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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00080080
Recruitment Status : Completed
First Posted : March 24, 2004
Last Update Posted : June 8, 2007
Sponsor:
Information provided by:
Point Therapeutics

Brief Summary:
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 or disease Intervention/treatment Phase
Lung Cancer Drug: talabostat (PT-100) tablets Drug: Docetaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080080


Locations
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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

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ClinicalTrials.gov Identifier: NCT00080080    
Other Study ID Numbers: PTH-302
First Posted: March 24, 2004    Key Record Dates
Last Update Posted: June 8, 2007
Last Verified: June 2007
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action