Cancer of the Bile DuctPhase 2NCT00386516
Study to Test the Benefit and Safety of GM-CT-01 in Combination With 5-FU to Treat Bile Duct and Gall Bladder Cancer
A Phase 2 study testing GM-CT-01 and 5-Fluorouracil in people with Cancer of the Bile Duct and Gallbladder Cancer, run by Galectin Therapeutics Inc. at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Bile Duct, Gallbladder Cancer
- What is being tested?
- GM-CT-01 and 5-Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2006to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- 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.
- 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.
- 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.
- Prior surgery must have been completed at least 14 days prior to Day 1 of Cycle 1.
- 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.
- ECOG performance status less than or equal to 2.
- Life expectancy greater or equal to 3 months.
Who cannot join
- Central nervous system metastasis.
- Bony metastasis as the sole metastasis.
- 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.
- 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.
- Active infection that requires treatment with systemic antibiotic, anti- fungal. or anti-viral therapy.
- 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.
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- Unresolved biliary tract obstruction.
- Known or clinically suspected infection with HIV.
- Subject has a known intolerance to 5- FU.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan, Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Boston Medical Center
Boston, Massachusetts, 02118
Barrett Cancer Center
Cincinnati, Ohio, 45267-0501
About this study
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
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.
Read the 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.
- Conditions
- Cancer of the Bile Duct, Gallbladder Cancer
- Being tested
- GM-CT-01, 5-Fluorouracil
- Keywords
- cholangiocarcinoma, bile duct, biliary, intra-hepatic, extra-hepatic, gall bladder, cancer, carcinoma, metastatic, metastasis, advanced, recurrent
- Medical subject headings
- Bile Duct Neoplasms, Gallbladder Neoplasms, Cholangiocarcinoma, Neoplasms, Carcinoma, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-CT-01Drug
Also called DAVANAT
GM-CT-01 at 280 mg/m2 given IV for 4 consecutive days in 28 days cycle until disease progression
5-FluorouracilDrug
Also called 5-FU
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
| Study group | Role | What they receive |
|---|---|---|
| GM-CT-01, 5-FU | Experimental | 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. Receives: Drug: GM-CT-01; Drug: 5-Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) defined as complete response (CR) rate plus partial response (PR) rate using Response Evaluation Criteria in Solid Tumors (RECIST)
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.
Measured: When 18 valuable patients have completed 2nd CT
Stable disease (SD) rate and progression-free survival (PFS) times
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.
Measured: When 18 valuable patients have completed 2nd CT
Secondary outcomes (1)
Safety, tolerability and Quality of Life (QoL)
Measured: Any patient completed a drug treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: Financing and re-organization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the Bile DuctStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galectin Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386516
- Sponsor's protocol ID
- DAVFU-007
- Status last verified
- Aug 2014
- First submitted
- 10 Oct 2006
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00386516
- Acronym / sponsor ID
- DAVFU-007
- Conditions
- Cancer of the Bile Duct, Gallbladder Cancer
- Keywords
- cholangiocarcinoma, bile duct, biliary, intra-hepatic, extra-hepatic, gall bladder, cancer, carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Financing and re-organization
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Galectin Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 11 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GM-CT-01, 5-FU | Experimental | Drug: GM-CT-01, Drug: 5-FluorouracilGM-CT-01 (280 mg/m2) combined with 5-FU (600 mg/m2) given 4 consecutive days in a 28 days cycle until disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or older.
- 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.
- 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.
- 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.
- Prior surgery must have been completed at least 14 days prior to Day 1 of Cycle 1.
Key exclusion criteria (9 listed)
- Central nervous system metastasis.
- Bony metastasis as the sole metastasis.
- 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.
- 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.
- Active infection that requires treatment with systemic antibiotic, anti- fungal. or anti-viral therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GM-CT-01Also: DAVANATGM-CT-01 at 280 mg/m2 given IV for 4 consecutive days in 28 days cycle until disease progression | Drug | GM-CT-01, 5-FU |
| 5-FluorouracilAlso: 5-FU5-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 | Drug | GM-CT-01, 5-FU |
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.
1 secondary outcome
Safety, tolerability and Quality of Life (QoL)
Time frame: Any patient completed a drug treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GM-CT-01 and 5-Fluorouracil in people with Cancer of the Bile Duct and Gallbladder Cancer, run by Galectin Therapeutics Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017; AzTrials last refreshed its copy on 7 Nov 2026.