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GM-CT-01

Phase 2

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

GM-CT-01 development status

Highest phase Phase 2 (NCT00386516)
Phase scored for GALTPhase 1
Registered trials 3 across 1 sponsor since Feb 2003

GM-CT-01 target and mechanism

Molecular targetgalectin-3
Target classProtein
ModalitySmall molecule

Also known as DAVANAT

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

GM-CT-01 clinical trials

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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Competitive Landscape -Colorectal Cancer 361 trials

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Frequently asked questions about GM-CT-01

What is GM-CT-01 used for?

GM-CT-01 is being studied in colorectal cancer and other solid tumors. It was evaluated in a Phase 1 trial that enrolled patients with colorectal, lung, breast, head and neck, and prostate cancers. It is an investigational agent and is not approved for commercial use.

What does GM-CT-01 target?

GM-CT-01 targets galectin-3, a protein involved in tumor progression and immune regulation. By binding galectin-3, the small molecule is designed to interfere with galectin-3 mediated processes in cancer cells. This mechanism is being explored in solid tumor settings.

Who is developing GM-CT-01?

GM-CT-01 is being developed by Galectin Therapeutics Inc., a company traded on the Nasdaq under the ticker GALT. The company focuses on galectin-targeted therapies, and GM-CT-01 is one of its clinical-stage assets.

What phase is GM-CT-01 in?

GM-CT-01 is in Phase 1 development. It has completed one Phase 1 clinical trial in patients with solid tumors. The drug remains investigational and has not been approved by the FDA for any indication.

What clinical trials is GM-CT-01 in?

GM-CT-01 has been studied in a single completed Phase 1 trial, NCT00054977, titled Safety of GM-CT-01 With and Without 5-Fluorouracil in Patients With Solid Tumors. The trial enrolled 40 patients in the United States and evaluated safety in colorectal cancer and other solid tumors.