You are here

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

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Poway, California, 92064 United States
Contact
1-800-718-1021
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 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 ULN; levels of serum glutamate oxaloacetic transaminase (SGOT) (aspartate
aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine
aminotransferase [ALT]) and ALT should be

- 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)

NCT00090701
Pfizer
Withdrawn
A Phase 2, Open-Label, Multicenter Study of the GARFT Inhibitor in Patients With Metastatic Non-Small Cell Lung Cancer

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Small Cell Lung Cancer (SCLC), Follicular Lymphoma (FL), Castration Resistant Prostate Cancer (CRPC), Diffuse Large B-Cell Lymphoma (DLBCL)
NCT03460977
All Genders
18+
Years
Multiple Sites
Non-Small Cell Lung Cancer, Urothelial Cancer
NCT03472560
All Genders
18+
Years
Multiple Sites
Non-Small Cell Lung Cancer
NCT02349633
All Genders
18+
Years
Multiple Sites
A Phase 2, Open-Label, Multicenter Study of the GARFT Inhibitor in Patients With Metastatic Non-Small Cell Lung Cancer
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lung Neoplasms
Drug: AG2037
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00090701
A4371005
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now