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

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: BBI503; Drug: Pembrolizumab; Drug: Sunitinib; Drug: Capecitabine; Drug: Doxorubicin; Drug: Nivolumab; Drug: Paclitaxel

• Registration Number: NCT02483247
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-06-24
• Study First Posted: 2015-06-26
• Study Start: 2015-09
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combo with Doxorubicin	BBI503	-
Combo with Capecitabine	BBI503	-
Combo with Sunitinib	BBI503	-
Combo with Nivolumab (US only)	BBI503	-
Combo with Paclitaxel	BBI503	-
Combo with Pembrolizumab	BBI503	-
Combo with Pembrolizumab	Pembrolizumab	-
Combo with Sunitinib	Sunitinib	-
Combo with Capecitabine	Capecitabine	-
Combo with Doxorubicin	Doxorubicin	-
Combo with Nivolumab (US only)	Nivolumab	-
Combo with Paclitaxel	Paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Determination of the safety and tolerability of BBI503 administered in combination with selected anti-cancer therapeutics by assessing dose-limiting toxicities (DLTs)	3 or 4 weeks based on the cycle of the selected anti-cancer therapeutics
Determination of the Recommended Phase 2 Dose (RP2D) by assessing dose-limiting toxicities (DLTs)	3 or 4 weeks based on the cycle of the selected anti-cancer therapeutics

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profile of BBI503 administered in combination with selected anti-cancer therapeutics as assessed by maximum plasma concentration and area under the curve	0, 1, 2, 3, 4, 6, 8, 10, 24 hours on day 1, cycles 1 and 2
Pharmacodynamic activity of BBI503 administered in combination with selected anti-cancer therapeutics as assessed by biomarker analysis	3 or 4 weeks based on the cycle of the selected anti-cancer therapeutics	Histopathology and Cancer Stem Cell assays will be performed to provide information of the biomarkers on biopsied patient tumor tissue, and archival samples.
Assessment of the preliminary anti-tumor activity by performing tumor assessments every 8 weeks (Phase 2 portion)	6 months	Evaluation of anti-tumor activity will be performed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Trial Locations

Locations (8)

Parkview Research Center; 🇺🇸 Fort Wayne, Indiana, United States

Indiana University Health Goshen; 🇺🇸 Goshen, Indiana, United States

Indiana University -Ball; 🇺🇸 Indianapolis, Indiana, United States

Indiana University-SCC; 🇺🇸 Indianapolis, Indiana, United States

Louisiana State Univesity; 🇺🇸 New Orleans, Louisiana, United States

US Oncology Research; 🇺🇸 Fairfax, Virginia, United States

Ottawa Hospital Research Institute; 🇨🇦 Ottawa, Ontario, Canada

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada