NCT00090701

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

4 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 6, 2004

Completed
Last Updated

May 10, 2012

Status Verified

May 1, 2012

First QC Date

September 2, 2004

Last Update Submit

May 9, 2012

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (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 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.

Interventions

AG2037DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pfizer Investigational Site

Poway, California, 92064, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20007, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33612, United States

Location

Pfizer Investigational Site

New York, New York, 10021, United States

Location

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 2, 2004

First Posted

September 6, 2004

Study Start

September 1, 2004

Last Updated

May 10, 2012

Record last verified: 2012-05

Locations

US(4)