Study of Peposertib in Combination With Capecitabine and RT in Rectal Cancer
NCT ID: NCT03770689
Last Updated: 2023-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
19 participants
INTERVENTIONAL
2019-03-20
2022-02-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Peposertib 50 mg + RT + Capecitabine
Participants received peposertib 50 milligram (mg) once daily in combination with capecitabine 825 milligram per square meter (mg/m\^2) twice daily 5 days per week and radiotherapy (RT) of 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 treatment period.
Peposertib 50 mg
Participants received peposertib 50 milligram (mg) once daily 5 days per week up to 5.5 weeks.
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.
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.
Peposertib 100 mg + RT + Capecitabine
Participants received peposertib 100 mg once daily in combination with capecitabine 825 mg/m\^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period.
Peposertib 100 mg
Participants received peposertib 100 mg once daily 5 days per week up to 5.5 weeks.
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.
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.
Peposertib 150 mg + RT + Capecitabine
Participants received peposertib 150 mg once daily in combination with capecitabine 825 mg/m\^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period.
Peposertib 150 mg
Participants received peposertib 150 mg once daily 5 days per week up to 5.5 weeks.
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.
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.
Peposertib 250 mg + RT + Capecitabine
Participants received peposertib 250 mg once daily in combination with capecitabine 825 mg/m\^2 twice daily 5 days per week and RT of 50 to 50.4 Gy to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions up to 5.5 weeks treatment period.
Peposertib 250 mg
Participants received peposertib 250 mg once daily 5 days per week up to 5.5 weeks.
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.
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.
Interventions
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Peposertib 50 mg
Participants received peposertib 50 milligram (mg) once daily 5 days per week up to 5.5 weeks.
Peposertib 100 mg
Participants received peposertib 100 mg once daily 5 days per week up to 5.5 weeks.
Peposertib 150 mg
Participants received peposertib 150 mg once daily 5 days per week up to 5.5 weeks.
Peposertib 250 mg
Participants received peposertib 250 mg once daily 5 days per week up to 5.5 weeks.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants who have histologically confirmed and localized resectable rectal cancer (Stage 3)
* Participants who received induction chemotherapy are allowed to be enrolled to this study except this induction is resulting in clinical complete response (cCR) or tumor progression
* Participants who have lower edge of the tumor located in rectum
* Adequate hematological, hepatic and renal function as defined in the protocol
* Male participants if they agree to the following during the study intervention period and for at least 12 weeks after the last dose of study intervention
* Female participants are eligible if not pregnant or breastfeeding
Exclusion Criteria
* Participants with history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the study intervention
* Unstable cardiovascular function within 6 months prior to enrollment
* Hypertension uncontrolled by medication (ie, systolic blood pressure \>= 150 millimeter of mercury (mmHg) and diastolic blood pressure \>= 90 mmHg)
* Participants with history of other malignant disease within the past 5 years, other than successfully treated basal carcinoma of the skin or carcinoma in situ of the cervix
* Participants with known human immunodeficiency virus positivity, known active hepatitis (for example, hepatitis B virus or hepatitis C virus), current alcohol abuse, or cirrhosis
* Participants with ongoing active infection or treatment with a live attenuated vaccine within 4 weeks of dosing
* Participants with concomitant use of H2-blocker or proton pump inhibitors (PPIs) (or unable to stop at least 5 days prior to the first treatment). Note that calcium carbonate is acceptable
* Participation in any interventional clinical study within 28 days prior to Screening or during participation in this study
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
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University of Colorado Cancer Center
Aurora, Colorado, United States
Yale University - Pediatric Respiratory Medicine
New Haven, Connecticut, United States
Northwell Health, Inc
Great Neck, New York, United States
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Ohio State University Clinical Trials Management Office - Ohio State CTMO Parent
Columbus, Ohio, United States
University of Toledo Medical Center - Hematology/Oncology
Toledo, Ohio, United States
Med. Univ. of South Carolina
Charleston, South Carolina, United States
Greenville Hospital System University Medical Center (ITOR)
Greenville, South Carolina, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Hospital Universitari Vall d'Hebron - Dept of Oncology
Barcelona, , Spain
Hospital Universitario 12 de Octubre - Servicio de Oncologia
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica
Valencia, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Trial Awareness and Transparency website
US Medical Information website, Medical Resources
DDRiver website
Other Identifiers
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2018-002275-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MS100036_0020
Identifier Type: -
Identifier Source: org_study_id
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