Тестирование добавления M3814 (пепосертиб) к лучевой терапии для пациентов с распространенным раком головы и шеи, которые не могут принимать цисплатин
Испытание фазы I с расширенной когортой ингибирования ДНК-ПК и IMRT у пациентов, не подходящих для лечения цисплатином, с местно-регионарно распространенным плоскоклеточным раком головы и шеи (HNSCC) на стадии 3-4
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.
Обзор исследования
Статус
Условия
- Клиническая стадия III, опосредованная ВПЧ (p16-положительная) карцинома ротоглотки AJCC v8
- Гипофарингеальная карцинома III стадии AJCC v8
- Рак гортани III стадии AJCC v8
- Стадия III рака губы и полости рта AJCC v8
- Стадия III Орофарингеальная (p16-отрицательная) карцинома AJCC v8
- Стадия IVA Рак губ и полости рта AJCC v8
- Продвинутая плоскоклеточная карцинома головы и шеи
- Стадия IVA Гипофарингеальная карцинома AJCC v8
- Стадия IVA Рак гортани AJCC v8
- Стадия IVA Орофарингеальная (p16-отрицательная) карцинома AJCC v8
- Стадия IVB Гипофарингеальная карцинома AJCC v8
- Рак гортани стадии IVB AJCC v8
- Стадия IVB Орофарингеальная (p16-отрицательная) карцинома AJCC v8
- Стадия IVB Рак губ и полости рта AJCC v8
- Продвинутая плоскоклеточная карцинома гортаноглотки
- Продвинутая плоскоклеточная карцинома гортани
- Распространенный плоскоклеточный рак полости рта
- Распространенный плоскоклеточный рак ротоглотки
Вмешательство/лечение
Подробное описание
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.
Dose Level -1:
Beginning 60-90 minutes before each radiation treatment, patients receive oral peposertib 50 mg once daily and undergo IMRT 70 Gy in 35 fractions over 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.
Dose Level 1:
Beginning 60-90 minutes before each radiation treatment, patients receive oral peposertib 100 mg once daily and undergo IMRT 70 Gy in 35 fractions over 7 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, or receive 18F-FDG IV and undergo PET/CT during screening and follow-up.
Dose Level 2:
Beginning 60-90 minutes before each radiation treatment, patients receive oral peposertib 150 mg once daily and undergo IMRT 70 Gy in 35 fractions over 7 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, or receive 18F-FDG IV and undergo PET/CT during screening and follow-up.
Dose Level 3:
Beginning 60-90 minutes before each radiation treatment, patients receive oral peposertib 200 mg once daily and undergo IMRT 70 Gy in 35 fractions over 7 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, or receive 18F-FDG IV and undergo PET/CT during screening and follow-up.
Dose Level 4:
Beginning 60-90 minutes before each radiation treatment, patients receive oral peposertib 250 mg once daily and undergo IMRT 70 Gy in 35 fractions over 7 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, or receive 18F-FDG IV and undergo PET/CT during screening and follow-up.
After completion of treatment, patients are followed up every 3 months for 2 years.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 1
Контакты и местонахождение
Места учебы
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Arizona
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Gilbert, Arizona, Соединенные Штаты, 85234
- Banner MD Anderson Cancer Center
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Phoenix, Arizona, Соединенные Штаты, 85054
- Mayo Clinic Hospital in Arizona
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Tucson, Arizona, Соединенные Штаты, 85719
- Banner University Medical Center - Tucson
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Tucson, Arizona, Соединенные Штаты, 85719
- University of Arizona Cancer Center-North Campus
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California
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La Jolla, California, Соединенные Штаты, 92093
- UC San Diego Moores Cancer Center
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Palo Alto, California, Соединенные Штаты, 94304
- Stanford Cancer Institute Palo Alto
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Florida
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Miami, Florida, Соединенные Штаты, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Tampa, Florida, Соединенные Штаты, 33612
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, Соединенные Штаты, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, Соединенные Штаты, 30322
- Emory University Hospital/Winship Cancer Institute
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Illinois
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Danville, Illinois, Соединенные Штаты, 61832
- Carle at The Riverfront
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Effingham, Illinois, Соединенные Штаты, 62401
- Carle Physician Group-Effingham
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Mattoon, Illinois, Соединенные Штаты, 61938
- Carle Physician Group-Mattoon/Charleston
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Urbana, Illinois, Соединенные Штаты, 61801
- Carle Cancer Center
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Kentucky
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Louisville, Kentucky, Соединенные Штаты, 40202
- The James Graham Brown Cancer Center at University of Louisville
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New York
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Mineola, New York, Соединенные Штаты, 11501
- NYU Langone Hospital - Long Island
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New York, New York, Соединенные Штаты, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
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Rochester, New York, Соединенные Штаты, 14642
- University of Rochester
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Rochester, New York, Соединенные Штаты, 14620
- Highland Hospital
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Ohio
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Columbus, Ohio, Соединенные Штаты, 43210
- Ohio State University Comprehensive Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, Соединенные Штаты, 73104
- University of Oklahoma Health Sciences Center
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Oregon
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Portland, Oregon, Соединенные Штаты, 97213
- Providence Portland Medical Center
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South Carolina
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Charleston, South Carolina, Соединенные Штаты, 29425
- Medical University of South Carolina
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South Dakota
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Sioux Falls, South Dakota, Соединенные Штаты, 57117-5134
- Sanford USD Medical Center - Sioux Falls
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Sioux Falls, South Dakota, Соединенные Штаты, 57104
- Sanford Cancer Center Oncology Clinic
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Texas
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Houston, Texas, Соединенные Штаты, 77030
- UT MD Anderson Cancer Center
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Virginia
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Fairfax, Virginia, Соединенные Штаты, 22031
- Inova Schar Cancer Institute
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
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Pathologically (histologically) proven diagnosis of HNSCC of the oral cavity, oropharynx, larynx, or hypopharynx prior to registration;
- Patients with oropharynx cancer need p16 determination by immunohistochemistry (where positive is defined as greater than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells), Note: Institutions must screen patients using a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. A rigorous laboratory accreditation process similar to the United States (U.S.) CLIA certification, such as the provincial accreditation status offered by the Ontario Laboratory Accreditation (OLA) Program in Canada, the College of American Pathologists (CAP), or an equivalent accreditation in other countries, is acceptable. The p16 results must be reported on the pathology report being submitted;
- Oral cavity, larynx, hypopharynx, or p16-negative oropharynx cancer must be stages T1-2N2-3 or T3N1-3 or T4N0-3 (American Joint Committee on Cancer [AJCC] version 8);
- p16-positive oropharynx cancer patients, stages T4N0-3 or T1-3N2-3 (AJCC version 8);
- The patient has measurable disease as defined by the presence of at least one measurable lesion per RECIST 1.1;
- Please note: A histological or pathological specimen from cervical lymph nodes with well-defined primary site documented clinically or radiologically is acceptable
-
Clinical stage noted above should be based upon following diagnostic workup:
- History/physical examination within 30 days prior to registration;
- Examination by radiation oncologist or medical oncologist or otolaryngology (ENT) or head & neck surgeon 30 days prior to registration, including fiber optic exam with laryngopharyngoscopy;
- Diagnostic quality computed tomography (CT) or magnetic resonance imaging (MRI) of neck, with contrast, within 30 days prior to registration. Fludeoxyglucose F-18 (18F-FDG) whole body positron emission tomography (PET)-CT scan within 42 days of registration is strongly recommended but does not replace the CT or MRI study. Note: If CT component of the PET/CT is of diagnostic quality then PET/CT can be used for eligibility, however the PET/CT scan must be done within 30 days prior to registration
- Diagnostic quality, cross sectional imaging of the thorax within 42 days prior to registration; 18-F-FDG-PET/CT or conventional CT are acceptable
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Age >= 18 years
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Patients must have a contraindication to cisplatin as defined in the following bullet points. Sites must complete the online tool at comogram.org prior to registration to determine if the patient is eligible. The scores must be recorded on a case report form (CRF). (Refer to data submission table on the NRG-HN008 protocol page on the NRG website);
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Age >= 70 with moderate to severe comorbidity, defined as having one or more of the following conditions within 30 days prior to registration;
- Modified Charlson Comorbidity Index >= 1
- Adult Comorbidity Evaluation (ACE)-27 Index >= 1
- Omega score < 0.80
- G-8 score =< 14
- Cancer and Aging Research Group (CARG) Toxicity Score >= 30%
- Cumulative Illness Rating Scale for Geriatrics (CIRS-G) Score >= 4 OR
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Age < 70 with severe comorbidity, defined as having two or more of the following conditions within 30 days prior to registration;
- Modified Charlson Comorbidity Index >= 1
- ACE-27 Index >= 1
- Omega score < 0.80
- G-8 score =< 14
- CARG Toxicity Score >= 30%
- CIRS-G Score >= 4 OR
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Age >= 18 with an absolute or relative contraindication to cisplatin, defined as one or more of the following criterion within 30 days prior to registration:
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Pre-existing peripheral neuropathy grade >= 1;
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Creatinine clearance (CrCl) must be > 30 and < 60 mL/min
- For this calculation, use the Cockcroft-Gault formula
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History of hearing loss, defined as either:
- Existing need of a hearing aid OR
- >= 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated
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Zubrod Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 30 days prior to registration
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Whole blood cell (WBC) >= 2000 cells/mm^3 (within 30 days prior to registration)
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Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 30 days prior to registration)
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Platelets >= 100,000 cells/mm^3 (within 30 days prior to registration)
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Hemoglobin >= 9.0 g/dL (within 30 days prior to registration); Note: The use of transfusion is acceptable
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Creatinine clearance (CrCl) > 30 mL/min (within 30 days prior to registration)
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Total bilirubin =< 1.5 x upper limit of normal (ULN) (except patients with Gilbert syndrome who can have total bilirubin < 3.0 mg/dL) (within 30 days prior to registration)
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Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN (within 30 days prior to registration)
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For women of child bearing potential (e.g. uterus present and menstruating), a negative serum pregnancy test within 14 days prior to registration. Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL
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The patient must provide study-specific informed consent prior to study entry
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Known human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and CD4 T cell count >= 200 are eligible for this trial. Testing is not required for entry into protocol
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Patients with a history of hepatitis B or C infection are eligible if they have an undetectable viral load
