A Phase I/II Study of M3814 (Peposertib) in Combination with Hypofractionated Radiotherapy for the Treatment of Locally Advanced Pancreatic Adenocarcinoma
Details
This phase I/II trial studies the side effects and best dose of M3814 and to see how well it works when given together with radiation therapy in treating patients with pancreatic cancer that cannot be removed by surgery and has not spread to other parts of the body (localized). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving M3814 and hypofractionated radiation therapy together may work better than radiation therapy alone in the treatment of patients with localized pancreatic cancer.
Eligibility
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Inclusion Criteria:
Patients must have pathologically confirmed pancreatic adenocarcinoma.
Patients must have received 4-6 months of induction chemotherapy with either FOLFIRINOX or gemcitabine/abraxane, as per standard of care.
Patients must have locally advanced pancreatic cancer according to NCCN Guidelines on CT scan performed within 21 days of registration.
Exclusion Criteria:
Patients who have completed induction chemotherapy less than 2 weeks or more than 8 weeks prior to study enrollment.
Patients who are participating in other clinical trials and receiving any other investigational treatment.
Patients who have evidence of distant metastatic disease.
Patients who have had more than 1 line of chemotherapy for the treatment of localized pancreatic cancer.