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Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer

This study has been completed.

Sponsored by: Point Therapeutics
Information provided by: Point Therapeutics
ClinicalTrials.gov Identifier: NCT00080080
  Purpose

The purpose of this study is to determine the antitumor activity (response rate, time to tumor progression, survival) and safety of docetaxel in combination with talabostat in patients with advanced non-small cell lung cancer (NSCLC) who have failed a prior platinum-containing regimen.


Condition Intervention Phase
Lung Cancer
Drug: talabostat (PT-100) tablets
Drug: Docetaxel
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer   

Drug Information available for:   Docetaxel    Talabostat mesylate    Talabostat   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Phase 2 Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed Stage IIIb/IV NSCLC
  • 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:

  • More than 2 prior chemotherapy regimens
  • 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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080080

Locations
United States, Florida
Cancer Center of Florida    
      Ocoee, Florida, United States, 34761
United States, Illinois
University of Chicago    
      Chicago, Illinois, United States, 60637
United States, Michigan
Van Elslander Cancer Center    
      Grosse Pointe Woods, Michigan, United States, 48236
United States, New York
New York Oncology/Hematology--Albany Regional Cancer Center    
      Albany, New York, United States, 12208
Mt. Sinai School of Medicine    
      New York, New York, United States, 10029
USB Cancer Center-- Nyack Hospital    
      Nyack, New York, United States, 10960
United States, Ohio
Dayton Oncology & Hematology    
      Kettering, Ohio, United States, 45409
United States, Texas
Mary Crowley Medical Research Center    
      Dallas, Texas, United States, 75246
Tyler Cancer Center    
      Tyler, Texas, United States, 75702
United States, Washington
Cancer Care Northwest    
      Spokane, Washington, United States, 99218

Sponsors and Collaborators
Point Therapeutics
  More Information


Study ID Numbers:   PTH-302
First Received:   March 23, 2004
Last Updated:   June 7, 2007
ClinicalTrials.gov Identifier:   NCT00080080
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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