Colorectal CancerPhase 1NCT00054977
Safety of GM-CT-01 With and Without 5-Fluorouracil in Patients With Solid Tumors
A Phase 1 study testing GM-CT-01 and 5-fluorouracil in people with Colorectal Cancer and Lung Cancer, run by Galectin Therapeutics Inc. at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Lung Cancer, Breast Cancer
- What is being tested?
- GM-CT-01 and 5-fluorouracil
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2003to Sep 2006
- Phase
- Phase 1
- 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
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Florida Oncology Associates
Jacksonville, Florida, 32207
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Ochsner Cancer Institute
New Orleans, Louisiana, 70121
About this study
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
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.
Read the detailed description
5-Fluorouracil is a chemotherapy drug commonly used in cancer patients. Patients with different type of solid tumors who have failed standard, approved treatments can be enrolled in the study. Escalated doses of GM-CT-01 will be given alone in Cycle 1, and in combination with 5-fluorouracil in cycle 2. Patients will be on study for approximately 60 days for determination of safety. However, with patient consent treatment can continue until disease progression is determined by CT scan. The study secondary reason is to determine whether treatment has stabilize the tumors or change it in size (get bigger, smaller or stay the same)after Cycle 2 and any additional cycles of treatment.
- Being tested
- GM-CT-01, 5-fluorouracil
- Keywords
- cancer, tumor
- Medical subject headings
- Colorectal Neoplasms, Lung Neoplasms, Breast Neoplasms, Head and Neck Neoplasms, Prostatic Neoplasms, Neoplasms
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
IV infusion over 30 minutes of 6 Dosages escalated from 30 to 280 mg/m2, given for 4 consecutive days in a 28 days cycle.
5-fluorouracilDrug
Also called 5-FU
IV infusion over 30 minutes at Dosage of 500 mg/m2, given in-combination with GM-CT-01, for 4 consecutive days in a 28 days cycle.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: 60 days - two cycles of treatment
Secondary outcomes (1)
Tumor progression
Measured: CT imaging at 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2003 (estimated)
- Study startFeb 2003
- Primary completionApr 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galectin Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marilyn C Pike, M.D., Ph.D., Study director, Consultant to Pro-Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00054977
- Sponsor's protocol ID
- DAVFU-001
- Status last verified
- Mar 2012
- First submitted
- 14 Feb 2003
- Last updated
- 12 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00054977
- Acronym / sponsor ID
- DAVFU-001
- Keywords
- cancer, tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Galectin Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Apr 2005 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 17 Feb 2003 (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.
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.
Detailed description
5-Fluorouracil is a chemotherapy drug commonly used in cancer patients. Patients with different type of solid tumors who have failed standard, approved treatments can be enrolled in the study. Escalated doses of GM-CT-01 will be given alone in Cycle 1, and in combination with 5-fluorouracil in cycle 2. Patients will be on study for approximately 60 days for determination of safety. However, with patient consent treatment can continue until disease progression is determined by CT scan. The study secondary reason is to determine whether treatment has stabilize the tumors or change it in size (get bigger, smaller or stay the same)after Cycle 2 and any additional cycles of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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: DAVANATIV infusion over 30 minutes of 6 Dosages escalated from 30 to 280 mg/m2, given for 4 consecutive days in a 28 days cycle. | Drug | – |
| 5-fluorouracilAlso: 5-FUIV infusion over 30 minutes at Dosage of 500 mg/m2, given in-combination with GM-CT-01, for 4 consecutive days in a 28 days cycle. | Drug | – |
Primary outcome
Safety
Time frame: 60 days - two cycles of treatment
1 secondary outcome
Tumor progression
Time frame: CT imaging at 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2012.
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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.
Marilyn C Pike, M.D., Ph.D. study director
Consultant to Pro-Pharmaceuticals, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GM-CT-01 and 5-fluorouracil in people with Colorectal Cancer and Lung Cancer, run by Galectin Therapeutics Inc. at 4 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 15 inclusion and 8 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: finished, as of the sponsor's last update on 12 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety (time frame: 60 days - two cycles of treatment). 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 12 Mar 2012.