Study of Talabostat and Pemetrexed vs. Pemetrexed in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

June 7, 2007 updated by: Point Therapeutics

A Phase 3, Randomized, Double-Blind, Multicenter Study of Talabostat and Pemetrexed vs. Pemetrexed and Placebo in Patients With Advanced (Stage IIIB/IV) Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

This Phase 3 study will compare the efficacy of talabostat plus pemetrexed to pemetrexed 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
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Hematology Oncology Associates
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Heritage Physician Group-Oncology
    • California
      • Burbank, California, United States, 91505-4866
        • Raul R. Mena, MD
      • Fountain Valley, California, United States, 92708
        • Robert A. Moss, MD, FACP, Inc.
      • Fountain Valley, California, United States, 92708
        • Pacific Coast Hematology / Oncology Medical Group, Inc.
      • Lancaster, California, United States, 93534
        • Antelope Valley Cancer Center
      • Oceanside, California, United States, 92056
        • Warren Paroly, MD
      • Poway, California, United States, 92064
        • Southwest Cancer Care Medical Group
    • Colorado
      • Denver, Colorado, United States, 80210
        • Mile High Oncology
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Medical Specialists of Fairfield
      • Torrington, Connecticut, United States, 06790
        • Northwestern Connecticut Oncology Hematology Associates, LLP
    • Florida
      • Gainesville, Florida, United States, 32605
        • Lucio Gordan, MD
      • Lecanto, Florida, United States, 34461
        • Cancer and Blood Disease Center
      • Ocala, Florida, United States, 34474
        • Ocala Oncology Center
      • Ocoee, Florida, United States, 34761
        • Cancer Center of Florida
    • Georgia
      • Athens, Georgia, United States, 30607
        • Northeast Georgia Cancer Care, LLC
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • North Idaho Cancer Center
    • Illinois
      • 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
        • American Health Network of Indiana--Hematology/Oncology
      • Lafayette, Indiana, United States, 08822
        • Arnett Cancer Center
      • South Bend, Indiana, United States, 46617
        • Northern Indiana Oncology Associates
      • Terre Haute, Indiana, United States, 47804-4080
        • Associated Physicians and Surgeons, LLC
      • Terre Haute, Indiana, United States, 47804-4080
        • HUX Cancer Center/Union Hospital
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Kansas City Cancer Center, LLC
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • Kentucky Cancer Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
      • Glen Burnie, Maryland, United States, 21061
        • Chesapeake Oncology Hematology Associates (Tate Center)
      • Westminster, Maryland, United States, 21157
        • Carroll County Cancer Center
    • Massachusetts
      • Worcester, Massachusetts, United States, 01608
        • Fallon Clinic, Inc. at Worcester Medical Center
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Michael McKenzie, DO
      • 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
      • Troy, Michigan, United States, 48085
        • William Beaumont Hospital
      • Troy, Michigan, United States, 48085
        • Dr. Folbe, MD/PC
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Minnesota Oncology Hematology, PA
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Oncology Hematology, PA
    • Missouri
      • St. Joseph, Missouri, United States, 64507
        • St. Joseph Oncology, Inc.
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Comprehensive Cancer Centers of Nevada
      • Reno, Nevada, United States, 89502
        • VA Sierra Nevada Health Care System
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • Hunterdon Regional Cancer Center
      • Long Branch, New Jersey, United States, 07740
        • Monmouth Medical Center
      • Mount Holly, New Jersey, United States, 08060
        • Hematology Oncology Associates, SJ, PA
      • Trenton, New Jersey, United States, 08618
        • Capital Health System
      • Trenton, New Jersey, United States, 08618
        • Mercer Bucks Oncology/Hematology
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology, PC
    • North Carolina
      • Hickory, North Carolina, United States, 28602
        • Northwestern Carolina Oncology & Hematology, PA
      • Winston Salem, North Carolina, United States, 27013
        • Eugene Paschold, MD
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Hematology Oncology / Winston-Salem
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology/Hematology Care, Inc.
      • Kettering, Ohio, United States, 45409
        • Dayton Oncology & Hematology, PA
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Cancer Care Associates
      • Tulsa, Oklahoma, United States, 74136
        • Cancer Care Associates
    • Pennsylvania
      • Gettysburg, Pennsylvania, United States, 17325
        • Satish A. Shah, MD
      • Kingston, Pennsylvania, United States, 18704
        • Medical Oncology Associates of Wyoming Valley, PC
      • Langhorne, Pennsylvania, United States, 19047
        • Hematology-Oncology Group, PC
      • Langhorne, Pennsylvania, United States, 19047
        • St. Mary Medical Center--Research Center
      • Paoli, Pennsylvania, United States, 19301
        • Paoli Hospital
      • Philadelphia, Pennsylvania, United States, 19146
        • Rittenhouse Hematology Oncology Associates
      • Pottstown, Pennsylvania, United States, 19464
        • Pottstown Memorial Medical Center
      • Sellersville, Pennsylvania, United States, 18960
        • Bux-Mont Oncology-Hematology
      • Sellersville, Pennsylvania, United States
        • Grandview Hospital
    • 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
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Associates in Oncology and Hematology
      • Johnson City, Tennessee, United States, 37604
        • McLeod Cancer and Blood Center
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee
    • 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--East
      • El Paso, Texas, United States, 79915
        • Texas Oncology, PA
      • Ft. Worth, Texas, United States, 76104
        • Texas Oncology, PA
      • Ft. Worth, Texas, United States, 76177
        • US Oncology Research and Clinical Pharmacy
      • Lubbock, Texas, United States, 79410
        • Joe Arrington Cancer Research and Treatment Center
      • Mesquite, Texas, United States, 75150
        • Texas Oncology, PA
      • Midland, Texas, United States, 79701-5946
        • Texas Oncology, PA / 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
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center
    • Virginia
      • Abingdon, Virginia, United States, 24211
        • Cancer Outreach Associates, PC / Outreach Clinical Trial Consortium LLC
      • Fairfax, Virginia, United States, 22031
        • Fairfax Northern Virginia Hematology / Oncology, PC
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Richmond, Virginia, United States, 23229
        • Virginia Physicians, Inc.
      • Salem, Virginia, United States, 24153
        • Oncology & Hematology Associates of Southwest Virginia
    • Washington
      • Everett, Washington, United States, 98206
        • Luke Walker, MD
      • Kirkland, Washington, United States, 98034-3013
        • Cascade Cancer Center
      • Seattle, Washington, United States, 98133
        • Puget Sound Cancer Centers
      • Spokane, Washington, United States, 99218
        • Cancer Care Northwest
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists, PC
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Medical Consultants, Ltd.

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
  • 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
  • Progression of disease on prior pemetrexed treatment
  • Brain metastases (exception: patients who 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)
  • Serum creatinine ≥2.0mg/dL or creatinine clearance <45mL/min
  • Absolute neutrophil count <1500/μL or platelets <100,000/μL
  • Any malignancy within 5 years immediately prior to the first dose of study medication (exception: basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix)
  • 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 investigational medication for NSCLC. Patients must have recovered from all of the side effects of treatment.
  • Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception during treatment.

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: Single Group 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

February 1, 2006

Study Registration Dates

First Submitted

February 9, 2006

First Submitted That Met QC Criteria

February 9, 2006

First Posted (Estimate)

February 10, 2006

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-305

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.

Subscribe