Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer
NCT ID: NCT00080080
Last Updated: 2007-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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talabostat (PT-100) tablets
Docetaxel
Eligibility Criteria
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Inclusion Criteria
* Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC
* Measurable disease
* ECOG Performance Status of 0 or 1
* Expected survival ≥12 weeks
* Provide written informed consent
Exclusion Criteria
* Brain metastases (exception: patients who have had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least 1 month)
* Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
* The need for chronic (i.e., \>7 days) oral or intravenous corticosteroid therapy
* A history of severe hypersensitivity reactions to drugs formulated with polysorbate 80
* A history of myocardial infarction within 1 year of study entry, CABG within 6 months of study entry, severe congestive heart failure (ejection fraction \<30%), history of ventricular arrhythmia, or other uncontrolled cardiac arrhythmia
* Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
* Patients who are within 30 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for NSCLC. Patients must have recovered from all of the side effects of treatment in order to be enrolled.
* Pregnant or lactating women.
* Clinically significant laboratory abnormalities, specifically:
Total bilirubin ≥institutional upper limit of normal (ULN); Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x ULN concomitant with alkaline phosphatase \>2.5 x ULN; Hepatitis B surface antigen or antibody to Hepatitis C (anti-HCV antibody); Serum creatinine ≥2.0mg/dL; or Granulocytes \<1500/μL or platelets \<100,000/μL.
18 Years
ALL
No
Sponsors
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Point Therapeutics
INDUSTRY
Locations
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Cancer Center of Florida
Ocoee, Florida, United States
University of Chicago
Chicago, Illinois, United States
Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, United States
New York Oncology/Hematology--Albany Regional Cancer Center
Albany, New York, United States
Mt. Sinai School of Medicine
New York, New York, United States
USB Cancer Center-- Nyack Hospital
Nyack, New York, United States
Dayton Oncology & Hematology
Kettering, Ohio, United States
Mary Crowley Medical Research Center
Dallas, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Cancer Care Northwest
Spokane, Washington, United States
Countries
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Other Identifiers
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PTH-302
Identifier Type: -
Identifier Source: org_study_id