Breast Cancer Clinical Trial
Official title:
A Phase I Open-Label Study to Evaluate the Safety and Tolerability of Escalating Doses of GM-CT-01 in the Presence and Absence of 5-Fluorouracil (5-FU) in Subjects With Advanced Solid Tumors
Verified date | March 2012 |
Source | Galectin Therapeutics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This is a Phase I, multi-center study of GM-CT-01, which has been shown to increase the anti-tumor activity of 5-fluorouracil in mice. The primary reason for doing the study is to determine the safety of GM-CT-01 given alone and in combination with therapeutical dosage of 5-Fluorouracil, in patients who have advanced cancer that can be measured by CT scan.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 2006 |
Est. primary completion date | April 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - The subject is able to give informed consent to participate in this trial (including all procedures and follow-up visits). - The subject is male or female at least 18 years of age. - The subject has a documented histologic or cytologic recurrent or metastatic solid tumor that is not amenable to curative surgery, radiotherapy, or conventional chemotherapy of proven value. - Subjects must have completed previous therapy (chemotherapeutic agents or other therapies including radiation) at least 4 weeks prior to study entry. - Following major surgery (e.g. laparotomy), > 4 weeks must have elapsed and subjects must have recovered from effects. - Following minor surgery (does not include insertion of vascular access device), > 2 weeks must have elapsed. - ECOG performance status of 0-2. - The subject has a life expectancy of at least 12 weeks. - Female subjects must be post-menopausal, surgically sterile, or using effective contraception. Laboratory values prior to administration of study drug: - If female and not post-menopausal, the subject has a negative pregnancy test. - Liver function studies: AST and ALT < 2.5 times the upper limit of normal (ULN); total bilirubin < 1.5 - Hematopoietic parameters: WBC > 3000 per mm3; Granulocyte count > 1,500 per mm3; Platelet count > 100,000 per mm3 - Renal: Creatinine < or = ULN - Pulmonary: Dlco > or = 60% of predicted Exclusion Criteria: - If female, the subject is pregnant or breast feeding. - Central nervous system (CNS) metastases or primary CNS tumors. - The subject has a known hypersensitivity to GM-CT-01 or any of its components. - The subject has congestive heart failure or any other medical condition that could be adversely affected by intravenous infusion of up to approximately 200 mL of fluid over 60 minutes. - The subject is currently abusing alcohol and/or illicit drugs. - The subject has other significant medical, psychiatric, or social conditions which, in the investigators' opinion, may compromise the subject's safety in participating in this study. - In the investigators' judgment, the subject would be unreliable in adhering to the study visit schedule or other study requirements. - The subject is currently enrolled in a clinical trial or has participated in a clinical trial within the 30 days prior to entry into this study. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Florida Oncology Associates | Jacksonville | Florida |
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Ochsner Cancer Institute | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Galectin Therapeutics Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | 60 days - two cycles of treatment | Yes | |
Secondary | Tumor progression | CT imaging at 60 days | No |
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