Spots Global Cancer Trial Database for A Double-blind Study Evaluating IPI-504 and Docetaxel in Patients With Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: A Double-blind Study Evaluating IPI-504 and Docetaxel in Patients With Non-Small Cell Lung Cancer
Official Title: 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
Study ID: NCT01362400
Conditions
Study Description
Brief Summary: The purpose of this study is to compare the impact of IPI-504 in combination with docetaxel to placebo in combination with docetaxel on life expectancy in patients with Non Small Cell Lung cancer (NSCLC). Docetaxel is an approved chemotherapy for NSCLC. An additional goal of the study is to determine the effect of IPI-504, in combination with docetaxel, verses placebo in, combination with docetaxel, on the growth of cancer
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ironwood Cancer and Research Center, Chandler, Arizona, United States
Arizona Oncology Associates, Tucson, Arizona, United States
University of California Irvine Medical Center, Orange, California, United States
PMK Medical Group, Inc., Oxnard, California, United States
Wilshire Oncology Medical Group, Inc., Rancho Cucamonga, California, United States
American Institute of Research, Whittier, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Florida Cancer Specialists and Research Institute, Saint Petersburg, Florida, United States
Central Indiana Cancer Centers, Carmel, Indiana, United States
Indiana University, Indianapolis, Indiana, United States
Indiana University Health Ball Memorial Hospital, Muncie, Indiana, United States
Community Hospital, Munster, Indiana, United States
Floyd Memorial Cancer Center of Indiana, New Albany, Indiana, United States
Owsley Brown Frazier Cancer Center-Louisville Downtown, Louisville, Kentucky, United States
Tulane University, New Orleans, Louisiana, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Ann Arbor Hematology Oncology Associates, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
Metro Health Cancer Center, Wyoming, Michigan, United States
Southeast Nebraska Cancer Center, Lincoln, Nebraska, United States
Broome Oncology, LLC, Johnson City, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
Blumenthal Cancer Center, Charlotte, North Carolina, United States
Piedmont Hematology Oncology Associates, PLLC, Winston Salem, North Carolina, United States
Piedmont Hematology Oncology Associates, PLLC, Winston-Salem, North Carolina, United States
Oncology Hematology Care, Inc., Cincinnati, Ohio, United States
Signal Point Clinical Research Center, LLC, Middletown, Ohio, United States
Willamette Valley Cancer Institute and Research Center, Eugene, Oregon, United States
Providence Portland Medical Center, Portland, Oregon, United States
Charleston Hematology Oncology Associates, PA, Charleston, South Carolina, United States
Cancer Centers of the Carolinas, Seneca, South Carolina, United States
Chattanooga Oncology and Hematology Associates, PC, Chattanooga, Tennessee, United States
Sarah Cannon Cancer Center, Nashville, Tennessee, United States
Texas Oncology-Arlington South, Arlington, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology-Tyler, Tyler, Texas, United States
University of Utah Hospital and Clinics, Salt Lake City, Utah, United States
Virginia Cancer Institute, Richmond, Virginia, United States
Puget Sound Cancer Centers, Edmonds, Washington, United States
Pándy Kálmán Megyei Kórház, Gyula, Bekes, Hungary
Sopron MJV Erzsébet Kórház, A DEOEC Oktató Kórháza, Sopron, Gyor-moson-sopron, Hungary
Mátrai Gyógyintézet, Mátraháza, Heves, Hungary
Zala Megyei Kórház, Zalaegerszeg, Zala, Hungary
Országos Korányi TBC és Pulmonológiai Intézet, Budapest, , Hungary
Országos Korányi TBC és Pulmonológiai Intézet, Budapest, , Hungary
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Inha University Hospital, Jung Gu, Incheon, Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, Jeollanam-do, Korea, Republic of
Dong-A University Medical Center, Busan, , Korea, Republic of
Severance Hospital,Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Institutul Oncologic "Prof. Dr. I. Chiricuta", Cluj-Napoca, Cluj, Romania
Spitalul de Urgenta "Constantin Opris", Baia Mare, Maramures, Romania
Spitalul Municipal Ploiesti, Ploiesti, Prahova, Romania
Spitalul Clinic Judetean de Urgenta Sibiu, Sibiu, , Romania
City Oncology Hospital # 62, Moscow Region, Moscow, Russian Federation
State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary", Chelaybinsk, , Russian Federation
Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology, Moscow, , Russian Federation
Non-State Central Clinical Hospital # 2 named N.A. Semashko of "OAO RGD", Moscow, , Russian Federation
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Tri-Service General Hospital, Taipei, , Taiwan
Contact Details
Name: Tess Schmalbach, MD
Affiliation: Infinity Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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