Study of Talabostat and Pemetrexed vs. Pemetrexed in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy
- Conditions
- Carcinoma, Non-Small-Cell LungLung CancerNeoplasms, LungNeoplasms, Pulmonary
- Registration Number
- NCT00290017
- Lead Sponsor
- Point Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 400
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (95)
Texas Cancer Center (Dallas Southwest)
🇺🇸Dallas, Texas, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Oncology/Hematology Care, Inc.
🇺🇸Cincinnati, Ohio, United States
University of Tennessee
🇺🇸Knoxville, Tennessee, United States
Kansas City Cancer Center, LLC
🇺🇸Overland Park, Kansas, United States
Hematology Oncology Associates
🇺🇸Phoenix, Arizona, United States
Raul R. Mena, MD
🇺🇸Burbank, California, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Cancer and Blood Disease Center
🇺🇸Lecanto, Florida, United States
Southwest Cancer Care Medical Group
🇺🇸Poway, California, United States
Jeffrey H. Margolis, MD
🇺🇸Royal Oak, Michigan, United States
Minnesota Oncology Hematology, PA
🇺🇸Minneapolis, Minnesota, United States
Chesapeake Oncology Hematology Associates (Tate Center)
🇺🇸Glen Burnie, Maryland, United States
Associated Physicians and Surgeons, LLC
🇺🇸Terre Haute, Indiana, United States
Hematology Oncology Associates of Illinois
🇺🇸Chicago, Illinois, United States
Eugene Paschold, MD
🇺🇸Winston Salem, North Carolina, United States
Warren Paroly, MD
🇺🇸Oceanside, California, United States
Lucio Gordan, MD
🇺🇸Gainesville, Florida, United States
Arnett Cancer Center
🇺🇸Lafayette, Indiana, United States
Dayton Oncology & Hematology, PA
🇺🇸Kettering, Ohio, United States
Puget Sound Cancer Centers
🇺🇸Seattle, Washington, United States
Texas Oncology Cancer Center
🇺🇸Austin, Texas, United States
New York Oncology Hematology, PC
🇺🇸Albany, New York, United States
Texas Oncology Cancer Center--Sugar Land
🇺🇸Sugar Land, Texas, United States
Hematology Oncology Consultants
🇺🇸Royal Oak, Michigan, United States
William Beaumont Hospital
🇺🇸Troy, Michigan, United States
Kentucky Cancer Clinic
🇺🇸Hazard, Kentucky, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Cancer Center of Florida
🇺🇸Ocoee, Florida, United States
HUX Cancer Center/Union Hospital
🇺🇸Terre Haute, Indiana, United States
Joliet Oncology-Hematology Associates
🇺🇸Joliet, Illinois, United States
Rittenhouse Hematology Oncology Associates
🇺🇸Philadelphia, Pennsylvania, United States
Texas Cancer Center
🇺🇸Arlington, Texas, United States
St. Joseph Oncology, Inc.
🇺🇸St. Joseph, Missouri, United States
Cancer Care Associates, PC
🇺🇸Royal Oak, Michigan, United States
Medical Oncology Associates of Wyoming Valley, PC
🇺🇸Kingston, Pennsylvania, United States
Paoli Hospital
🇺🇸Paoli, Pennsylvania, United States
Texas Cancer Center / Denton
🇺🇸Denton, Texas, United States
Texas Oncology, PA
🇺🇸Mesquite, Texas, United States
US Oncology Research and Clinical Pharmacy
🇺🇸Ft. Worth, Texas, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Luke Walker, MD
🇺🇸Everett, Washington, United States
Cascade Cancer Center
🇺🇸Kirkland, Washington, United States
Oncology & Hematology Associates of Southwest Virginia
🇺🇸Salem, Virginia, United States
Bux-Mont Oncology-Hematology
🇺🇸Sellersville, Pennsylvania, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Northwestern Carolina Oncology & Hematology, PA
🇺🇸Hickory, North Carolina, United States
Satish A. Shah, MD
🇺🇸Gettysburg, Pennsylvania, United States
Hematology-Oncology Group, PC
🇺🇸Langhorne, Pennsylvania, United States
Pottstown Memorial Medical Center
🇺🇸Pottstown, Pennsylvania, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
St. Mary Medical Center--Research Center
🇺🇸Langhorne, Pennsylvania, United States
West Texas Cancer Center
🇺🇸Odessa, Texas, United States
Mary Crowley Medical Research Center
🇺🇸Dallas, Texas, United States
Paris Regional Cancer Center
🇺🇸Paris, Texas, United States
Texas Oncology, PA / Allison Cancer Center
🇺🇸Midland, Texas, United States
Cancer Outreach Associates, PC / Outreach Clinical Trial Consortium LLC
🇺🇸Abingdon, Virginia, United States
Cancer Care Northwest
🇺🇸Spokane, Washington, United States
Virginia Physicians, Inc.
🇺🇸Richmond, Virginia, United States
Pacific Coast Hematology / Oncology Medical Group, Inc.
🇺🇸Fountain Valley, California, United States
Heritage Physician Group-Oncology
🇺🇸Hot Springs, Arkansas, United States
Robert A. Moss, MD, FACP, Inc.
🇺🇸Fountain Valley, California, United States
Marshall Schreeder, MD
🇺🇸Huntsville, Alabama, United States
Antelope Valley Cancer Center
🇺🇸Lancaster, California, United States
Northeast Georgia Cancer Care, LLC
🇺🇸Athens, Georgia, United States
North Idaho Cancer Center
🇺🇸Coeur d'Alene, Idaho, United States
Fallon Clinic, Inc. at Worcester Medical Center
🇺🇸Worcester, Massachusetts, United States
American Health Network of Indiana--Hematology/Oncology
🇺🇸Indianapolis, Indiana, United States
Northern Indiana Oncology Associates
🇺🇸South Bend, Indiana, United States
Cancer Care Associates
🇺🇸Tulsa, Oklahoma, United States
Carroll County Cancer Center
🇺🇸Westminster, Maryland, United States
Youssef Hanna, MD
🇺🇸Port Huron, Michigan, United States
Michael McKenzie, DO
🇺🇸Clinton Township, Michigan, United States
Cancer and Transplant Consultants, PLC
🇺🇸Rochester Hills, Michigan, United States
Dr. Folbe, MD/PC
🇺🇸Troy, Michigan, United States
McLeod Cancer and Blood Center
🇺🇸Johnson City, Tennessee, United States
El Paso Cancer Treatment Center--East
🇺🇸El Paso, Texas, United States
Grandview Hospital
🇺🇸Sellersville, Pennsylvania, United States
Associates in Oncology and Hematology
🇺🇸Chattanooga, Tennessee, United States
Fairfax Northern Virginia Hematology / Oncology, PC
🇺🇸Fairfax, Virginia, United States
Northwest Cancer Specialists, PC
🇺🇸Vancouver, Washington, United States
Medical Consultants, Ltd.
🇺🇸Milwaukee, Wisconsin, United States
Piedmont Hematology Oncology / Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
Mile High Oncology
🇺🇸Denver, Colorado, United States
Charleston Hematology Oncology, PA
🇺🇸Charleston, South Carolina, United States
Palmetto Hematology Oncology PC
🇺🇸Spartanburg, South Carolina, United States
Mercer Bucks Oncology/Hematology
🇺🇸Trenton, New Jersey, United States
VA Sierra Nevada Health Care System
🇺🇸Reno, Nevada, United States
Medical Specialists of Fairfield
🇺🇸Fairfield, Connecticut, United States
Capital Health System
🇺🇸Trenton, New Jersey, United States
Northwestern Connecticut Oncology Hematology Associates, LLP
🇺🇸Torrington, Connecticut, United States
Cancer Care Institute of Carolina
🇺🇸Aiken, South Carolina, United States
Hunterdon Regional Cancer Center
🇺🇸Flemington, New Jersey, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
Hematology Oncology Associates, SJ, PA
🇺🇸Mount Holly, New Jersey, United States