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PELITREXOL/AG-2037

Phase 2

Colorectal Neoplasms | Small molecule | Oncology |Pfizer, Inc.|Trials Updated: Nov 9, 2006

PELITREXOL/AG-2037 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Mar 2004

PELITREXOL/AG-2037 target and mechanism

Molecular targetGART
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

PELITREXOL/AG-2037 clinical trials

PELITREXOL/AG-2037 · 1 trial · 1 indication

Phase 2 1
NCT00078468Study of the GARFT Inhibitor AG2037 in Patients With Metastatic Colorectal Cancer Who Failed TreatmentColorectal Neoplasms
COMPLETED56 Analytics
PHASE2COMPLETED
Study of the GARFT Inhibitor AG2037 in Patients With Metastatic Colorectal Cancer Who Failed Treatment
Colorectal NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the overall objective response rate (complete and partial responses) of AG-2037 in patients with metastatic colorectal cancer who failed treatment with 5FU/LV regimen and up to one other chemotherapeutic regimen.

Secondary Endpoints

To estimate time to progression (TTP).
To evaluate the overall survival (1-year) of patients treated with AG-2037.
To assess changes in patient reported outcomes using health-related quality of life questionnaires.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
PELITREXOL/AG-2037DRUG -
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Eligibility Criteria

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

Inclusion Criteria: * Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum * Stage IV or recurrent disease * Measurable disease * Disease progression or recurrence during or after completion of prior first-line chemotherapy with fluorouracil and leucovorin calc...

Countries:United States
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Frequently asked questions about PELITREXOL/AG-2037

What is PELITREXOL/AG-2037?

PELITREXOL/AG-2037 is an investigational small molecule developed by Pfizer, Inc. (ticker: PFE) for the treatment of colorectal neoplasms. It is a GART inhibitor that has been studied in patients with metastatic colorectal cancer. The drug remains in clinical development and is not approved for commercial use.

What is PELITREXOL/AG-2037 used for?

PELITREXOL/AG-2037 has been studied for colorectal neoplasms, specifically in patients with metastatic colorectal cancer who failed prior treatment. Its only recorded clinical trial enrolled adults with this condition. The asset is investigational and has not been approved for any indication.

What does PELITREXOL/AG-2037 target?

PELITREXOL/AG-2037 targets GART, also known as glycinamide ribonucleotide transformylase. It acts as an inhibitor of this enzyme. GART is involved in purine biosynthesis, and inhibiting it is the intended mechanism of action for this small molecule in colorectal cancer research.

Who makes PELITREXOL/AG-2037?

Pfizer, Inc. is the developer of PELITREXOL/AG-2037. The company trades under the ticker PFE. Pfizer holds the asset, which is a small molecule GART inhibitor being investigated in oncology, specifically for colorectal neoplasms.

What phase is PELITREXOL/AG-2037 in?

PELITREXOL/AG-2037 is in Phase 2 development. Its single recorded trial, NCT00078468, was a Phase 2 study in metastatic colorectal cancer that has completed. The drug is investigational and has not received FDA approval for any indication.

What clinical trials is PELITREXOL/AG-2037 in?

PELITREXOL/AG-2037 has been evaluated in one clinical trial, NCT00078468, titled a study of the GARFT inhibitor AG2037 in patients with metastatic colorectal cancer who failed treatment. The Phase 2 trial enrolled 56 patients in the United States and is completed. It was an uncontrolled study without randomization or blinding.