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Trial record 1 of 1 for:    NCT00078468
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Study of the GARFT Inhibitor AG2037 in Patients With Metastatic Colorectal Cancer Who Failed Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00078468
Recruitment Status : Completed
First Posted : March 2, 2004
Last Update Posted : November 9, 2006
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE February 27, 2004
First Posted Date  ICMJE March 2, 2004
Last Update Posted Date November 9, 2006
Study Start Date  ICMJE December 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2006)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2006)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the GARFT Inhibitor AG2037 in Patients With Metastatic Colorectal Cancer Who Failed Treatment
Official Title  ICMJE 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.
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Neoplasms
Intervention  ICMJE Drug: PELITREXOL/AG-2037
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
56
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00078468
Other Study ID Numbers  ICMJE A4371004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2006

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