Study Stopped
FDA Hold May 2007
Study of Talabostat + Docetaxel Versus Docetaxel in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy
1 other identifier
interventional
400
1 country
96
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2005
CompletedFirst Posted
Study publicly available on registry
October 21, 2005
CompletedStudy Start
First participant enrolled
January 1, 2006
CompletedJune 8, 2007
June 1, 2007
October 19, 2005
June 7, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (96)
Marshall Schreeder, MD
Huntsville, Alabama, 35801, United States
James P. Daugherty, MD
Muscle Shoals, Alabama, 35661, United States
Alaska Cancer Research
Anchorage, Alaska, 99508, United States
Hematology Oncology Associates
Phoenix, Arizona, 85012, United States
Veena Charu, MD
Anaheim, California, 92801, United States
Lalita Pandit, MD, Inc
Fountain Valley, California, 92708, United States
Robert A. Moss, MD, FACP, Inc.
Fountain Valley, California, 92708, United States
Warren Paroly, MD
Oceanside, California, 92056, United States
Swarna S. Chanduri, MD
Pomona, California, 91767, United States
Southwest Cancer Care Medical Group
Poway, California, 92064-2527, United States
Mile High Oncology
Denver, Colorado, 80210, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Medical Specialists of Fairfield
Fairfield, Connecticut, 06824, United States
Pasco Hernando Oncology Associates PA
Brooksville, Florida, 34613, United States
Lucio Gordan, MD
Gainesville, Florida, 32605, United States
Citrus Hematology and Oncology Center
Inverness, Florida, 34452, United States
Nature Coast Clinical Research, LLC
Inverness, Florida, 34452, United States
Jorge G. Otoya, MD
Kissimmee, Florida, 34741, United States
Cancer and Blood Disease Center
Lecanto, Florida, 34461, United States
Pasco Hernando Oncology Associates, PA
New Port Richey, Florida, 34652, United States
Ocala Oncology Center
Ocala, Florida, 34474, United States
Cancer Center of Florida
Ocoee, Florida, 34761, United States
Hematology Oncology Associates of Illinois
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Joliet Oncology Hematology Associates
Joliet, Illinois, 60435, United States
Indiana Hematology Oncology Consultants
Indianapolis, Indiana, 46202, United States
Northern Indiana Oncology Associates
South Bend, Indiana, 46617, United States
Kansas City Cancer Centers, Southwest
Overland Park, Kansas, 66210, United States
Kentucky Cancer Clinic
Hazard, Kentucky, 41701, United States
Medical Oncology, LLC
Baton Rouge, Louisiana, 70809, United States
Maryland Oncology Hematology, PA
Columbia, Maryland, 21044, United States
Chesapeake Oncology Hematology Associates (Tate Center)
Glen Burnie, Maryland, 21061, United States
Josephine Ford Cancer Center -- Downriver
Brownstown, Michigan, 48183, United States
Michael McKenzie, DO
Clinton Township, Michigan, 48038, United States
Henry Ford Medical Center -- Fairlane
Dearborn, Michigan, 48126, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Youssef Hanna, MD
Port Huron, Michigan, 48060, United States
Cancer and Transplant Consultants, PLC
Rochester Hills, Michigan, 48307, United States
Cancer Care Associates
Rochester Hills, Michigan, 48307, United States
Cancer Care Associates, PC
Royal Oak, Michigan, 48073, United States
Hematology Oncology Consultants
Royal Oak, Michigan, 48073, United States
Jeffrey H. Margolis, MD
Royal Oak, Michigan, 48073, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Oncology Care Associates, PLLC
Saint Joseph, Michigan, 49085, United States
Michigan Hematology and Oncology Institute
Southgate, Michigan, 48195, United States
Mitchell Folbe, MD, PC
Troy, Michigan, 48085, United States
William Beaumont Hospital
Troy, Michigan, 48085, United States
Henry Ford Medical Center
West Bloomfield, Michigan, 48322, United States
St. Joseph Oncology, Inc.
Saint Joseph, Missouri, 64507, United States
Arch Medical Services, Inc.
St Louis, Missouri, 63141, United States
Billings Clinic
Billings, Montana, 59101, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89109, United States
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003, United States
New York Oncology Hematology, PC
Albany, New York, 12208, United States
George A. Zervos, MD
Glen Head, New York, 11545, United States
Northwestern Carolina Oncology Hematology
Hickory, North Carolina, 28602, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Oncology/Hematology Care, Inc.
Cincinnati, Ohio, 45242, United States
Gabrail Cancer Center
Dover, Ohio, 44622, United States
Dayton Hematology and Oncology
Kettering, Ohio, 45409, United States
Mukesh C. Bhatt, MD
Medina, Ohio, 44256, United States
Trilogy Cancer Center
Wooster, Ohio, 44691, United States
Cancer Care Associates
Oklahoma City, Oklahoma, 73112, United States
Cancer Care Associates
Tulsa, Oklahoma, 74136, United States
Northwest Cancer Specialists, Northrup
Portland, Oregon, 97210, United States
Shatish A. Shah, MD
Gettysburg, Pennsylvania, 17325, United States
Medical Oncology Associates of Wyoming Valley, PC
Kingston, Pennsylvania, 18704, United States
Rittenhouse Hematology Oncology Associates
Philadelphia, Pennsylvania, 19146, United States
Chester County Hematology / Oncology Services
West Chester, Pennsylvania, 19380, United States
Cancer Care Institute of Carolina
Aiken, South Carolina, 29801, United States
Charleston Hematology Oncology, PA
Charleston, South Carolina, 29403, United States
Palmetto Hematology Oncology, PC
Spartanburg, South Carolina, 29303-3041, United States
Texas Cancer Center
Arlington, Texas, 76014, United States
Texas Oncology Cancer Center
Austin, Texas, 78731, United States
Texas Cancer Center (Dallas Southwest)
Dallas, Texas, 75237, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75246, United States
Texas Cancer Center / Denton
Denton, Texas, 76210, United States
El Paso Cancer Treatment Center
El Paso, Texas, 79915, United States
Texas Oncology, PA
Fort Worth, Texas, 76104, United States
US Oncology Research and Clinical Pharmacy
Fort Worth, Texas, 76177, United States
Texas Cancer Center of Mesquite
Mesquite, Texas, 75150, United States
Allison Cancer Center
Midland, Texas, 79701-5946, United States
West Texas Cancer Center
Odessa, Texas, 79761, United States
Paris Regional Cancer Center
Paris, Texas, 75460-5004, United States
Texas Oncology Cancer Center--Sugar Land
Sugar Land, Texas, 77479, United States
Annandale-Fairfax Virginia Hematology Oncology, PC
Fairfax, Virginia, 22031, United States
Peninsula Cancer Institute
Gloucester, Virginia, 23061, United States
Peninsula Cancer Institute
Newport News, Virginia, 23601, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.
Salem, Virginia, 24153, United States
Peninsula Cancer Institute
Williamsburg, Virginia, 23185, United States
Masoom Kandahari, MD, PC
Woodbridge, Virginia, 22191, United States
Puget Sound Cancer Centers
Seattle, Washington, 98133, United States
Jay L. Wittenkeller, MD
Spokane, Washington, 99204, United States
Cancer Care Northwest Research
Spokane, Washington, 99218, United States
Northwest Cancer Specialists, PC
Vancouver, Washington, 98684, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 19, 2005
First Posted
October 21, 2005
Study Start
January 1, 2006
Last Updated
June 8, 2007
Record last verified: 2007-06