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

June 7, 2007 updated by: Point Therapeutics

Phase 2 Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Point Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 23, 2004

First Submitted That Met QC Criteria

March 23, 2004

First Posted (Estimate)

March 24, 2004

Study Record Updates

Last Update Posted (Estimate)

June 8, 2007

Last Update Submitted That Met QC Criteria

June 7, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTH-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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