GM-CT-01 Plus 5-Fluorouracil as Third- or Fourth-Line Therapy for Metastatic Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT00110721 |
Recruitment Status
:
Terminated
(Study protocol amended to a new treatment regimen: study DAVFU-006.)
First Posted
: May 13, 2005
Last Update Posted
: March 6, 2012
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Sponsor:
Galectin Therapeutics Inc.
Information provided by (Responsible Party):
Galectin Therapeutics Inc.
Tracking Information | |||
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First Submitted Date ICMJE | May 12, 2005 | ||
First Posted Date ICMJE | May 13, 2005 | ||
Last Update Posted Date | March 6, 2012 | ||
Study Start Date ICMJE | May 2005 | ||
Actual Primary Completion Date | June 2007 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00110721 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE |
safety of GM-CT-01 plus 5-FU [ Time Frame: 20 patients completed treatment ] Frequency and type of AE/SAE and ancillary clinical indicators including Eastern Cooperative Oncology Group (ECOG) performance and quality of life.
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | GM-CT-01 Plus 5-Fluorouracil as Third- or Fourth-Line Therapy for Metastatic Colorectal Cancer | ||
Official Title ICMJE | A Phase II, Multi-Center, Open-Label Trial to Evaluate the Efficacy and Safety of Intravenous GM-CT-01 in Combination With 5-Fluorouracil When Administered in Monthly Cycles as Third- or Fourth-Line Therapy for Metastatic Colorectal Cancer | ||
Brief Summary | This is a Phase II, multi-center study of GM-CT-01 which has been shown to increase the anti-tumor activity of 5-fluorouracil (5-FU) in mice. 5-FU is a chemotherapy drug commonly used in cancer patients. In this Phase II study, patients with colon cancer which has spread, despite treatment with approved therapies, will receive GM-CT-01 plus 5-FU in monthly cycles for at least 2 cycles or until their disease progresses. | ||
Detailed Description | A Phase I study of 40 patients showed that GM-CT-01 in different doses plus 5-FU was well tolerated in patients with different types of solid tumors who failed standard, approved treatments. The main reason for doing this Phase II study in advanced colorectal cancer patients is to verify the safety observations in the early Phase I study and further evaluate the efficacy of these drugs' combination to stabilize tumors, preventing further growth and potentially shrink tumors. | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 2 | ||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Colorectal Cancer | ||
Intervention ICMJE | Drug: GM-CT-01 plus 5-Fluorouracil
Single use vials, combined regimen of GM-CT-01 / 5-Fluorouracil (280 mg/m2 /500 mg/m2) given for 4 consecutive days in a 28 day cycle until disease progression.
Other Name: DAVANAT |
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Study Arms | Not Provided | ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Terminated | ||
Actual Enrollment ICMJE |
20 | ||
Original Enrollment ICMJE |
33 | ||
Actual Study Completion Date | February 2008 | ||
Actual Primary Completion Date | June 2007 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
The same diagnostic imaging method must be used throughout the study to evaluate the lesions; and clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes).
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Israel, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00110721 | ||
Other Study ID Numbers ICMJE | DAVFU-003 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Galectin Therapeutics Inc. | ||
Study Sponsor ICMJE | Galectin Therapeutics Inc. | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Galectin Therapeutics Inc. | ||
Verification Date | March 2012 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |