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

NCT00290017 | Terminated Phase 3

• 1 other identifier: PTH-305
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 101

Brief Summary

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.

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Cancer; Neoplasms, Lung; Neoplasms, Pulmonary

Interventions

talabostat DRUG

pemetrexed DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Point Therapeutics: lead

Study Sites (101)

Marshall Schreeder, MD

Huntsville, Alabama, 35801, United States

Location

Hematology Oncology Associates

Phoenix, Arizona, 85012, United States

Location

Heritage Physician Group-Oncology

Hot Springs, Arkansas, 71913, United States

Location

Raul R. Mena, MD

Burbank, California, 91505-4866, United States

Location

Pacific Coast Hematology / Oncology Medical Group, Inc.

Fountain Valley, California, 92708, United States

Location

Robert A. Moss, MD, FACP, Inc.

Fountain Valley, California, 92708, United States

Location

Antelope Valley Cancer Center

Lancaster, California, 93534, United States

Location

Warren Paroly, MD

Oceanside, California, 92056, United States

Location

Southwest Cancer Care Medical Group

Poway, California, 92064, United States

Location

Mile High Oncology

Denver, Colorado, 80210, United States

Location

Medical Specialists of Fairfield

Fairfield, Connecticut, 06824, United States

Location

Northwestern Connecticut Oncology Hematology Associates, LLP

Torrington, Connecticut, 06790, United States

Location

Lucio Gordan, MD

Gainesville, Florida, 32605, United States

Location

Cancer and Blood Disease Center

Lecanto, Florida, 34461, United States

Location

Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

Cancer Center of Florida

Ocoee, Florida, 34761, United States

Location

Northeast Georgia Cancer Care, LLC

Athens, Georgia, 30607, United States

Location

North Idaho Cancer Center

Coeur d'Alene, Idaho, 83814, United States

Location

Hematology Oncology Associates of Illinois

Chicago, Illinois, 60611, United States

Location

Joliet Oncology-Hematology Associates

Joliet, Illinois, 60435, United States

Location

American Health Network of Indiana--Hematology/Oncology

Indianapolis, Indiana, 46202, United States

Location

Arnett Cancer Center

Lafayette, Indiana, 08822, United States

Location

Northern Indiana Oncology Associates

South Bend, Indiana, 46617, United States

Location

Associated Physicians and Surgeons, LLC

Terre Haute, Indiana, 47804-4080, United States

Location

HUX Cancer Center/Union Hospital

Terre Haute, Indiana, 47804-4080, United States

Location

Kansas City Cancer Center, LLC

Overland Park, Kansas, 66210, United States

Location

Kentucky Cancer Clinic

Hazard, Kentucky, 41701, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Chesapeake Oncology Hematology Associates (Tate Center)

Glen Burnie, Maryland, 21061, United States

Location

Carroll County Cancer Center

Westminster, Maryland, 21157, United States

Location

Fallon Clinic, Inc. at Worcester Medical Center

Worcester, Massachusetts, 01608, United States

Location

Michael McKenzie, DO

Clinton Township, Michigan, 48038, United States

Location

Youssef Hanna, MD

Port Huron, Michigan, 48060, United States

Location

Cancer and Transplant Consultants, PLC

Rochester Hills, Michigan, 48307, United States

Location

Cancer Care Associates

Rochester Hills, Michigan, 48307, United States

Location

Cancer Care Associates, PC

Royal Oak, Michigan, 48073, United States

Location

Hematology Oncology Consultants

Royal Oak, Michigan, 48073, United States

Location

Jeffrey H. Margolis, MD

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Dr. Folbe, MD/PC

Troy, Michigan, 48085, United States

Location

William Beaumont Hospital

Troy, Michigan, 48085, United States

Location

Minnesota Oncology Hematology, PA

Burnsville, Minnesota, 55337, United States

Location

Minnesota Oncology Hematology, PA

Minneapolis, Minnesota, 55404, United States

Location

St. Joseph Oncology, Inc.