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Willing to use highly effective contraceptives for males and females of childbearing potential during therapy and for 12 weeks after the last dose of M3814 (peposertib); this inclusion is necessary because the treatment in this study may be significantly teratogenic
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Patients must be able to swallow whole tablets
Exclusion Criteria:
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Definitive clinical or radiologic evidence of distant (beyond cervical lymph node and neck tissue) metastatic disease
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Carcinoma of the neck of unknown primary site origin
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Patients with oral cavity cancer are excluded from participation if the patient is medically operable and the resection of the primary tumor is considered technically feasible by an oral or head and neck cancer surgical subspecialist
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Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease
- Note: Patients with RECIST, version (v.) 1.1 evaluable remaining cancer either in the neck or primary site remain eligible
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Prior invasive malignancy (except non-melanomatous skin cancer carcinoma, in situ of the breast, oral cavity, or cervix, low or very low-risk prostate cancer) unless disease free for a minimum of 3 years
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Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if not within =< 3 years
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Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
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Severe, active co-morbidity defined as follows:
- History of bone marrow transplant and organ transplant, including allogenic stem cell transplantation;
- Unstable angina requiring hospitalization in the last 6 months;
- New York Heart Association Functional classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.);
- Myocardial infarction within the last 6 months;
- Persistent grade 3-4 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) electrolyte abnormalities that cannot be reversed despite as indicated by repeat testing;
- Ongoing active infection that is associated with symptoms and/or requires antibiotic therapy at the time of registration (excluding asymptomatic bacteriuria, genital herpes, oral herpes, thrush, bacterial vaginosis, vaginal candidiasis, topical antifungals)
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Pregnancy and nursing females, if applicable
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Concomitant use of proton pump inhibitors (or unable to stop 5 days prior to treatment)
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Receipt of live vaccinations within 28 days prior to registration
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Patients unable to discontinue medications or substances that are:
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Strong inhibitors, inducers or sensitive substrates of CYP3A4/5, CYP2C19, or CYP2C9 prior to study treatment;
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Substrates of CYP1A2, CYP2B6, or CYP3A4/5 with a narrow therapeutic prior to study treatment;
- Note: Opioids are allowed, with the exception of methadone
-
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Fridericia's correction formula (QTcF) > 450 ms for males and > 470 ms for females
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Peposertib 100 mg + IMRT (DL1)
Beginning 60-90 minutes before each radiation treatment, patients receive oral peposertib 100 mg once daily and undergo IMRT 70 Gy in 35 fractions over 7 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, or receive 18F-FDG IV and undergo PET/CT during screening and follow-up. |
Undergo IMRT
Другие имена:
Given PO
Другие имена:
|
|
Экспериментальный: Peposertib 150 mg + IMRT (DL2)
Beginning 60-90 minutes before each radiation treatment, patients receive oral peposertib 150 mg once daily and undergo IMRT 70 Gy in 35 fractions over 7 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, or receive 18F-FDG IV and undergo PET/CT during screening and follow-up. |
Undergo IMRT
Другие имена:
Given PO
Другие имена:
|
|
Экспериментальный: Peposertib 200 mg + IMRT (DL3)
Beginning 60-90 minutes before each radiation treatment, patients receive oral peposertib 200 mg once daily and undergo IMRT 70 Gy in 35 fractions over 7 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, or receive 18F-FDG IV and undergo PET/CT during screening and follow-up. |
Undergo IMRT
Другие имена:
Given PO
Другие имена:
|
|
Экспериментальный: Peposertib 250 mg + IMRT (DL4)
Beginning 60-90 minutes before each radiation treatment, patients receive oral peposertib 250 mg once daily and undergo IMRT 70 Gy in 35 fractions over 7 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, or receive 18F-FDG IV and undergo PET/CT during screening and follow-up. |
Undergo IMRT
Другие имена:
Given PO
Другие имена:
|
|
Экспериментальный: Peposertib 50mg + IMRT (DL -1)
Beginning 60-90 minutes before each radiation treatment, patients receive oral peposertib 50 mg once daily and undergo IMRT 70 Gy in 35 fractions over 7 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, or receive 18F-FDG IV and undergo PET/CT during screening and follow-up. |
Undergo IMRT
Другие имена:
Given PO
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of participants who experienced Dose-limiting toxicities (DLTs)
Временное ограничение: From start of treatment through 4 weeks after completion of radiotherapy (approximately 11 weeks)
|
DLT was defined as any Grade 3 or higher adverse event definitely or probably related to peposertib or radiotherapy, excluding Grade 3 mucositis, Grade 3 radiation dermatitis, isolated Grade 3-4 asymptomatic lymphocytopenia, Grade 3 nausea or vomiting of <3 days duration with adequate therapy, Grade 3 fatigue, Grade 3 dysphagia, Grade 3 pain within the radiation field, Grade 3 asymptomatic amylase elevation, and other clinically insignificant laboratory abnormalities, or inability to complete at least 80% of the planned radiotherapy dose or radiotherapy delay >1 week due to adverse events definitely or probably related to peposertib. |
From start of treatment through 4 weeks after completion of radiotherapy (approximately 11 weeks)
|
|
Maximum tolerable dose (MTD)
Временное ограничение: From start of treatment through 4 weeks after completion of radiotherapy (approximately 11 weeks)
|
MTD was determined using a Bayesian Optimal Interval (BOIN) dose-escalation design based on the occurrence of dose-limiting toxicities (DLTs). |
From start of treatment through 4 weeks after completion of radiotherapy (approximately 11 weeks)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of Participants by Highest Grade Acute Adverse Event Reported
Временное ограничение: From start of treatment through 90 days after completion of radiotherapy (approximately 11 weeks)
|
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. |
From start of treatment through 90 days after completion of radiotherapy (approximately 11 weeks)
|
|
Number of Participants by Highest Grade Late Adverse Event Reported
Временное ограничение: From 91 days through 2 years after completion of radiotherapy (approximately 11 weeks)
|
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. |
From 91 days through 2 years after completion of radiotherapy (approximately 11 weeks)
|
|
Clinical response rate
Временное ограничение: 3 months after completion of IMRT (approximately 11 weeks)
|
Clinical response rate is defined as the proportion of participants achieving a complete or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. |
3 months after completion of IMRT (approximately 11 weeks)
|
|
6-Month and 1-Year Progression-free survival (PFS) rates at 6 months and one year
Временное ограничение: 6 months and 1 year after completion of IMRT
|
A PFS event was defined as locoregional failure, distant metastasis, or death due to any cause. Progressive disease was defined according to RECIST v1.1 criteria. PFS rates were estimated using the Kaplan-Meier method. Participants without a PFS event were censored at the date last known progression-free. Confidence intervals were calculated using a log-log transformation. |
6 months and 1 year after completion of IMRT
|
|
6-Month and 1-Year Overall survival (OS) rates
Временное ограничение: 6 months and 1 year after completion of IMRT (approximately 11 weeks)
|
Survival rates were estimated using the Kaplan-Meier method. Participants alive at last known follow-up were censored. Confidence intervals were calculated using a log-log transformation. |
6 months and 1 year after completion of IMRT (approximately 11 weeks)
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Pharmacokinetic (PK) parameter of M3814 (peposertib)
Временное ограничение: Within 30 minutes before administration, 2 hours and 4 hours after administration on day 1 of weeks 1 and 2
|
Plasma PK values will be estimated in the context of the Merck popPK model at the end of the trial and reported as such. PK-outcome relationships may be assessed in an exploratory fashion. |
Within 30 minutes before administration, 2 hours and 4 hours after administration on day 1 of weeks 1 and 2
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Maura L Gillison, NRG Oncology
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Заболевания полости рта
- Стоматогнатические заболевания
- Новообразования по локализации
- Новообразования
- Заболевания дыхательных путей
- Новообразования по гистологическому типу
- Новообразования головы и шеи
- Новообразования железистые и эпителиальные
- Новообразования дыхательных путей
- Оториноларингологические заболевания
- Новообразования глотки
- Оториноларингологические новообразования
- Заболевания глотки
- Заболевания гортани
- Карцинома
- Новообразования гортани
- Рот Новообразования
- Новообразования ротоглотки
- Гипофарингеальные новообразования
- Терапия
- Лучевая терапия
- Лучевая терапия, конформная
- Лучевая терапия, компьютерная помощь
- Лучевая терапия, модулированная интенсивностью
- Peposertib
Другие идентификационные номера исследования
- NCI-2020-06481
- U10CA180868 (Грант/контракт NIH США)
- NCI-2020-06481 (Идентификатор реестра: CTRP (Clinical Trial Reporting Program))
- NRG-HN008 (Другой идентификатор: CTEP)
- NRG-HN008 (Другой идентификатор: NRG Oncology)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .