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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

March 20, 2019

Primary Completion Date

June 21, 2021

Study Completion Date

February 21, 2022

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.

Trial Locations (14)

10042

Northwell Health, Inc, Great Neck

10065

Memorial Sloan-Kettering Cancer Center (MSKCC) - New York, New York

10461

Montefiore Medical Center, The Bronx

29425

Med. Univ. of South Carolina, Charleston

29605

Greenville Hospital System University Medical Center (ITOR), Greenville

43210

Ohio State University Clinical Trials Management Office - Ohio State CTMO Parent, Columbus

43614

University of Toledo Medical Center - Hematology/Oncology, Toledo

77030

The University of Texas MD Anderson Cancer Center, Houston

80045

University of Colorado Cancer Center, Aurora

06520

Yale University - Pediatric Respiratory Medicine, New Haven

Unknown

Hospital Universitari Vall d'Hebron - Dept of Oncology, Barcelona

Hospital Universitario 12 de Octubre - Servicio de Oncologia, Madrid

Hospital Regional Universitario de Malaga, Málaga

Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica, Valencia

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY

NCT03770689 - Study of Peposertib in Combination With Capecitabine and RT in Rectal Cancer | Biotech Hunter | Biotech Hunter