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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: February 27, 2004
Last updated: November 8, 2006
Last verified: August 2006

February 27, 2004
November 8, 2006
December 2003
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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.
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Complete list of historical versions of study NCT00078468 on Archive Site
  • 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.
  • To evaluate the safety of AG-2037.
  • To evalutate the PK and PD of AG-2037.
  • To correlate the various genetic markers of MTAP, folate and purine metabolism with clinical response.
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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).
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Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Neoplasms
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2004
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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)
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
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Study Director: Pfizer Call Center Pfizer
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP