Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
4D pharma plc
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient has signed informed consent and is willing to comply with the protocol
Cytologic or biopsy confirmed adenocarcinoma of the pancreas
TNM stage: Tx, T1-4, N0-1 or Nx, M0
Potentially resectable pancreatic cancer defined as no extra-pancreatic disease, no evidence of tumor extension to the celiac axis, common hepatic artery and superior mesenteric artery, and no evidence of deformity of the superior mesenteric vein or superior mesenteric portal vein confluence
No evidence of distant metastases either prior to or after induction chemotherapy
Able to comply with instructions required for radiation therapy
Age 18 years or older
Completion of 2-6 months of standard induction chemotherapy (mFOLFIRINOX, gemcitabine and nab-paclitaxel or other)
Eastern Cooperative Oncology Group Score 0, 1 or 2
Adequate renal and liver function (creatinine ≤ 1.5 x upper limit of normal; total bilirubin ≤ 1.5 x upper limit of normal; aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal; alkaline phosphatase ≤ 2.5 x upper limit of normal
You may not be if
Prior radiation therapy to the abdomen that would overlap with the treatment field
Prior surgical resection of pancreatic tumor
Receiving any approved or investigational anti-cancer agent other than those provided for in this study
Uncontrolled or active gastric or duodenal ulcer disease within 30 days of dosing
Residual or ongoing ≥Grade 3 toxicity from chemotherapy
Contraindication to IV contrast that can't be managed with pre-medication
Concurrent participation in another interventional clinical trial or use of another investigational agent within 30 days of consent (concurrent non-interventional trials are eligible)
Uncontrolled intercurrent illness including but not limited to, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, stroke, or psychiatric illness that would limit compliance with treatment
Second primary malignancy within the last 5 years, unless treated definitively and/or low risk in the judgement of the treating investigator
Known history of HIV or active hepatitis B/C (patients who have been vaccinated for hepatitis B and do not have history of infection are eligible)
Known intolerance or hypersensitivity to study drug
Subjects who are allergic to amoxicillin/clavulanic acid, erythromycin and imipenem
Female subjects who are breastfeeding
Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control for the entire study and for 30 days after last dose of MRx0518. A negative pregnancy test must be obtained within 14 days prior to start of treatment
Male subjects who are unwilling or unable to use an acceptable method of birth control for the entire study period and for 30 days after last dose of MRx0518
Serious infection requiring systemic therapy
Use of systemic antibiotics within 2 weeks of start of study treatment
Has a known inability for intake of oral capsules
Clareo Health | A Study of Live Biotherapeutic Product MRx0518 With Hypofractionated Radiation Therapy in Resectable Pancreatic Cancer
