A Phase IB Study of M3814 plus Capecitabine and Radiation Therapy for Patients with Locally Advanced Rectal Cancer

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Full Title

A Multicenter Study with an Open-label Phase Ib Part Followed by a Randomized, Placebo-controlled, Double-blind, Phase II Part to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of the DNA-PK Inhibitor M3814 in Combination with Capecitabine and Radiotherapy in Participants with Locally Advanced Rectal Cancer

Purpose

Capecitabine plus radiation therapy before surgery is a standard treatment for locally advanced rectal cancer. In this study, researchers want to find the highest dose of the investigational drug M3814 that can be given safely in combination with capecitabine and radiation therapy in patients with operable locally advanced rectal cancer that has not yet been treated. Patients who have an excellent response to therapy might be able to avoid surgery, allowing them to keep the rectum and anus intact.

M3814 blocks an enzyme called DNA-PK, which cancer cells use to repair the damage caused by radiation therapy. By inhibiting DNA-PK, M3814 could make rectal cancer cells more vulnerable to the anticancer effects of radiation and capecitabine. Both M3814 and capecitabine are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have locally advanced (stage III) operable rectal cancer that has not yet been treated.
  • Patients may not have had prior radiation therapy to the pelvis.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Paul Romesser at 646-888-2118.

Protocol

19-067

Phase

I/II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators