At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Peposertib 50 mg, Peposertib 100 mg, and 4 other interventions for Locally Advanced Rectal Cancer. Completed, enrolled 19 participants across 14 sites in 2 countries.
Detailed 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).
Study Details
Timeline
Interventions
Participants received peposertib 50 milligram (mg) once daily 5 days per week up to 5.5 weeks.
Participants received peposertib 100 mg once daily 5 days per week up to 5.5 weeks.
Participants received peposertib 150 mg once daily 5 days per week up to 5.5 weeks.
Participants received peposertib 250 mg once daily 5 days per week up to 5.5 weeks.
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.
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.