Study of Peposertib in Combination With Capecitabine and RT in Rectal Cancer

ClinicalTrials.gov ID: NCT03770689

Public ClinicalTrials.gov record NCT03770689. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 2:02 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official 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 Peposertib (M3814) in Combination With Capecitabine and RT in Participants With Locally Advanced Rectal Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The main purpose of the study was to define maximum tolerated dose (MTD), recommended Phase II dose (RP2D) safety and tolerability of Peposertib in combination with capecitabine and radiotherapy (RT).

Study identification

NCT ID: NCT03770689
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: EMD Serono Research & Development Institute, Inc.; Industry
Enrollment: 19 participants

Conditions and interventions

Conditions

Locally Advanced Rectal Cancer

Interventions

Drug · Radiation

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 19, 2019
Primary completion: Jun 20, 2021
Completion: Feb 20, 2022
Last update posted: Mar 20, 2023

2019 – 2022

United States locations

U.S. sites: 10
U.S. states: 6
U.S. cities: 10

Facility	City	State	ZIP	Site status
University of Colorado Cancer Center	Aurora	Colorado	80045	—
Yale University - Pediatric Respiratory Medicine	New Haven	Connecticut	06520	—
Northwell Health, Inc	Great Neck	New York	10042	—
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York	New York	New York	10065	—
Montefiore Medical Center	The Bronx	New York	10461	—
Ohio State University Clinical Trials Management Office - Ohio State CTMO Parent	Columbus	Ohio	43210	—
University of Toledo Medical Center - Hematology/Oncology	Toledo	Ohio	43614	—
Med. Univ. of South Carolina	Charleston	South Carolina	29425	—
Greenville Hospital System University Medical Center (ITOR)	Greenville	South Carolina	29605	—
The University of Texas MD Anderson Cancer Center	Houston	Texas	77030	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03770689, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 20, 2023 · Synced Sep 2, 2026

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The complete protocol, eligibility criteria, and contact information for NCT03770689 live on ClinicalTrials.gov.

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