NCT02483247

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

A Phase Ib/II Clinical Study of BBI503 in Combination With Selected Anti-Cancer Therapeutics in Adult Patients With Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, multi-center, Phase 1/2 study of BBI503 administered in combination with selected anti-cancer therapeutics in adult patients with advanced cancer. The goal of the study is to determine the safety, tolerability, and RP2D of BBI503 in combination with each of the selected anti-cancer agents.

Conditions

• Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2015-06-26
• Last updated: 2023-11-14

Locations

8 sites across 2 countries: United States, Canada