Saint Joseph, Missouri, 64507, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89109, United States

Location

VA Sierra Nevada Health Care System

Reno, Nevada, 89502, United States

Location

Hunterdon Regional Cancer Center

Flemington, New Jersey, 08822, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

Location

Hematology Oncology Associates, SJ, PA

Mount Holly, New Jersey, 08060, United States

Location

Capital Health System

Trenton, New Jersey, 08618, United States

Location

Mercer Bucks Oncology/Hematology

Trenton, New Jersey, 08618, United States

Location

New York Oncology Hematology, PC

Albany, New York, 12208, United States

Location

Northwestern Carolina Oncology & Hematology, PA

Hickory, North Carolina, 28602, United States

Location

Eugene Paschold, MD

Winston-Salem, North Carolina, 27013, United States

Location

Piedmont Hematology Oncology / Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Oncology/Hematology Care, Inc.

Cincinnati, Ohio, 45242, United States

Location

Dayton Oncology & Hematology, PA

Kettering, Ohio, 45409, United States

Location

Cancer Care Associates

Oklahoma City, Oklahoma, 73120, United States

Location

Cancer Care Associates

Tulsa, Oklahoma, 74136, United States

Location

Satish A. Shah, MD

Gettysburg, Pennsylvania, 17325, United States

Location

Medical Oncology Associates of Wyoming Valley, PC

Kingston, Pennsylvania, 18704, United States

Location

Hematology-Oncology Group, PC

Langhorne, Pennsylvania, 19047, United States

Location

St. Mary Medical Center--Research Center

Langhorne, Pennsylvania, 19047, United States

Location

Paoli Hospital

Paoli, Pennsylvania, 19301, United States

Location

Rittenhouse Hematology Oncology Associates

Philadelphia, Pennsylvania, 19146, United States

Location

Pottstown Memorial Medical Center

Pottstown, Pennsylvania, 19464, United States

Location

Bux-Mont Oncology-Hematology

Sellersville, Pennsylvania, 18960, United States

Location

Grandview Hospital

Sellersville, Pennsylvania, United States

Location

Cancer Care Institute of Carolina

Aiken, South Carolina, 29801, United States

Location

Charleston Hematology Oncology, PA

Charleston, South Carolina, 29403, United States

Location

Palmetto Hematology Oncology PC

Spartanburg, South Carolina, 29303-3041, United States

Location

Associates in Oncology and Hematology

Chattanooga, Tennessee, 37404, United States

Location

McLeod Cancer and Blood Center

Johnson City, Tennessee, 37604, United States

Location

University of Tennessee

Knoxville, Tennessee, 37920, United States

Location

Texas Cancer Center

Arlington, Texas, 76014, United States

Location

Texas Oncology Cancer Center

Austin, Texas, 78731, United States

Location

Texas Cancer Center (Dallas Southwest)

Dallas, Texas, 75237, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75246, United States

Location

Texas Cancer Center / Denton

Denton, Texas, 76210, United States

Location

El Paso Cancer Treatment Center--East

El Paso, Texas, 79915, United States

Location

Texas Oncology, PA

El Paso, Texas, 79915, United States

Location

Texas Oncology, PA

Fort Worth, Texas, 76104, United States

Location

US Oncology Research and Clinical Pharmacy

Fort Worth, Texas, 76177, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410, United States

Location

Texas Oncology, PA

Mesquite, Texas, 75150, United States

Location

Texas Oncology, PA / Allison Cancer Center

Midland, Texas, 79701-5946, United States

Location

West Texas Cancer Center

Odessa, Texas, 79761, United States

Location

Paris Regional Cancer Center

Paris, Texas, 75460-5004, United States

Location

Texas Oncology Cancer Center--Sugar Land

Sugar Land, Texas, 77479, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Cancer Outreach Associates, PC / Outreach Clinical Trial Consortium LLC

Abingdon, Virginia, 24211, United States

Location

Fairfax Northern Virginia Hematology / Oncology, PC

Fairfax, Virginia, 22031, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Virginia Physicians, Inc.

Richmond, Virginia, 23229, United States

Location

Oncology & Hematology Associates of Southwest Virginia

Salem, Virginia, 24153, United States

Location

Luke Walker, MD

Everett, Washington, 98206, United States

Location

Cascade Cancer Center

Kirkland, Washington, 98034-3013, United States

Location

Puget Sound Cancer Centers

Seattle, Washington, 98133, United States

Location

Cancer Care Northwest

Spokane, Washington, 99218, United States

Location

Northwest Cancer Specialists, PC

Vancouver, Washington, 98684, United States

Location

Medical Consultants, Ltd.

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

talabostat; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 10, 2006
• Study Start: February 1, 2006
• Last Updated: June 8, 2007

Record last verified: 2007-06

Locations

US (101)