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

NCT00090701

Last updated date
Study Location
Pfizer Investigational Site
Poway, California, 92064, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Lung Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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)

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 2, Open-Label, Multicenter Study of the GARFT Inhibitor in Patients With Metastatic Non-Small Cell Lung Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Neoplasms
Intervention  ICMJE Drug: AG2037
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 9, 2012)
0
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
56
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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 &#215; 109/L, and platelet count of >=100 &#215; 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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00090701
Other Study ID Numbers  ICMJE A4371005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP