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

This study has been terminated.
(FDA Hold May 2007)
Sponsor:
Information provided by:
Point Therapeutics
ClinicalTrials.gov Identifier:
NCT00290017
First received: February 9, 2006
Last updated: June 7, 2007
Last verified: June 2007
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Lung Cancer
Neoplasms, Lung
Neoplasms, Pulmonary
Drug: talabostat
Drug: pemetrexed
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Point Therapeutics:

Estimated Enrollment: 400
Study Start Date: February 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290017

  Hide Study Locations
Locations
United States, Alabama
Marshall Schreeder, MD
Huntsville, Alabama, United States, 35801
United States, Arizona
Hematology Oncology Associates
Phoenix, Arizona, United States, 85012
United States, Arkansas
Heritage Physician Group—Oncology
Hot Springs, Arkansas, United States, 71913
United States, California
Raul R. Mena, MD
Burbank, California, United States, 91505-4866
Pacific Coast Hematology / Oncology Medical Group, Inc.
Fountain Valley, California, United States, 92708
Robert A. Moss, MD, FACP, Inc.
Fountain Valley, California, United States, 92708
Antelope Valley Cancer Center
Lancaster, California, United States, 93534
Warren Paroly, MD
Oceanside, California, United States, 92056
Southwest Cancer Care Medical Group
Poway, California, United States, 92064
United States, Colorado
Mile High Oncology
Denver, Colorado, United States, 80210
United States, Connecticut
Medical Specialists of Fairfield
Fairfield, Connecticut, United States, 06824
Northwestern Connecticut Oncology Hematology Associates, LLP
Torrington, Connecticut, United States, 06790
United States, Florida
Lucio Gordan, MD
Gainesville, Florida, United States, 32605
Cancer and Blood Disease Center
Lecanto, Florida, United States, 34461
Ocala Oncology Center
Ocala, Florida, United States, 34474
Cancer Center of Florida
Ocoee, Florida, United States, 34761
United States, Georgia
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States, 30607
United States, Idaho
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
Hematology Oncology Associates of Illinois
Chicago, Illinois, United States, 60611
Joliet Oncology-Hematology Associates
Joliet, Illinois, United States, 60435
United States, Indiana
American Health Network of Indiana--Hematology/Oncology
Indianapolis, Indiana, United States, 46202
Arnett Cancer Center
Lafayette, Indiana, United States, 08822
Northern Indiana Oncology Associates
South Bend, Indiana, United States, 46617
Associated Physicians and Surgeons, LLC
Terre Haute, Indiana, United States, 47804-4080
HUX Cancer Center/Union Hospital
Terre Haute, Indiana, United States, 47804-4080
United States, Kansas
Kansas City Cancer Center, LLC
Overland Park, Kansas, United States, 66210
United States, Kentucky
Kentucky Cancer Clinic
Hazard, Kentucky, United States, 41701
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Chesapeake Oncology Hematology Associates (Tate Center)
Glen Burnie, Maryland, United States, 21061
Carroll County Cancer Center
Westminster, Maryland, United States, 21157
United States, Massachusetts
Fallon Clinic, Inc. at Worcester Medical Center
Worcester, Massachusetts, United States, 01608
United States, Michigan
Michael McKenzie, DO
Clinton Township, Michigan, United States, 48038
Youssef Hanna, MD
Port Huron, Michigan, United States, 48060
Cancer and Transplant Consultants, PLC
Rochester Hills, Michigan, United States, 48307
Cancer Care Associates
Rochester Hills, Michigan, United States, 48307
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Cancer Care Associates, PC
Royal Oak, Michigan, United States, 48073
Jeffrey H. Margolis, MD
Royal Oak, Michigan, United States, 48073
Hematology Oncology Consultants
Royal Oak, Michigan, United States, 48073
Dr. Folbe, MD/PC
Troy, Michigan, United States, 48085
William Beaumont Hospital
Troy, Michigan, United States, 48085
United States, Minnesota
Minnesota Oncology Hematology, PA
Burnsville, Minnesota, United States, 55337
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, United States, 55404
United States, Missouri
St. Joseph Oncology, Inc.
St. Joseph, Missouri, United States, 64507
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89109
VA Sierra Nevada Health Care System
Reno, Nevada, United States, 89502
United States, New Jersey
