Actively Recruiting
A Phase 1 Study to Evaluate Safety and Efficacy of XER-001 (Amifostine for Nasoduodenal Delivery) in Combination With Sterotactic Body Radiotherapy for Treatment in Patients With Locally Advanced Pancreatic Cancer.
Led by Xerient Pharma · Updated on 2026-05-01
36
Participants Needed
4
Research Sites
447 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the safety, tolerability and efficacy of XER-001 and identify a best dose for future studies.
CONDITIONS
Official Title
A Phase 1 Study to Evaluate Safety and Efficacy of XER-001 (Amifostine for Nasoduodenal Delivery) in Combination With Sterotactic Body Radiotherapy for Treatment in Patients With Locally Advanced Pancreatic Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cytologic or biopsy confirmed adenocarcinoma of the pancreas
- Disease suitable for SBRT, including locally advanced, unresectable, or anatomically resectable but not surgical candidate
- No distant metastatic disease before or after first-line systemic therapy
- Completion of medically indicated first-line systemic therapy (e.g., FOLFIRINOX, gemcitabine/abraxane)
- Age 18 years or older
- ECOG performance status 0, 1, or 2
- Adequate blood counts: neutrophils ≥1500/mm3, hemoglobin ≥8.0 g/dL, platelets ≥75,000/mm3
- Adequate liver function: bilirubin ≤1.5x upper limit normal, AST and ALT ≤2.5x upper limit normal
- Baseline serum calcium ≥8.4 mg/dL
- No significant abnormal ECG findings (normal sinus rhythm, QTcF ≤470 msec, QRS ≤110 msec, PRS ≤220 msec)
- Ability and willingness to comply with study procedures
- Written informed consent
- Women of childbearing potential must use effective contraception before and for 6 months after radiotherapy; men with partners of childbearing potential must use contraception during and for 3 months after radiotherapy
You will not qualify if you...
- Prior radiotherapy to upper abdomen overlapping planned SBRT field
- Prior radiopharmaceutical therapy
- Prior surgical removal of pancreatic tumor
- Active or uncontrolled gastric or duodenal ulcers within 30 days
- Visible tumor invasion into bowel or stomach lumen on endoscopy
- Ongoing grade 3 or higher non-hematological toxicity from chemotherapy
- Participation in another interventional trial or investigational agent use within 30 days
- Uncontrolled illnesses including active infection, heart failure, unstable angina, renal failure, or arrhythmias
- History of heart attack or unstable angina within 6 months
- History of severe hypocalcemia or hypoparathyroidism
- Unsafe hypertension management or low blood pressure at screening
- Liver or kidney disease affecting drug metabolism or assessments
- History of serious cardiac arrhythmias or electrical instability
- Medical conditions requiring treatment during study or likely to prevent study completion
- Inability to fast 3 hours before study drug administration
- Active hepatitis B/C or HIV without stable anti-retroviral therapy
- Blood donation or loss over 500 ml within 30 days
- Difficulty with venous access or unwillingness for catheter insertion
- Pregnant or breastfeeding women
- Study staff or immediate family members involved in study
- Investigator judgment of unsuitability or non-compliance risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
CIty of Hope
Irvine, California, United States, 92618
Actively Recruiting
3
Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico, United States, 87505
Actively Recruiting
4
Oncology Consultants, P.A.
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Robbin Frnka
CONTACT
J
Jeanne Jones
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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