Lung NeoplasmsPhase 2NCT00090701
A Phase 2, Open-Label, Multicenter Study of the GARFT Inhibitor in Patients With Metastatic Non-Small Cell Lung Cancer
A Phase 2 study testing AG2037 in people with Lung Neoplasms, run by Pfizer at 4 sites in United States.
Trial summary
The primary objective of this study is to determine safety and activity of a novel anticancer agent in patients with metastatic non-small cell lung cancer who failed 2 or 3 prior systemic treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- AG2037
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2004to not given
- 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
- presence of measurable, metastatic non-small cell lung cancer (histologically or cytologically confirmed at the time of original diagnosis)
- treatment failure (recurrence, disease progression, or intolerable toxicity) of 2 or 3 prior systemic treatments. (Note: no more than 3 prior systemic regimens for non-small cell lung cancer including adjuvant chemotherapy)
- capable of understanding the nature of the trial and willing to give written informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
- hemoglobin level of >=9 g/dL, absolute granulocyte count of >=1.5 \× 109/L, and platelet count of >=100 \× 109/L
- adequate renal function, as documented by a serum creatinine level of <=1.5 times the institutional upper limit of normal (ULN) and a measured or calculated creatinine clearance of >=60 mL/min
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- adequate liver function, as demonstrated by a total bilirubin level of <=1.5 times ULN; levels of serum glutamate oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) <=2 times ULN. If the patient has liver involvement then AST and ALT should be <=5 times ULN
- for men with partners of child-bearing potential and all women of childbearing potential, willingness to use adequate contraception or practice abstinence during the course of the study at least 18 years of age
- life expectancy estimated at greater than 12 weeks
Who cannot join
- history of blood transfusion within the last 14 days
- need of concurrent administration of allopurinol
- history of radiotherapy or chemotherapy within 4 weeks (nitrosourea or mitomycin C within 6 weeks) of the anticipated first day of dosing (patient must be fully recovered from the acute effects of any prior chemotherapy or radiotherapy)
- any psychological or sociological condition, addictive disorder, or family problems that might preclude compliance with the protocol
- any unstable or severe intercurrent medical condition that in the opinion of the investigator might interfere with achievement of study objectives
- receipt of an investigational agent within 28 days before the anticipated first day of dosing (patient must have recovered from all acute effects of previously administered investigational agents)
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- pregnant or breast-feeding
- previous treatment with GARFT inhibitors
- history of radiation therapy to more than 40% of the marrow space
- history of a malignancy (other than non-small cell lung cancer) except 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 progressing)
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 Non Small Cell Lung Cancer Who Failed Two Or Three Prior Treatments
The primary objective of this study is to determine safety and activity of a novel anticancer agent in patients with metastatic non-small cell lung cancer who failed 2 or 3 prior systemic treatments.
- Conditions
- Lung Neoplasms
- Being tested
- AG2037
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG2037Drug
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 non-small cell lung cancer who failed 2 or 3 prior systematic treatments.
Secondary outcomes (4)
Evaluate the safety of AG-2037.
Estimate the time to progression (TTP).
Evaluate 1-year overall survival of patients treated with AG-2037.
Evaluate population PK and 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 posted6 Sep 2004 (estimated)
- Study startSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- 0 participants (actual)
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
- NCT00090701
- Sponsor's protocol ID
- A4371005
- Status last verified
- May 2012
- First submitted
- 2 Sep 2004
- Last updated
- 10 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. 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 Non Small Cell Lung Cancer Who Failed Two Or Three Prior Treatments
- ClinicalTrials.gov ID
- NCT00090701
- Acronym / sponsor ID
- A4371005
- Conditions
- Lung Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- First posted
- 6 Sep 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.
The primary objective of this study is to determine safety and activity of a novel anticancer agent in patients with metastatic non-small cell lung cancer who failed 2 or 3 prior systemic treatments.
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 (9 listed)
- presence of measurable, metastatic non-small cell lung cancer (histologically or cytologically confirmed at the time of original diagnosis)
- treatment failure (recurrence, disease progression, or intolerable toxicity) of 2 or 3 prior systemic treatments. (Note: no more than 3 prior systemic regimens for non-small cell lung cancer including adjuvant chemotherapy)
- capable of understanding the nature of the trial and willing to give written informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
- hemoglobin level of >=9 g/dL, absolute granulocyte count of >=1.5 \× 109/L, and platelet count of >=100 \× 109/L
Key exclusion criteria (11 listed)
- history of blood transfusion within the last 14 days
- need of concurrent administration of allopurinol
- history of radiotherapy or chemotherapy within 4 weeks (nitrosourea or mitomycin C within 6 weeks) of the anticipated first day of dosing (patient must be fully recovered from the acute effects of any prior chemotherapy or radiotherapy)
- any psychological or sociological condition, addictive disorder, or family problems that might preclude compliance with the protocol
- any unstable or severe intercurrent medical condition that in the opinion of the investigator 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 |
|---|---|---|
| AG2037 | Drug | – |
Primary outcome
To determine the overall objective response rate (complete and partial responses) of AG-2037 in patients with metastatic non-small cell lung cancer who failed 2 or 3 prior systematic treatments.
4 secondary outcomes
Evaluate the safety of AG-2037.
Estimate the time to progression (TTP).
Evaluate 1-year overall survival of patients treated with AG-2037.
Evaluate population PK and correlate the various genetic markers of MTAP, folate, and purine metabolism with clinical response.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2012.
- 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 AG2037 in people with Lung 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 9 inclusion and 11 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: withdrawn, as of the sponsor's last update on 10 May 2012. 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 was withdrawn before enrolling participants, so there are no results.
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 non-small cell lung cancer who failed 2 or 3 prior systematic treatments.. 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 10 May 2012.