A Study of BBI608 and BBI503 Administered in Combination to Adult Patients With Advanced Solid Tumors
- Registration Number
- NCT02432326
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief Summary
This is an open label, multi-center, phase 1 study of BBI608 and BBI503 administered orally in combination to patients with advanced solid tumors. The primary goal is to determine the safety, tolerability, and recommended phase II dose (RP2D) of the combination regimen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 147
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm A BBI608 - Arm A BBI503 -
- Primary Outcome Measures
Name Time Method Determination of the safety and tolerability of BBI608 and BBI503 when administered in combination by assessing dose-limiting toxicities (DLTs) 4 weeks Determination of the Recommended Phase 2 Dose of BBI608 and BBI503 when administered in combination based on DLT criteria, pharmacokinetic/pharmacodynamic observations and tolerability overall 20 weeks The overall tolerability assessment will include review of persistent grade 2 adverse events and review of adverse events occurring beyond the first cycle.
- Secondary Outcome Measures
Name Time Method Assessment of the preliminary anti-tumor activity by performing tumor assessments 16 weeks Pharmacokinetic profile of BBI608 and BBI503 when administered in combination as assessed by maximum plasma concentration and area under the curve. -5min, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hours on day 1, cycles 1 and 2 Pharmacodynamic activity assessed by tumor biopsy 4 weeks Tumor Biopsy to provide information on analysis of the effect of BBI608 and BBI503 on cancer stem cells through immunohistochemistry.
Trial Locations
- Locations (10)
Weill Cornell Medical College
🇺🇸New York, New York, United States
Texas Oncology - Tyler
🇺🇸Tyler, Texas, United States
Northwest Cancer Specialists, PC
🇺🇸Vancouver, Washington, United States
Texas Oncology - Fort Worth 12th Ave
🇺🇸Fort Worth, Texas, United States
Virginia Cancer Specialists, PC
🇺🇸Fairfax, Virginia, United States
University of Chicago Medicine Comprehensive Cancer Center
🇺🇸Chicago, Illinois, United States
Indiana University Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Texas Oncology, P.A.
🇺🇸San Antonio, Texas, United States
Texas Oncology - Austin Midtown
🇺🇸Austin, Texas, United States