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

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Poway, California, 92064 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 therapy, patients may have received only 1 additional regimen for metastatic disease

- No active brain metastases (requiring treatment or progressing)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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)

NCT00078468
Pfizer
Completed
Study of the GARFT Inhibitor AG2037 in Patients With Metastatic Colorectal Cancer Who Failed Treatment

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Study of the GARFT Inhibitor AG2037 in Patients With Metastatic Colorectal Cancer Who Failed Treatment
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.
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).
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colorectal Neoplasms
Drug: PELITREXOL/AG-2037
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
September 2004
Not Provided

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00078468
A4371004
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2006

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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