A Phase 2, Double-Blind, Placebo-Controlled Study of IPI-504 and Docetaxel in Previously Treated Patients With Stage IIIB or IV Non-Small Cell Lung Cancer
This is a Phase 2, double-blind, randomized, placebo-controlled study in patients with
previously treated, locally advanced or metastatic Stage IIIb or IV NSCLC designed to
compare IPI-504 plus docetaxel versus placebo plus docetaxel. All patients will have at
least a 15 pack year smoking history. Tumor samples will be assessed by a central pathology
reviewer to confirm pathology that is documented at baseline; this review need not occur in
advance of randomization.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Overall Survival
To determine the overall survival rate of patients administered IPI-504 plus docetaxel vs. placebo plus docetaxel
Up to three years from last patient study visit
No
Tess Schmalbach, MD
Study Director
Infinity Pharmaceuticals, Inc.
United States: Food and Drug Administration
IPI 504-14
NCT01362400
May 2011
December 2013
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
Yale Cancer Center | New Haven, Connecticut 06520-8028 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Wilshire Oncology Medical Group, Inc. | Rancho Cucamonga, California 91730 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Community Hospital | Munster, Indiana 46321 |
University of Rochester | Rochester, New York 14642 |
Arizona Oncology Associates | Tucson, Arizona 85712-2254 |
Providence Portland Medical Center | Portland, Oregon 97213-3635 |
Sarah Cannon Cancer Center | Nashville, Tennessee 37203 |
Oncology Hematology Care, Inc. | Cincinnati, Ohio 45219 |
Blumenthal Cancer Center | Charlotte, North Carolina 28203 |
Virginia Cancer Institute | Richmond, Virginia 23230 |
Central Indiana Cancer Centers | Indianapolis, Indiana 46227 |
Broome Oncology, LLC | Johnson City, New York 13790 |
Indiana University | Indianapolis, Indiana 46202 |
Karmanos Cancer Institute | Detroit, Michigan 48201 |
Piedmont Hematology Oncology Associates, PLLC | Winston-Salem, North Carolina |
University of California Irvine Medical Center | Orange, California 92668 |
Puget Sound Cancer Centers | Edmonds, Washington 98026 |
Southeast Nebraska Cancer Center | Lincoln, Nebraska 68510 |
Tulane University | New Orleans, Louisiana 70112-2699 |
Charleston Hematology Oncology Associates, PA | Charleston, South Carolina 29403 |
Signal Point Clinical Research Center, LLC | Middletown, Ohio 45042 |
Willamette Valley Cancer Institute and Research Center | Springfield, Oregon 97477 |
Texas Oncology-Tyler | Tyler, Texas 75702 |
Chattanooga Oncology and Hematology Associates, PC | Chattanooga, Tennessee 37404 |
Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas, Texas 75246 |
Ironwood Cancer and Research Center | Chandler, Arizona 85224 |
American Institute of Research | Whittier, California 90603 |
Floyd Memorial Cancer Center of Indiana | New Albany, Indiana 47150 |
PMK Medical Group, Inc. | Oxnard, California 93030 |
Florida Cancer Specialists and Research Institute | Saint Petersburg, Florida 33705 |
Indiana University Health Ball Memorial Hospital | Muncie, Indiana 47303 |
Owsley Brown Frazier Cancer Center-Louisville Downtown | Louisville, Kentucky 40215 |
Ann Arbor Hematology Oncology Associates | Ann Arbor, Michigan 48158 |
Metro Health Cancer Center | Wyoming, Michigan 49519 |
Texas Oncology-Arlington South | Arlington, Texas 76014 |
University of Utah Hospital and Clinics | Salt Lake City, Utah 84112 |