A Double-blind Study Evaluating IPI-504 and Docetaxel in Patients With Non-Small Cell Lung Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

226

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

March 31, 2014

Study Completion Date

April 30, 2014

Conditions
Non Small Cell Lung Cancer
Interventions
DRUG

IPI 504 plus Docetaxel

"450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 \& 15 during each 21 day cycle~75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle)"

DRUG

Placebo plus Docetaxel

"450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 \& 15 during each 21 day cycle~75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle)"

Trial Locations (65)

1121

Országos Korányi TBC és Pulmonológiai Intézet, Budapest

1529

Országos Korányi TBC és Pulmonológiai Intézet, Budapest

3233

Mátrai Gyógyintézet, Mátraháza

5703

Pándy Kálmán Megyei Kórház, Gyula

8900

Zala Megyei Kórház, Zalaegerszeg

9400

Sopron MJV Erzsébet Kórház, A DEOEC Oktató Kórháza, Sopron

10002

National Taiwan University Hospital, Taipei

11490

Tri-Service General Hospital, Taipei

13790

Broome Oncology, LLC, Johnson City

14642

Memorial Sloan-Kettering Cancer Center, New York

University of Rochester, Rochester

23230

Virginia Cancer Institute, Richmond

27103

Piedmont Hematology Oncology Associates, PLLC, Winston-Salem

28203

Blumenthal Cancer Center, Charlotte

29414

Charleston Hematology Oncology Associates, PA, Charleston

29672

Cancer Centers of the Carolinas, Seneca

33705

Florida Cancer Specialists and Research Institute, St. Petersburg

33916

Florida Cancer Specialists, Fort Myers

37203

Sarah Cannon Cancer Center, Nashville

37404

Chattanooga Oncology and Hematology Associates, PC, Chattanooga

40215

Owsley Brown Frazier Cancer Center-Louisville Downtown, Louisville

40447

China Medical University Hospital, Taichung

40705

Taichung Veterans General Hospital, Taichung

45042

Signal Point Clinical Research Center, LLC, Middletown

45242

Oncology Hematology Care, Inc., Cincinnati

46032

Central Indiana Cancer Centers, Carmel

46202

Indiana University, Indianapolis

46321

Community Hospital, Munster

47150

Floyd Memorial Cancer Center of Indiana, New Albany

47303

Indiana University Health Ball Memorial Hospital, Muncie

48158

Ann Arbor Hematology Oncology Associates, Ann Arbor

48201

Karmanos Cancer Institute, Detroit

48912

Sparrow Regional Cancer Center, Lansing

49519

Metro Health Cancer Center, Wyoming

68510

Southeast Nebraska Cancer Center, Lincoln

70112

Tulane University, New Orleans

75246

Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas

75702

Texas Oncology-Tyler, Tyler

76014

Texas Oncology-Arlington South, Arlington

84112

University of Utah Hospital and Clinics, Salt Lake City

85224

Ironwood Cancer and Research Center, Chandler

90603

American Institute of Research, Whittier

91730

Wilshire Oncology Medical Group, Inc., Rancho Cucamonga

92868

University of California Irvine Medical Center, Orange

93030

PMK Medical Group, Inc., Oxnard

97213

Providence Portland Medical Center, Portland

97401

Willamette Valley Cancer Institute and Research Center, Eugene

98026

Puget Sound Cancer Centers, Edmonds

100337

Spitalul Municipal Ploiesti, Ploieşti

115478

Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology, Moscow

129128

"Non-State Central Clinical Hospital # 2 named N.A. Semashko of OAO RGD", Moscow

143423

City Oncology Hospital # 62, Moscow Region

400015

"Institutul Oncologic Prof. Dr. I. Chiricuta", Cluj-Napoca

430031

"Spitalul de Urgenta Constantin Opris", Baia Mare

454087

"State Budget Institution of Healthcare Chelyabinsk Regional Clinical Oncology Dispensary", Chelaybinsk

500245

Spitalul Clinic Judetean de Urgenta Sibiu, Sibiu

85715-4900

Arizona Oncology Associates, Tucson

06519

Yale Cancer Center, New Haven

02114

Massachusetts General Hospital, Boston

411-769

National Cancer Center, Goyang-si

400-711

Inha University Hospital, Jung Gu

519-763

Chonnam National University Hwasun Hospital, Hwasun

602-715

Dong-A University Medical Center, Busan

120-752

Severance Hospital,Yonsei University Health System, Seoul

138-876

Asan Medical Center, Seoul

Sponsors
All Listed Sponsors
lead

Infinity Pharmaceuticals, Inc.

INDUSTRY