NCT03770689

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
DRUG	Peposertib 50 mg	Participants received peposertib 50 milligram (mg) once daily 5 days per week up to 5.5 weeks.
DRUG	Peposertib 100 mg	Participants received peposertib 100 mg once daily 5 days per week up to 5.5 weeks.
DRUG	Peposertib 150 mg	Participants received peposertib 150 mg once daily 5 days per week up to 5.5 weeks.
DRUG	Peposertib 250 mg	Participants received peposertib 250 mg once daily 5 days per week up to 5.5 weeks.
DRUG	Capecitabine	Participants received capecitabine at a dose of 825 milligram per square meter (mg/m\^2) twice daily 5 days per week up to 5.5 weeks.
RADIATION	Radiotherapy (RT)	Participants received RT 50 to 50.4 Gray (Gy) to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks.

Timeline

• Start date: 2019-03-20
• Primary completion: 2021-06-21
• Completion: 2022-02-21
• First posted: 2018-12-10
• Last updated: 2023-03-21
• Results posted: 2022-07-07

Locations

14 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study