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

Lung Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00090701
• Other study ID #: A4371005
• Status: Withdrawn
• Phase: Phase 2
• First received: September 2, 2004
• Last updated: May 9, 2012
• Start date: September 2004

Study information

• Verified date: May 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• AG2037

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Poway	California
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate the safety of AG-2037.
Secondary	Estimate the time to progression (TTP).
Secondary	Evaluate 1-year overall survival of patients treated with AG-2037.
Secondary	Evaluate population PK and correlate the various genetic markers of MTAP, folate, and purine metabolism with clinical response.

External Links

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