A Study of BBI608 in Combination With Sorafenib, or BBI503 in Combination With Sorafenib in Adult Patients With Hepatocellular Carcinoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

July 31, 2019

Study Completion Date

October 31, 2019

Conditions
Hepatocellular Carcinoma
Interventions
DRUG

BBI608

BBI608 will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study.

DRUG

BBI503

BBI503 will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study.

DRUG

Sorafenib

Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.

Trial Locations (29)

12206

USOR - New York Oncology Hematology, Albany

14642

University of Rochester, Wilmot Cancer Institute, Rochester

19102

Drexel University, Philadelphia

24014

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

27157

Wake Forest Baptist Health, Winston-Salem

28204

Carolinas Health Care System, Charlotte

30318

Piedmont Cancer Institute, P.C., Atlanta

30322

Winship Cancer Institute of Emory University, Atlanta

33176

Baptist Health Medical Group Oncology, LLC, Miami

40202

Norton Cancer Institute, Louisville

45267

University of Cincinnati, Vontz Center, Cincinnati

48201

Karmanos Cancer Institute, Detroit

55404

Minnesota Oncology Hematology, P.A., Minneapolis

64131

Kansas City Research Institure, Kansas City

75246

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

75702

USOR - Texas Oncology, Tyler, Tyler

76104

USOR - Texas Oncology, Fort Worth 12th Ave, Fort Worth

77030

Oncology Consultants, Houston

78503

Texas Oncology-McAllen South Second Street, McAllen

78705

USOR - Texas Oncology, Austin Midtown, Austin

79938

Texas Oncology - El Paso Cancer Treatment Center Joe Battle, El Paso

80218

USOR - Rocky Mountain Cancer Centers, Denver

85054

Mayo Clinic, Phoenix

85234

Banner MD Anderson Cancer Center, Gilbert

89169

USOR - Comprehensive Cancer Centers of Nevada, Las Vegas

90033

USC Norris Comprehensive Cancer Center, Los Angeles

92024

California Center Associates for Research and Excellence, Inc. (Ccare), Encinitas

92118

Southern California Research Center, Coronado

07652

The Valley Hospital Luckow Pavilion, Paramus

All Listed Sponsors
lead

Sumitomo Pharma America, Inc.

INDUSTRY

NCT02279719 - A Study of BBI608 in Combination With Sorafenib, or BBI503 in Combination With Sorafenib in Adult Patients With Hepatocellular Carcinoma | Biotech Hunter | Biotech Hunter