Completed

A Phase 2 Open-Label Multicenter Study Of The Garft Inhibitor AG2037 In Patients With Metastatic Colorectal Cancer Who Failed Treatment With A 5-Fluorouracil/Leucovorin Regimen.

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What is being tested

Data Collection

Who is being recruted

Colonic Diseases+8

+ Digestive System Diseases

+ Digestive System Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2003
See protocol details

Summary

Principal SponsorPfizer
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2003

Actual date on which the first participant was enrolled.

To determine the response rate in patients with metastatic colorectal cancer who failed treatment with a 5-Fluorouracil/Leucovorin regimen and up to one other chemotherapeutic regimen (not including adjuvant chemotherapy).

Official TitleA Phase 2 Open-Label Multicenter Study Of The Garft Inhibitor AG2037 In Patients With Metastatic Colorectal Cancer Who Failed Treatment With A 5-Fluorouracil/Leucovorin Regimen. 
Principal SponsorPfizer
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

56 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal Neoplasms

Criteria

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 calcium (5-FU/LV) * Prior irinotecan or oxaliplatin as part of the 5-FU/LV regimen or as subsequent therapy allowed * Only 2 prior regimens for metastatic disease allowed * One additional regimen as adjuvant therapy allowed provided patient remained disease-free for \> 6 months after completion of therapy\* * Newer, targeted investigational agents (e.g., cetuximab or bevacizumab) are not counted as a chemotherapeutic regimen unless used in combination with a cytotoxic regimen NOTE: \*If evidence of failure occurred within \< 6 months after completion of adjuvant therapy, patients may have received only 1 additional regimen for metastatic disease * No active brain metastases (requiring treatment or progressing) Exclusion Criteria: * History of blood transfusion within 14 days * Need of concurrent Administration of allopurinol * History of Radiotherapy or Chemotherapy within 4 weeks * Any psychological or sociological condition, addidtive disorder or family problems that might preclude compliance with the protocol * Any unstable or severe intercurrent medical condition that in the opinion of th einvestigator might interfere with achievement of study objectives * Receipt of an investigational agent within 28 days prior to first day of dosing with AG-2037 * Pregnant or breast feeding * Previous treatment with GARFT inhibitors * History of a malignancy (other than colorectal cancer) excpet those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years * Active brain metastases (requiring treatment or progression)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Pfizer Investigational Site

Poway, United StatesSee the location
Suspended

Pfizer Investigational Site

Washington, United States
Suspended

Pfizer Investigational Site

Tampa, United States
Suspended

Pfizer Investigational Site

New York, United States
Completed4 Study Centers