Completed

Study of the GARFT Inhibitor AG2037 in Patients With Metastatic Colorectal Cancer Who Failed Treatment

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What is being tested

PELITREXOL/AG-2037

Drug
Who is being recruted

Colorectal Neoplasms

Over 18 Years
+20 Eligibility Criteria

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: November 9, 2006
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2003Actual 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: November 9, 2006
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Colorectal Neoplasms
Criteria
10 inclusion criteria required to participate
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)

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10 exclusion criteria prevent from participating
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

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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 SitePoway, United StatesSee the location
Suspended
Pfizer Investigational SiteWashington, United States
Suspended
Pfizer Investigational SiteTampa, United States
Suspended
Pfizer Investigational SiteNew York, United States
Completed4 Study Centers