Locally Advanced Pancreatic Adenocarcinoma study: XER-001
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.
ClinicalTrials.gov ID: NCT07157033
What this study is testing
What is XER-001?
An investigational drug being studied as a potential treatment for locally advanced pancreatic adenocarcinoma. It is designed to protect normal tissues from radiation damage by acting as a radioprotective agent.
Also referred to as Amifostine.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether XER-001 is safe and how well it works when used with radiation for advanced pancreatic cancer.
- Who it's for
- You may be able to join if you have locally advanced pancreatic cancer and can receive radiation therapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Cytologic or biopsy confirmed adenocarcinoma of the pancreas
- Locally-advanced and/or technically unresectable, as determined by a specialist pancreaticobiliary surgeon and as part of a multidisciplinary team...
- Potentially resectable anatomically but deemed not a surgical candidate after multidisciplinary review (such as unresectable due to comorbid...
- Potentially resectable but the patient elects to refuse surgery and prefers to pursue SBRT, and disease is deemed eligible for SBRT
- Primary tumor involvement abutment of the bowel is allowed, however bowel infiltration or invasion (identified endoscopically or by contrast enhanced...
You likely can't join if
- Prior radiotherapy to the upper abdomen with overlap of. the anticipated SBRT field
- Prior radiopharmaceutical therapy
- Prior surgical resection of the pancreatic tumor
- Uncontrolled or active gastric or duodenal ulcer disease within 30 days of enrollment
- Visable invasion of tumor into the bowel/stomach.duodenal lumen on endoscopic evaluation
- Residual or ongoing grade 3+ non-hemotological toxicity from chemotherapy other than alopecia
See the full eligibility criteria
- Cytologic or biopsy confirmed adenocarcinoma of the pancreas
- 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...
- 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)
- Potentially resectable but the patient elects to refuse surgery and prefers to pursue SBRT, and disease is deemed eligible for SBRT
- Primary tumor involvement abutment of the bowel is allowed, however bowel infiltration or invasion (identified endoscopically or by contrast enhanced imaging) is not allowed.
- No distant metastatic disease either prior to or following induction systemic therapy
- 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
- 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.
- Age 18 years or older
- Eastern Cooperative Group (ECOG) performance status 0, 1, or 2
- Absolute neutrophil counts \>/= 1500/mm3
- Hemaglobin \>/= 8.0 g/dL
- Plor current use of hepato atelet count \>/= 75,000/mm3
- Total bilirubin \</= 1.5x upper limits of normal (per institutional laboratory reference standard)
- Aspartate aminotransferase (AST) and alanine aminotranferase (ALT) \</= 2.5 upper limits of normal (per institutional reference standard)
- Baseline serum calcium level \>/= 8.4 mg/dL
- Normal sinus rhythm (heart rate between 40 and 100 bpm)
- QTcF interval \</= 470 msec
- QRS interval \</= 110 msec
- and PRS interval \</= 220 msec Repeat measurements may be performed at the discretion of the investigator or designee
- An understanding, ability, and willingness to fully comply with the protocol-defined schedule of assessments, procedures, and restrictions
- Must provide written informed consent prior to the initiation of any protocol specific procedures
- 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
- 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...
- Prior radiotherapy to the upper abdomen with overlap of. the anticipated SBRT field
- Prior radiopharmaceutical therapy
- Prior surgical resection of the pancreatic tumor
- Uncontrolled or active gastric or duodenal ulcer disease within 30 days of enrollment
- Visable invasion of tumor into the bowel/stomach.duodenal lumen on endoscopic evaluation
- Residual or ongoing grade 3+ non-hemotological toxicity from chemotherapy other than alopecia
- Concurrent participation in another treatment clinical trial or use of another investigational agent within 30 days of study consent. Note that participation in non-treatment clinical trials (e.g.
- Uncontrolled intercurrent illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia
- Patients with history of myocardial infarction or unstable angina within 6 months prior to study enrollment
- Patients with history of symptomatic or (CTCAE-defined) grade 3+ hypocalcemia
- Patients with history of hypoparathyroidism
- Patients with history of hypertension where medical providers deem that interruption of antihypertensive regimen for one week is deemed unsafe.
- Patients with systolic blood pressure (BP) \< 100 or diastolic BP \< 65 at screening or baseline
- History or presence of a disease, such as hepatic impairment or renal insufficiency, that could affect the absorption, distribution, metabolism, or elimination of the investigational product, tolerance to radiotherapy...
- History of cardiac-related condition, which may include, but is not limited to, torsades de pointes, ventricular fibrillation, or ventricular tachycardia
- Presence or family history (parents and siblings) of congenital lqt syndrome or any premature history of myocardial infarction considered clinically significant by the investigator or designee
- History or presence of palpitations, unexplained syncope, shortness of breath or any other symptoms that may relate to cardiac arrhythmias
- Any ECG evidence of physiological variants predisposing to electrical instability (eg. frequent pre-ventricular systolic beats)
- Medical disorder that may require treatment during the study or make the subject unlikely to complete the study.
- Inability to fast for 3 hours prior to study drug administration
- Known history of active hepatitis B/C or active human immunodeficiency virus (HIV) not on highly-active anti-retroviral therapy for a minimum of 30 days
- Donation or loss of more than 500 ml of whole blood within 30 days prior to screening
- Difficulty with venous access or unstable or unwilling to undergo catheter insertion
- Female people who are currently pregnant (have a positive pregnancy test), are lactating, or planning to breastfeed.
- An employee of the sponsor or research site personnel directly affiliated with this study or their immediate family member defined as a spouse, parent, child, or sibling, whether biological or legally adopted
- A subject who, in the opinion of the investigator or designee, is considered unsuitable or unlikely to comply with the study protocol for any reason
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- Irvine, California, United States
- Detroit, Michigan, United States
- Santa Fe, New Mexico, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; Irvine, California, United States; Detroit, Michigan, United States; Santa Fe, New Mexico, United States; Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.