A Phase 2, Open-Label, Multicenter Study of the GARFT Inhibitor in Patients With Metastatic Non-Small Cell Lung Cancer
NCT00090701
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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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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 | 0 | |||
Original Enrollment ICMJE | 56 | |||
Study Completion Date ICMJE | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |