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

NCT03770689 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-03-21

Study results available
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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

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.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • EMD Serono Research & Development Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck KGaA, Darmstadt, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-20
Primary Completion
2021-06-21
Completion
2022-02-21
FDA Drug
Yes

Countries

  • United States
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03770689 on ClinicalTrials.gov