Hunterdon Regional Cancer Center
Flemington, New Jersey, United States, 08822
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
Hematology Oncology Associates, SJ, PA
Mount Holly, New Jersey, United States, 08060
Mercer Bucks Oncology/Hematology
Trenton, New Jersey, United States, 08618
Capital Health System
Trenton, New Jersey, United States, 08618
United States, New York
New York Oncology Hematology, PC
Albany, New York, United States, 12208
United States, North Carolina
Northwestern Carolina Oncology & Hematology, PA
Hickory, North Carolina, United States, 28602
Eugene Paschold, MD
Winston Salem, North Carolina, United States, 27013
Piedmont Hematology Oncology / Winston-Salem
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Oncology/Hematology Care, Inc.
Cincinnati, Ohio, United States, 45242
Dayton Oncology & Hematology, PA
Kettering, Ohio, United States, 45409
United States, Oklahoma
Cancer Care Associates
Oklahoma City, Oklahoma, United States, 73120
Cancer Care Associates
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Satish A. Shah, MD
Gettysburg, Pennsylvania, United States, 17325
Medical Oncology Associates of Wyoming Valley, PC
Kingston, Pennsylvania, United States, 18704
St. Mary Medical Center--Research Center
Langhorne, Pennsylvania, United States, 19047
Hematology-Oncology Group, PC
Langhorne, Pennsylvania, United States, 19047
Paoli Hospital
Paoli, Pennsylvania, United States, 19301
Rittenhouse Hematology Oncology Associates
Philadelphia, Pennsylvania, United States, 19146
Pottstown Memorial Medical Center
Pottstown, Pennsylvania, United States, 19464
Grandview Hospital
Sellersville, Pennsylvania, United States
Bux-Mont Oncology-Hematology
Sellersville, Pennsylvania, United States, 18960
United States, South Carolina
Cancer Care Institute of Carolina
Aiken, South Carolina, United States, 29801
Charleston Hematology Oncology, PA
Charleston, South Carolina, United States, 29403
Palmetto Hematology Oncology PC
Spartanburg, South Carolina, United States, 29303-3041
United States, Tennessee
Associates in Oncology and Hematology
Chattanooga, Tennessee, United States, 37404
McLeod Cancer and Blood Center
Johnson City, Tennessee, United States, 37604
University of Tennessee
Knoxville, Tennessee, United States, 37920
United States, Texas
Texas Cancer Center
Arlington, Texas, United States, 76014
Texas Oncology Cancer Center
Austin, Texas, United States, 78731
Texas Cancer Center (Dallas Southwest)
Dallas, Texas, United States, 75237
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246
Texas Cancer Center / Denton
Denton, Texas, United States, 76210
Texas Oncology, PA
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
US Oncology Research and Clinical Pharmacy
Ft. Worth, Texas, United States, 76177
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410
Texas Oncology, PA
Mesquite, Texas, United States, 75150
Texas Oncology, PA / Allison Cancer Center
Midland, Texas, United States, 79701-5946
West Texas Cancer Center
Odessa, Texas, United States, 79761
Paris Regional Cancer Center
Paris, Texas, United States, 75460-5004
Texas Oncology Cancer Center--Sugar Land
Sugar Land, Texas, United States, 77479
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Virginia
Cancer Outreach Associates, PC / Outreach Clinical Trial Consortium LLC
Abingdon, Virginia, United States, 24211
Fairfax Northern Virginia Hematology / Oncology, PC
Fairfax, Virginia, United States, 22031
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Virginia Physicians, Inc.
Richmond, Virginia, United States, 23229
Oncology & Hematology Associates of Southwest Virginia
Salem, Virginia, United States, 24153
United States, Washington
Luke Walker, MD
Everett, Washington, United States, 98206
Cascade Cancer Center
Kirkland, Washington, United States, 98034-3013
Puget Sound Cancer Centers
Seattle, Washington, United States, 98133
Cancer Care Northwest
Spokane, Washington, United States, 99218
Northwest Cancer Specialists, PC
Vancouver, Washington, United States, 98684
United States, Wisconsin
Medical Consultants, Ltd.
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Point Therapeutics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00290017     History of Changes
Other Study ID Numbers: PTH-305
Study First Received: February 9, 2006
Last Updated: June 7, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on April 17, 2014