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
Overview
- Phase
- Phase 2
- Intervention
- GM-CT-01
- Conditions
- Colorectal Cancer
- Sponsor
- Galectin Therapeutics Inc.
- Locations
- 4
- Primary Endpoint
- 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.
- Status
- Withdrawn
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
GM-CT-01
Intervention: GM-CT-01
GM-CT-01
Intervention: 5-Fluorouracil, Leukovorin, bevacizumab
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Explore progression-free survival (PFS) and survival(When at least 17 evaluable patients complete the study)
- To evaluate the safety of the DAVANAT®/5-FU, LV plus Avastin® regimen.(Throughout the study and when 17 evaluable patients will when complete the study)