:
  • 5-FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
When 18 valuable patients have completed 2nd CT
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.
When 18 valuable patients have completed 2nd CT

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galectin Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

October 10, 2006

First Submitted That Met QC Criteria

October 10, 2006

First Posted (ESTIMATE)

October 11, 2006

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 31, 2017

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAVFU-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gallbladder Cancer

Clinical Trials on GM-CT-01

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe