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A New Agent GM-CT-01 in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00388700
Recruitment Status : Withdrawn (Financing and re-organization)
First Posted : October 17, 2006
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Galectin Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE October 13, 2006
First Posted Date  ICMJE October 17, 2006
Last Update Posted Date February 14, 2018
Study Start Date  ICMJE October 2006
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2012)
Primary Outcomes: Assess the efficacy and safety of GM-CT-01 administered with 5-FU, LV, and Avastin® in the first-line treatment of unresectable, locally advanced, and/or metastatic CRC. [ Time Frame: When 17 evaluable patients will complete the study ]
To assess the clinical benefit of a regimen of GM-CT-01/5-FU, LV plus Avastin® when administered intravenously as a first-line treatment to patients with Stage III or IV ,advanced or metastatic CRC. Clinical activity will be assessed by determining the percentage of subjects exhibiting an objective response (complete response [CR]) plus partial response [PR]). Tumor response will be assessed following Response Evaluation by RECIST guidelines.
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2006)
Primary Outcomes: Assess the efficacy and safety of DAVANAT administered with 5-FU, LV, and Avastin® in the first-line treatment of unresectable, locally advanced, and/or metastatic CRC.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2012)
  • To evaluate the safety of the DAVANAT®/5-FU, LV plus Avastin® regimen. [ Time Frame: Throughout the study and when 17 evaluable patients will when complete the study ]
    Assess safety of regimen and also patient reported outcomes using a Quality of Life (QoL) instrument.
  • Explore progression-free survival (PFS) and survival [ Time Frame: When at least 17 evaluable patients complete the study ]
    To explore time to tumor progression, duration of response and and survival at 6 and 12 months after the first dose of study drug.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A New Agent GM-CT-01 in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer
Official Title  ICMJE Open-Label, Phase 2 Study of GM-CT-01 When Added to a Regimen of Leucovorin, 5-FU, and Avastin as First Line Treatment for Locally Advanced, Unresectable or Metastatic Colorectal Cancer in Subjects Unable to Tolerate Intensive Chemotherapy
Brief Summary The purpose of this clinical trial is to determine whether the combination of 5-fluorouracil (5-FU) plus a DAVANAT (carbohydrate polymer) along with Avastin and Leucovorin (LV) is beneficial in treating colorectal cancer in patients unable to tolerate intensive chemotherapy.
Detailed Description This is a Phase II, multi-center study of DAVANAT which has been shown to increase the anti-tumor activity of 5-FU in mice. 5-FU is a chemotherapy drug commonly used to treat tumors. A Phase I study of 40 patients showed that DAVANAT in different doses plus 5-FU was well tolerated in patients with different types of solid tumors who failed standard, approved treatments.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: GM-CT-01
    On Day 1 and 2 of each cycle, GM-CT-01 280 mg/m2 administered IV over 30 minutes with 5-FU (400 mg/m2), followed by a 22-hour continuous infusion of GM-CT-01 (280 mg/m2) with 5-FU (600 mg/m2 .)
    Other Name: DAVANAT
  • Drug: 5-Fluorouracil, Leukovorin, bevacizumab
    On Day 1 and 2 of each cycle, LV (200 mg/m2) will be administered IV over 2 hours, followed by 5-FU 400 mg/m2 in solution with GM-CT-01 280 mg/m2 administered over 30 minutes, followed by a 22-hour continuous infusion of GM-CT-01 (280 mg/m2) and 5-FU (600 mg/m2 ). on Day 3 Avastin® (5 mg/kg)will be given IV over 30 to 90 minutes per the package insert.
    Other Name: 5-FU, LV, Avastin®
Study Arms  ICMJE Experimental: GM-CT-01
Interventions:
  • Drug: GM-CT-01
  • Drug: 5-Fluorouracil, Leukovorin, bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 13, 2018)
0
Original Enrollment  ICMJE
 (submitted: October 13, 2006)
50
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years or older.
  • Histologically confirmed, unresectable, locally advanced or metastatic colorectal adenocarcinoma (stage III and IV), not amenable to curative surgery or radiotherapy.
  • Intolerant of oxaliplatin and/or irinotecan, as demonstrated by unacceptable toxicity after a trial of these agents as first-line therapy, or in the opinion of the Investigator, be judged at high risk for unacceptable toxicity to oxaliplatin and/or irinotecan,
  • Presence of at least 1 measurable lesion,
  • Have a life expectancy of at least 4 months.
  • Women of childbearing potential, have a negative serum pregnancy test at screening and Day 1 treatment and agree to practice abstinence or use an effective method of contraception.

Exclusion Criteria:

  • Central nervous system metastasis.
  • Bony metastasis as the sole metastasis.
  • Received any prior first-line chemotherapy for colorectal cancer.
  • Previously exposed to DAVANAT® or Avastin®.
  • Known or clinically suspected infection with HIV.
  • Participated within 30 days or will participate concurrently in another investigational drug or vaccine study.
  • History of drug or alcohol dependence in the past 3 years.
  • Other serious, non-malignant, significant, acute or chronic medical or psychiatric illness that in the judgment of the Investigator could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00388700
Other Study ID Numbers  ICMJE DAVFU006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE 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 February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP