A Phase 2, Open-Label, Multicenter Study of the GARFT Inhibitor in Patients With Metastatic Non-Small Cell Lung Cancer

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Lung Neoplasms	Drug: AG2037	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	September 2004

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. Evaluate the safety of AG-2037.
2. Estimate the time to progression (TTP).
3. Evaluate 1-year overall survival of patients treated with AG-2037.
4. Evaluate population PK and correlate the various genetic markers of MTAP, folate, and purine metabolism with clinical response.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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)
• 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)

Contacts and Locations

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Locations

United States, California
Pfizer Investigational Site
Poway, California, United States, 92064
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20007
United States, Florida
Pfizer Investigational Site
Tampa, Florida, United States, 33612
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Additional Information:

To obtain contact information for a study center near you, click here. 

ClinicalTrials.gov Identifier:	NCT00090701 History of Changes
Other Study ID Numbers:	A4371005
First Posted:	September 6, 2004
Last Update Posted:	May 10, 2012
Last Verified:	May 2012

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms	Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases