A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Pancreatic Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

139

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

June 30, 2020

Study Completion Date

June 30, 2020

Conditions
Metastatic Pancreatic Adenocarcinoma
Interventions
DRUG

BBI608

Administered continuously twice daily with doses separated by 12 hours

DRUG

Nab-paclitaxel

Nab-paclitaxel 125 mg/m\^2 I.V. infusion on Days 1, 8, and 15 of every 28-day cycle

DRUG

Gemcitabine

Gemcitabine 1000 mg/m\^2 I.V. infusion on Days 1, 8, and 15 of every 28-day cycle

DRUG

Oxaliplatin

Oxaliplatin 85 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle

DRUG

Leucovorin

Arm C, D: Leucovorin 400 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle

DRUG

Irinotecan

Arm B: Irinotecan 165 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle, Arm C: Irinotecan 165 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle

DRUG

Fluorouracil

Arm B, D: Fluorouracil 2400 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle, Arm C: Fluorouracil 400 mg/m\^2 I.V. bolus followed by 2400 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle

DRUG

MM-398

MM-398 70 mg/m\^2 I.V. infusion on Days 1 and 15 of every 28-day cycle

Trial Locations (12)

23502

Virginia Oncology Associates, Norfolk

30322

Emory University Winship Cancer Institute, Atlanta

37920

The University of Tennessee Medical Center, Knoxville

43210

The Ohio State University Comprehensive Cancer Center, Columbus

46202

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

46526

Indiana University Health Goshen Center for Cancer Care, Goshen

46845

Parkview Research Center, Fort Wayne

75246

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

78216

Texas Oncology - SAT&BC, San Antonio

78705

Texas Oncology - Austin Midtown, Austin

85054

Mayo Clinic Arizona, Phoenix

89014

Comprehensive Cancer Centers of Nevada, Henderson

All Listed Sponsors
lead

Sumitomo Pharma America, Inc.

INDUSTRY

NCT02231723 - A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Pancreatic Cancer | Biotech Hunter | Biotech Hunter