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.

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 tumor unresectable (e.g. common hepatic artery) iii. Tumor involvement of the first branch of the SMA that is not surgically reconstructible iv. Long segment involvement of the superior mesenteric vein/portal vein/hepatic artery that is not amenable to surgical reconstructible.

2. Potentially resectable anatomically but deemed not a surgical candidate after multidisciplinary review (such as unresectable due to comorbid conditions that render.

the risks of surgery prohibitive)

3. Potentially resectable but the patient elects to refuse surgery and prefers to pursue SBRT, and disease is deemed eligible for SBRT

3. Primary tumor involvement abutment of the bowel is allowed, however bowel infiltration or invasion (identified endoscopically or by contrast enhanced imaging) is not allowed.

4. No distant metastatic disease either prior to or following induction systemic therapy

5. Completion of medically indicated first line systemic therapy, which may include but is not limited to regimens such as FOLFIRNOX, gemcitabine/abraxane, and similar regimens

6. Patients must be able to understand and comply with any treatment related procedures for SBRT. including breath-hold techniques or tolerance of compression belt, or other motion management strategies for SBRT delivery.

7. Age 18 years or older

8. Eastern Cooperative Group (ECOG) performance status 0, 1, or 2

9. Adequate hematologic function as indicated by:

1. Absolute neutrophil counts \>/= 1500/mm3

2. Hemaglobin \>/= 8.0 g/dL

3. Plor current use of hepato atelet count \>/= 75,000/mm3

10. No known liver disease or hepatic impairment, as well as no recent or current use of hepatotoxic drugs or substances that could compromise liver function unless a washout period has been completed. Adequate liver function as indicated by:

1. Total bilirubin \</= 1.5x upper limits of normal (per institutional laboratory reference standard)

2. Aspartate aminotransferase (AST) and alanine aminotranferase (ALT) \</= 2.5 upper limits of normal (per institutional reference standard)

11. Baseline serum calcium level \>/= 8.4 mg/dL

12. No clinically significant history or presence of safety 12-lead ECG findings as judged by the investigator at screening and check-in(s), including each criterion as listed below:

1. Normal sinus rhythm (heart rate between 40 and 100 bpm)

2. QTcF interval \</= 470 msec

3. QRS interval \</= 110 msec

4. and PRS interval \</= 220 msec Repeat measurements may be performed at the discretion of the investigator or designee

13. An understanding, ability, and willingness to fully comply with the protocol-defined schedule of assessments, procedures, and restrictions

14. Must provide written informed consent prior to the initiation of any protocol specific procedures

15. The effects of XER-001 on the developing human fetus are unknown. For this reason women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least six months following the last (fifth) day of radiotherapy on this study. Exceptions to this inclusion criterion are available to women who meet any of the following criteria:

* Postmenopausal (no menses in greater than or equal to 12 consecutive months or validated by follicle stimulating hormone \[FSH\] levels.

* History of hysterectomy or bilateral salpingo-oophorectomy

* Ovarian failure (FSH and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)

* History of bilateral tubal ligation or another surgical sterilization procedure

16. Approved methods of birth control are as follows: hormonal contraception (I.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal ligation or hysterectomy, subject/partner post vasectomy, implantable or injectable contraceptives, and condoms with spermacide. Not engaging in sexual activity through six months following the last (fifth) day of radiotherapy on this study is an acceptable practice; however periodic abstinence, the rhytm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

For male participants on this trial, contraception is required as above dusing the study and for at least three months following the last (fifth) day of radiotherapy on this study if the have partners who can become pregnant (woman of child-bearing potential). Similarly, male participants on this trial should not donate sperm during the study and for at lease three months following the last (fifth) day of radiotherapy on this study.

What this study is about