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GM-CT-01

Phase 1

Colorectal Cancer | Small molecule | Oncology |Galectin Therapeutics Inc.|Last Updated: Mar 12, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

GM-CT-01 · 1 trial · 5 indications

Phase 1 1
NCT00054977Safety of GM-CT-01 With and Without 5-Fluorouracil in Patients With Solid TumorsColorectal Cancer
COMPLETED40 Analytics
PHASE1COMPLETED
Safety of GM-CT-01 With and Without 5-Fluorouracil in Patients With Solid Tumors
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety
60 days - two cycles of treatment

Secondary Endpoints

Tumor progression
CT imaging at 60 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
GM-CT-01DRUGIV 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-fluorouracilDRUGIV 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

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 ...

Countries:United States
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Frequently asked questions about GM-CT-01

What is GM-CT-01 used for?

GM-CT-01 is an investigational small molecule being studied for the treatment of colorectal cancer. It is also being evaluated in patients with lung cancer, breast cancer, head and neck cancer, and prostate cancer. GM-CT-01 is in Phase 1 clinical development and is not yet approved by the FDA.

What does GM-CT-01 target?

The molecular target of GM-CT-01 has not been disclosed. It is a small molecule being developed by Galectin Therapeutics Inc. for oncology indications, including colorectal cancer. The drug is currently in Phase 1 clinical trials to evaluate its safety and tolerability.

Who makes GM-CT-01?

GM-CT-01 is being developed by Galectin Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GALT. The company is conducting clinical research on this investigational small molecule for the treatment of solid tumors, including colorectal cancer.

What phase is GM-CT-01 in?

GM-CT-01 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, which enrolled 40 patients with various solid tumors, including colorectal cancer.

What clinical trials is GM-CT-01 in?

GM-CT-01 has one completed clinical trial, identified as NCT00054977, titled 'Safety of GM-CT-01 With and Without 5-Fluorouracil in Patients With Solid Tumors.' This Phase 1 study enrolled 40 patients in the United States and included conditions such as colorectal cancer, lung cancer, breast cancer, head and neck cancer, and prostate cancer.

Is GM-CT-01 the same as any other drug?

No alternative names for GM-CT-01 have been disclosed. It is a distinct investigational small molecule developed by Galectin Therapeutics Inc. for oncology indications. The drug is currently in Phase 1 clinical development and has not been approved for any use.