A Phase 1/2 Study of M3814 (Peposertib) in Combination with Hypofractionated Radiotherapy for the Treatment of Locally Advanced Pancreatic Adenocarcinoma

Clinical Trial Details

The purpose of this study is to test the safety of a drug called M3814 (peposertib) in combination with a specific type of radiation therapy (hypofractionated radiation) in patients with locally advanced pancreatic cancer. This study will test different doses of M3814 to see which dose is safer for people when combined with hypofractionated radiation.

M3814 (peposertib) is not yet approved by the U.S. Food and Drug Administration (FDA). Hypofractionated radiation is approved by the FDA, but not in combination with M3814. Medication is not usually given to patients receiving radiation who are not in a study.

Participants will receive M3814 (peposertib) along with hypofractionated radiation therapy over a 14-day period. M3814 (peposertib) will be given by mouth once a day for 14 days. Radiotherapy will be given 5 times, approximately every other day during this 14-day period, excluding weekends.

Study participation will last as long as the treatment is effective or participants want to continue in the study.

Key Eligibility:

Open to men and women, aged 18 and older, who have confirmed pancreatic adenocarcinoma.
Participants must not be pregnant and must be willing to use an adequate method of contraception.
Participants must not have a history of anaphylactic reaction to iodinated IV contrast required for radiation simulation.

Detailed eligibility will be reviewed when you contact the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Carina Puello, RN
(646) 962-3541
cap4008@med.cornell.edu

Primary Investigator(s)

Allyson J Ocean, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2110024077

ClinicalTrials.gov:

NCT04172532

Status

Open to Enrollment

Age Group

Adult

Disease

Pancreatic Cancer