Study of Talabostat + Docetaxel Versus Docetaxel in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

June 7, 2007 updated by: Point Therapeutics
This Phase 3 study will compare the efficacy of talabostat plus docetaxel to docetaxel plus placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy regimen.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 3

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
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Marshall Schreeder, MD
      • Muscle Shoals, Alabama, United States, 35661
        • James P. Daugherty, MD
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Cancer Research
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Hematology Oncology Associates
    • California
      • Anaheim, California, United States, 92801
        • Veena Charu, MD
      • Fountain Valley, California, United States, 92708
        • Lalita Pandit, MD, Inc
      • Fountain Valley, California, United States, 92708
        • Robert A. Moss, MD, FACP, Inc.
      • Oceanside, California, United States, 92056
        • Warren Paroly, MD
      • Pomona, California, United States, 91767
        • Swarna S. Chanduri, MD
      • Poway, California, United States, 92064-2527
        • Southwest Cancer Care Medical Group
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers
      • Denver, Colorado, United States, 80210
        • Mile High Oncology
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Medical Specialists of Fairfield
    • Florida
      • Brooksville, Florida, United States, 34613
        • Pasco Hernando Oncology Associates PA
      • Gainesville, Florida, United States, 32605
        • Lucio Gordan, MD
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research, LLC
      • Inverness, Florida, United States, 34452
        • Citrus Hematology and Oncology Center
      • Kissimmee, Florida, United States, 34741
        • Jorge G. Otoya, MD
      • Lecanto, Florida, United States, 34461
        • Cancer and Blood Disease Center
      • New Port Richey, Florida, United States, 34652
        • Pasco Hernando Oncology Associates, PA
      • Ocala, Florida, United States, 34474
        • Ocala Oncology Center
      • Ocoee, Florida, United States, 34761
        • Cancer Center of Florida
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60611
        • Hematology Oncology Associates of Illinois
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology Hematology Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Hematology Oncology Consultants
      • South Bend, Indiana, United States, 46617
        • Northern Indiana Oncology Associates
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Kansas City Cancer Centers, Southwest
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • Kentucky Cancer Clinic
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Medical Oncology, LLC
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Maryland Oncology Hematology, PA
      • Glen Burnie, Maryland, United States, 21061
        • Chesapeake Oncology Hematology Associates (Tate Center)
    • Michigan
      • Brownstown, Michigan, United States, 48183
        • Josephine Ford Cancer Center -- Downriver
      • Clinton Township, Michigan, United States, 48038
        • Michael McKenzie, DO
      • Dearborn, Michigan, United States, 48126
        • Henry Ford Medical Center -- Fairlane
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Port Huron, Michigan, United States, 48060
        • Youssef Hanna, MD
      • Rochester Hills, Michigan, United States, 48307
        • Cancer and Transplant Consultants, PLC
      • Rochester Hills, Michigan, United States, 48307
        • Cancer Care Associates
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
      • Royal Oak, Michigan, United States, 48073
        • Cancer Care Associates, PC
      • Royal Oak, Michigan, United States, 48073
        • Hematology Oncology Consultants
      • Royal Oak, Michigan, United States, 48073
        • Jeffrey H. Margolis, MD
      • Southgate, Michigan, United States, 48195
        • Michigan Hematology and Oncology Institute
      • St. Joseph, Michigan, United States, 49085
        • Oncology Care Associates, PLLC
      • Troy, Michigan, United States, 48085
        • Mitchell Folbe, Md, Pc
      • Troy, Michigan, United States, 48085
        • William Beaumont Hospital
      • West Bloomfield, Michigan, United States, 48322
        • Henry Ford Medical Center
    • Missouri
      • St. Joseph, Missouri, United States, 64507
        • St. Joseph Oncology, Inc.
      • St. Louis, Missouri, United States, 63141
        • Arch Medical Services, INC.
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • The Center for Cancer and Hematologic Disease
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology, PC
      • Glen Head, New York, United States, 11545
        • George A. Zervos, MD
    • North Carolina
      • Hickory, North Carolina, United States, 28602
        • Northwestern Carolina Oncology Hematology
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Cincinnati, Ohio, United States, 45242
        • Oncology/Hematology Care, Inc.
      • Dover, Ohio, United States, 44622
        • Gabrail Cancer Center
      • Kettering, Ohio, United States, 45409
        • Dayton Hematology and Oncology
      • Medina, Ohio, United States, 44256
        • Mukesh C. Bhatt, MD
      • Wooster, Ohio, United States, 44691
        • Trilogy Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Cancer Care Associates
      • Tulsa, Oklahoma, United States, 74136
        • Cancer Care Associates
    • Oregon
      • Portland, Oregon, United States, 97210
        • Northwest Cancer Specialists, Northrup
    • Pennsylvania
      • Gettysburg, Pennsylvania, United States, 17325
        • Shatish A. Shah, MD
      • Kingston, Pennsylvania, United States, 18704
        • Medical Oncology Associates of Wyoming Valley, PC
      • Philadelphia, Pennsylvania, United States, 19146
        • Rittenhouse Hematology Oncology Associates
      • West Chester, Pennsylvania, United States, 19380
        • Chester County Hematology / Oncology Services
    • South Carolina
      • Aiken, South Carolina, United States, 29801
        • Cancer Care Institute of Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Hematology Oncology, PA
      • Spartanburg, South Carolina, United States, 29303-3041
        • Palmetto Hematology Oncology, PC
    • Texas
      • Arlington, Texas, United States, 76014
        • Texas Cancer Center
      • Austin, Texas, United States, 78731
        • Texas Oncology Cancer Center
      • Dallas, Texas, United States, 75246
        • Mary Crowley Medical Research Center
      • Dallas, Texas, United States, 75237
        • Texas Cancer Center (Dallas Southwest)
      • Denton, Texas, United States, 76210
        • Texas Cancer Center / Denton
      • El Paso, Texas, United States, 79915
        • El Paso Cancer Treatment Center
      • Ft. Worth, Texas, United States, 76104
        • Texas Oncology, PA
      • Ft. Worth, Texas, United States, 76177
        • US Oncology Research and Clinical Pharmacy
      • Mesquite, Texas, United States, 75150
        • Texas Cancer Center of Mesquite
      • Midland, Texas, United States, 79701-5946
        • Allison Cancer Center
      • Odessa, Texas, United States, 79761
        • West Texas Cancer Center
      • Paris, Texas, United States, 75460-5004
        • Paris Regional Cancer Center
      • Sugar Land, Texas, United States, 77479
        • Texas Oncology Cancer Center--Sugar Land
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Annandale-Fairfax Virginia Hematology Oncology, PC
      • Gloucester, Virginia, United States, 23061
        • Peninsula Cancer Institute
      • Newport News, Virginia, United States, 23601
        • Peninsula Cancer Institute
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Salem, Virginia, United States, 24153
        • Oncology & Hematology Associates Of Southwest Virginia, Inc.
      • Williamsburg, Virginia, United States, 23185
        • Peninsula Cancer Institute
      • Woodbridge, Virginia, United States, 22191
        • Masoom Kandahari, MD, PC
    • Washington
      • Seattle, Washington, United States, 98133
        • Puget Sound Cancer Centers
      • Spokane, Washington, United States, 99204
        • Jay L. Wittenkeller, MD
      • Spokane, Washington, United States, 99218
        • Cancer Care Northwest Research
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists, PC

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:

  • Men or women age 18 years or older

  • Histologically or cytologically confirmed NSCLC

    • Recurrent, locally advanced or metastatic, inoperable NSCLC (Stage IIIB/IV)
    • Patients with Stage IIIB NSCLC must have a cytologically documented pleural effusion
  • Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC
  • Measurable disease on computerized tomography (CT) scan
  • ECOG Performance Status of 0 or 1
  • Expected survival ≥12 weeks
  • Provide written informed consent

EXCLUSION CRITERIA:

  • More than 2 prior chemotherapy regimens

  • 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
    • Serum creatinine ≥2.0mg/dL
    • Absolute neutrophil count <1500/μL or platelets <100,000/μL
  • Untreated or symptomatic brain metastases
  • 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
  • A history of severe hypersensitivity to drugs formulated with polysorbate 80
  • 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 28 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for NSCLC.
  • Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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 Major Dates

Study Start

January 1, 2006

Study Registration Dates

First Submitted

October 19, 2005

First Submitted That Met QC Criteria

October 19, 2005

First Posted (Estimate)

October 21, 2005

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTH-304

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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