Study of Imprime PGG® in Combination With Cetuximab in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer

PHASE3TerminatedINTERVENTIONAL
Enrollment

217

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

February 28, 2017

Study Completion Date

February 28, 2017

Conditions
Colorectal Cancer
Interventions
BIOLOGICAL

Imprime PGG + cetuximab

Imprime PGG: 4 mg/kg and will be administered weekly in each cycle (Weeks 1-6/Days 1, 8, 15, 22, 29, and 36) preceding the administration of cetuximab Cetuximab: initial dose will be 400 mg/m2 on Cycle 1/Day 1 and subsequent doses will be 250 mg/m2, administered weekly in each cycle (Weeks 1-6/Days 1, 8, 15, 22, 29, and 36)

DRUG

Cetuximab

Cetuximab: initial dose will be 400 mg/m2 on Cycle 1/Day 1 and subsequent doses will be 250 mg/m2, administered weekly in each cycle (Weeks 1-6/Days 1, 8, 15, 22, 29, and 36)

Trial Locations (53)

12534

New York Oncology, Hematology, P.C., Hudson

13057

Hematology and Oncology Associates of Central NY, East Syracuse

13347

Medizinisches Versorgungszentrum Ãrzteforum Seestrabe, Berlin

16761

Ãrzteforum Henningsdorf Darmzentrum Oberhavel, Hennigsdorf

23606

Virginia Oncology Associates, Newport News

24014

Oncology and Hematology Associates of Southwest Virginia, Inc., dba Blue Ridge Cancer Care, Roanoke

29307

Cancer Centers of the Carolinas, Spartanburg

32806

MD Anderson Cancer Center, Orlando

33169

AMPM Research Clinic, Miami Gardens

34125

Klinikum Kassel GmbH Medizinische Klinik IV Onkologie, Hämatologie, Immunologie, Kassel, Hessen

35630

Northwest Alabama Cancer Center, Florence

37915

Tennessee Cancer Specialists, Knoxville

38138

The Jones Clinic, Germantown

39104

Schwerpunktpraxis für Hämatologie und Onkologie, Magdeburg

40202

University of Louisville/James Brown Cancer Center, Louisville

42283

Petruskrankenhaus Wuppertal, Klinik fuer Innere Medizin II- Gastroenterologie, Hepatologie und Diabetologie, Wuppertal

43623

Toledo Community Oncology Program- Toledo Community Hospital, Toledo

45042

Signal Point Hematology/Oncology, Middletown

46237

Indiana University Cancer Center, Beech Grove

48202

Henry Ford Health System, Detroit

50937

Universitätsklinikum Köln - Studienzentrum der Klinik I für Innere Medizin, Koeln, Nordrhein Westfalen

54000

Centre d' Oncologie de Gentilly, Nancy

55455

University of Minnesota, Minneapolis

60714

Illinois Cancer Specialists, Niles

61401

Medical and Surgical Specialists, Galesburg

65203

Ellis Fischel Cancer Center at University of Missouri- Columbia, Columbia

68130

Oncology Hematology West PC dba Nebraska Cancer Specialists, Omaha

70121

Ochsner Clinic Foundation, New Orleans

72703

Highlands Oncology Group, Bentonville

75067

Texas Oncology - Lewisville, Lewisville

75090

Texas Oncology - Sherman, Sherman

75201

Mary Crowley Cancer Research Center, Dallas

75231

Texas Oncology - Dallas Presbyterian Hospital, Dallas

75246

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

75702

Texas Oncology - Tyler, Tyler

76104

Texas Oncology - Fort Worth, Fort Worth

76210

Texas Oncology Denton South, Denton

78217

Cancer Care Centers of South Texas, San Antonio

78665

Texas Oncology-Seton Williamson, Round Rock

79106

Texas Oncology-Amarillo, Amarillo

84403

Northern Utah Associates, Ogden

89081

Universitaetsklinikum Ulm, Ulm

90057

Kenmar Research Institute, Los Angeles

91505

Providence St. Joseph Medical Center, Burbank

92801

Pacific Medical Center, Anaheim

92903

UCSD Moores Cancer Center, La Jolla

93309

Comprehensive Blood and Cancer Center, Bakersfield

96813

University of Hawaii Cancer Center, Honolulu

97213

Providence Portland Medical Center, Portland

97401

Willamette Valley Cancer Institute and Research Center, Eugene

02114

Massachusetts General Hospital, Boston

02115

Dana Farber Cancer Institute, Boston

00927

Fundacion de Investigacion de Diego, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

HiberCell, Inc.

INDUSTRY

NCT01309126 - Study of Imprime PGG® in Combination With Cetuximab in Subjects With Recurrent or Progressive KRAS Wild Type Colorectal Cancer | Biotech Hunter | Biotech Hunter