Study of the Safety and Efficacy of TH-302 in Combination With Gemcitabine Compared With Gemcitabine Alone in Previously Untreated Patients With Pancreatic Adenocarcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

214

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

September 30, 2013

Study Completion Date

December 31, 2014

Conditions
Pancreatic Adenocarcinoma
Interventions
DRUG

Gemzar (Gemcitabine)

1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.

DRUG

TH-302

240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.

DRUG

TH-302

340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.

Trial Locations (59)

12534

New York Oncology Hematology, P.C., Hudson

14263

Roswell Park Cancer Institute, Buffalo

15212

Allegheny General Hospital, Pittsburgh

15232

University of Pittsburgh Medical Center, Pittsburgh

19114

Greater Philadelphia Cancer and Hematology Specialists, P.C., Philadelphia

22031

Fairfax Northern Virginia Hematology Oncology, PC, Fairfax

27262

Emerywood Hematology and Oncology, High Point

27599

Alamance Oncology Hematolgy Associates, Burlington

27710

Duke University Medical Center, Durham

28602

Carolina Oncology Specialists, PA, Hickory

28801

Cancer Care of Western North Carolina, PA, Asheville

29605

Institute for Translational Oncology Research (ITOR), Greenville

30342

Atlanta Cancer Care, Atlanta

34471

Ocala Oncology Center, Ocala

34655

Florida Cancer Institute - New Hope, New Port Richey

34994

Martin Memorial Cancer Center, Stuart

35223

Birmingham Hematology and Oncology Associates, LLC, Birmingham

37232

Vanderbilt University Medical Center, Div. of Medical Oncology, Nashville

38801

Hematology and Oncology Associates at BridgePoint, Tupelo

42002

Purchase Cancer Group, Paducah

45042

Signal Point Clinical Research Center, Middletown

46202

Indiana University Melvin and Bren Simon Cancer, Indianapolis

53792

University of Wisconsin, Madison

55407

Virgina Piper Cancer Institute, Minneapolis

55905

Mayo Clinic Rochester, Rochester

59802

Montana Cancer Institute Foundation, Missoula

60153

Loyola University Medical Center, Maywood

61901

Carle Cancer Center, Urbana

65201

Missouri Cancer Associates, Columbia

70121

Ochsner Cancer Institute, New Orleans

70809

Medical Oncology, Baton Rouge

71130

LSU Health Sciences Center - Feist Weiller Cancer Center, Shreveport

72917

Saint Edward Mercy Medical Center, Fort Smith

75090

Texas Oncology-Sherman, Sherman

75231

Texas Oncology-Dallas Presbyterian Hospital, Dallas

75390

University of Texas Southwestern Medical Center at Dallas, Dallas

76104

Texas Oncology- Fort Worth - 12th Avenue, Fort Worth

76310

Texas Oncology-Wichita Falls Texoma Cancer Center, Wichita Falls

77702

Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center, Beaumont

78665

Texas Oncology-Seton Williamson, Round Rock

80218

Rocky Mountain Cancer Centers, Denver

85259

Mayo Clinic Arizona, Scottsdale

85704

Arizona Oncology Associates, PC - HOPE, Tucson

85724

University of Arizona, Tucson

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

90095

UCLA Medical Center, Los Angeles

91505

Disney Family Cancer Center, Burbank

92037

Scripps Clinical Research Services, La Jolla

92123

Sharp Memorial Hospital, San Diego

93901

Los Palos Oncology and Hematology, Salinas

94040

Palo Alto Medical Foundation, Mountain View

94115

California Pacific Medical Center, San Francisco

97227

Kaiser Permanente Northwest Region Oncology Hematology, Portland

Northwest Cancer Specialists, P.C., Portland

98201

Providence Everett Regional Medical Center, Cancer Research Dept., Everett

99336

Columbia Basin Hematology and Oncology0, Kennewick

06902

Hematology Oncology Associates, PC, Stamford

02114

Massachusetts General Hospital, Boston

01655

University of Massachusetts Medical Center, Worcester

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

PRA Health Sciences

INDUSTRY

lead

ImmunoGenesis

INDUSTRY