Colorectal NeoplasmsPhase 2NCT00078468
Study of the GARFT Inhibitor AG2037 in Patients With Metastatic Colorectal Cancer Who Failed Treatment
A Phase 2 study testing PELITREXOL/AG-2037 in people with Colorectal Neoplasms, run by Pfizer at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- PELITREXOL/AG-2037
- How many people
- 56 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2003to Sep 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
Poway, California, 92064
Pfizer Investigational Site
Tampa, Florida, 33612
Pfizer Investigational Site
Washington D.C., District of Columbia, 20007
About this study
Official title: 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).
- Conditions
- Colorectal Neoplasms
- Being tested
- PELITREXOL/AG-2037
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PELITREXOL/AG-2037Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Secondary outcomes (6)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2004 (estimated)
- Study startDec 2003
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078468
- Sponsor's protocol ID
- A4371004
- Status last verified
- Aug 2006
- First submitted
- 27 Feb 2004
- Last updated
- 9 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00078468
- Acronym / sponsor ID
- A4371004
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Study completion
- Sep 2004
- First posted
- 2 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PELITREXOL/AG-2037 | Drug | – |
Primary outcome
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.
6 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2006.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PELITREXOL/AG-2037 in people with Colorectal Neoplasms, run by Pfizer at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2006.