A Phase 1/2a, Open Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of XER-001 (Amifostibe for Nasoduodenal Delivery) in Combination With Sterotactic Body Radiotherapy for Treatment of Locally-Advanced Pancreatic Adenocarcinoma
Xerient Pharma
Summary
The purpose of this study is to assess the safety, tolerability and efficacy of XER-001 and identify a best dose for future studies.
Description
The primary objective of the phase 1 component of the study is to evaluate the safety, tolerability, and PK of nasoduodenal administration of XER-001 in conjunction with stereotactic body radiotherapy (SBRT) in patients with LAPC. The primary objective of the phase 2a component of the study is to evaluate safety and efficacy of combination SBRT and XER-001 with increasingly-liberalized duodenal radiation dose constraints.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Cytologic or biopsy confirmed adenocarcinoma of the pancreas 2. Disease deemed amenable to definitive treatment with SBRT by being: 1. Locally-advanced and/or technically unresectable, as determined by a specialist pancreaticobiliary surgeon and as part of a multidisciplinary team review including of multiphase cross-sectional imaging, demonstrating: i. Greater than 180-degree tumor involvement of the superior mesenteric artery (SMA) ii. Greater than 180-degree tumor involvement of the celiac axis including major branches of the celiac axis that would render the tum…
Interventions
- DrugXER-001
XER-001 (Amifostine for nasoduodenal delivery)
Locations (4)
- City of HopeDuarte, California
- CIty of HopeIrvine, California
- Christus St. Vincent Regional Cancer CenterSanta Fe, New Mexico
- Oncology Consultants, P.A.Houston, Texas