Spots Global Cancer Trial Database for Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin
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Trial Identification
Brief Title: Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin
Official Title: Phase I Trial With Expansion Cohort of DNA-PK Inhibition and IMRT in Cisplatin-Ineligible Patients With Stage 3-4 Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Study ID: NCT04533750
Conditions
Study Description
Brief Summary: This phase I trial investigates the side effects and best dose of peposertib when given together with radiation therapy in treating patients with head and neck cancer that has spread to other places in the body (advanced) who cannot take cisplatin. Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This trial aims to see whether adding peposertib to radiation therapy is safe and works well in treating patients with head and neck cancer.
Detailed Description: PRIMARY OBJECTIVE: I. To determine the recommended phase 2 dose (RP2D) of M3814 (peposertib) when given in combination with intensity-modulated radiation therapy (IMRT). SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of the combination of M3814 (peposertib) with radiotherapy. II. To estimate the rates of grade 3 or greater acute toxicities of the regimen. III. To estimate late toxicities of the regimen. IV. To evaluate the clinical response rate, based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, at 3 months post completion of radiotherapy. V. To estimate 6 and 12-month progression-free survival (PFS) in the dose expansion cohort (DEC). VI. To estimate 6 and 12-month overall survival (OS) in the DEC. EXPLORATORY OBJECTIVE: I. To estimate the pharmacokinetic (PK) parameter of M3814 (peposertib) using population PK approaches. OUTLINE: This is a dose-escalation study of peposertib. Beginning 60-90 minutes before each radiation treatment, patients receive peposertib orally (PO) once daily (QD) and undergo IMRT daily Monday-Friday for 7 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT), magnetic resonance imaging (MRI), or receive fludeoxyglucose F-18 (18F-FDG) intravenously (IV) and undergo positron emission tomography (PET)/CT during screening and follow-up. After completion of treatment, patients are followed up every 3 months for 2 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
Banner University Medical Center - Tucson, Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Stanford Cancer Institute Palo Alto, Palo Alto, California, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory University Hospital Midtown, Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
Carle at The Riverfront, Danville, Illinois, United States
Carle Physician Group-Effingham, Effingham, Illinois, United States
Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
The James Graham Brown Cancer Center at University of Louisville, Louisville, Kentucky, United States
NYU Langone Hospital - Long Island, Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
Highland Hospital, Rochester, New York, United States
University of Rochester, Rochester, New York, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Providence Portland Medical Center, Portland, Oregon, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
M D Anderson Cancer Center, Houston, Texas, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
Contact Details
Name: Maura L Gillison
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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