A Study of BBI503 in Combination With Selected Anti-Cancer Therapeutics in Adult Patients With Advanced Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

165

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

May 31, 2019

Study Completion Date

May 31, 2019

Conditions
Cancer
Interventions
DRUG

BBI503

Patients in this trial will receive BBI503 orally, daily, and continuously. The dose-level of BBI503 will be assigned according to the dose-cohort open at the time the patient enrolls into a given arm. The study-arm and combination anti-cancer agent for a given patient will be determined by the investigator. BBI503 Dose Level 1: 200 mg once daily, Dose Level 2: 300 mg once daily.

DRUG

Capecitabine

Capecitabine 1000 mg/m\^2 body surface area is administered orally, twice daily, on days 1-14 of each 21 day cycle.

DRUG

Doxorubicin

Doxorubicin 60 mg/m\^2 body surface area is administered intravenously once every three weeks (21-days).

DRUG

Nivolumab

Nivolumab 3 mg/kg is administered as an intravenous infusion over 60 minutes on day 1 and day 15 of each 28 day cycle.

DRUG

Pembrolizumab

Pembrolizumab 2 mg/kg is administered as an intravenous infusion over 30 minutes once every three weeks (21-days).

DRUG

Paclitaxel

Paclitaxel 80 mg/m\^2 body surface area is administered intravenously once weekly on day 1, day 8, and day 15 of each 28 day cycle.

DRUG

Sunitinib

Sunitinib 37.5 mg is administered once daily.

Trial Locations (8)

46526

Indiana University Health Goshen, Goshen

Unknown

Parkview Research Center, Fort Wayne

Indiana University -Ball, Indianapolis

Indiana University-SCC, Indianapolis

Louisiana State Univesity, New Orleans

US Oncology Research, Fairfax

Ottawa Hospital Research Institute, Ottawa

Princess Margaret Cancer Centre, Toronto

All Listed Sponsors
lead

Sumitomo Pharma America, Inc.

INDUSTRY

NCT02483247 - A Study of BBI503 in Combination With Selected Anti-Cancer Therapeutics in Adult Patients With Advanced Cancer | Biotech Hunter | Biotech Hunter