A Study of BBI503 in Combination With Selected Anti-Cancer Therapeutics in Adult Patients With Advanced Cancer
- Conditions
- Cancer
- Interventions
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
Not provided
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)
Indiana University Health Goshen
🇺🇸Goshen, Indiana, United States
Louisiana State Univesity
🇺🇸New Orleans, Louisiana, United States
Ottawa Hospital Research Institute
🇨🇦Ottawa, Ontario, Canada
Parkview Research Center
🇺🇸Fort Wayne, Indiana, United States
Indiana University -Ball
🇺🇸Indianapolis, Indiana, United States
Indiana University-SCC
🇺🇸Indianapolis, Indiana, United States
US Oncology Research
🇺🇸Fairfax, Virginia, United States
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada