Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Testování přidání M3814 (Peposertib) k radioterapii u pacientů s pokročilou rakovinou hlavy a krku, kteří nemohou užívat cisplatinu

10. října 2026 aktualizováno: National Cancer Institute (NCI)

Studie fáze I s expanzní kohortou inhibice DNA-PK a IMRT u pacientů nezpůsobilých pro cisplatinu s lokálně-regionálně pokročilým spinocelulárním karcinomem hlavy a krku (HNSCC) stadia 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.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

Fáze

Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Spojené státy
- Arizona
  - Gilbert, Arizona, Spojené státy, 85234
    - Banner MD Anderson Cancer Center
  - Phoenix, Arizona, Spojené státy, 85054
    - Mayo Clinic Hospital in Arizona
  - Tucson, Arizona, Spojené státy, 85719
    - Banner University Medical Center - Tucson
  - Tucson, Arizona, Spojené státy, 85719
    - University of Arizona Cancer Center-North Campus
- California
  - La Jolla, California, Spojené státy, 92093
    - UC San Diego Moores Cancer Center
  - Palo Alto, California, Spojené státy, 94304
    - Stanford Cancer Institute Palo Alto
- Florida
  - Miami, Florida, Spojené státy, 33136
    - University of Miami Miller School of Medicine-Sylvester Cancer Center
  - Tampa, Florida, Spojené státy, 33612
    - Moffitt Cancer Center
- Georgia
  - Atlanta, Georgia, Spojené státy, 30308
    - Emory University Hospital Midtown
  - Atlanta, Georgia, Spojené státy, 30322
    - Emory University Hospital/Winship Cancer Institute
- Illinois
  - Danville, Illinois, Spojené státy, 61832
    - Carle at The Riverfront
  - Effingham, Illinois, Spojené státy, 62401
    - Carle Physician Group-Effingham
  - Mattoon, Illinois, Spojené státy, 61938
    - Carle Physician Group-Mattoon/Charleston
  - Urbana, Illinois, Spojené státy, 61801
    - Carle Cancer Center
- Kentucky
  - Louisville, Kentucky, Spojené státy, 40202
    - The James Graham Brown Cancer Center at University of Louisville
- New York
  - Mineola, New York, Spojené státy, 11501
    - NYU Langone Hospital - Long Island
  - New York, New York, Spojené státy, 10016
    - Laura and Isaac Perlmutter Cancer Center at NYU Langone
  - Rochester, New York, Spojené státy, 14642
    - University of Rochester
  - Rochester, New York, Spojené státy, 14620
    - Highland Hospital
- Ohio
  - Columbus, Ohio, Spojené státy, 43210
    - Ohio State University Comprehensive Cancer Center
- Oklahoma
  - Oklahoma City, Oklahoma, Spojené státy, 73104
    - University of Oklahoma Health Sciences Center
- Oregon
  - Portland, Oregon, Spojené státy, 97213
    - Providence Portland Medical Center
- South Carolina
  - Charleston, South Carolina, Spojené státy, 29425
    - Medical University of South Carolina
- South Dakota
  - Sioux Falls, South Dakota, Spojené státy, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, Spojené státy, 57104
    - Sanford Cancer Center Oncology Clinic
- Texas
  - Houston, Texas, Spojené státy, 77030
    - UT MD Anderson Cancer Center
- Virginia
  - Fairfax, Virginia, Spojené státy, 22031
    - Inova Schar Cancer Institute

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

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
Age >= 18 years
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);
- 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
- 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
- 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:
  - Pre-existing peripheral neuropathy grade >= 1;
  - Creatinine clearance (CrCl) must be > 30 and < 60 mL/min
    - For this calculation, use the Cockcroft-Gault formula
  - 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
Zubrod Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 30 days prior to registration
Whole blood cell (WBC) >= 2000 cells/mm^3 (within 30 days prior to registration)
Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 30 days prior to registration)
Platelets >= 100,000 cells/mm^3 (within 30 days prior to registration)
Hemoglobin >= 9.0 g/dL (within 30 days prior to registration); Note: The use of transfusion is acceptable
Creatinine clearance (CrCl) > 30 mL/min (within 30 days prior to registration)
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)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN (within 30 days prior to registration)
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
The patient must provide study-specific informed consent prior to study entry
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
Patients with a history of hepatitis B or C infection are eligible if they have an undetectable viral load
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
Patients must be able to swallow whole tablets

Exclusion Criteria:

Definitive clinical or radiologic evidence of distant (beyond cervical lymph node and neck tissue) metastatic disease
Carcinoma of the neck of unknown primary site origin
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
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
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
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if not within =< 3 years
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
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)
Pregnancy and nursing females, if applicable
Concomitant use of proton pump inhibitors (or unable to stop 5 days prior to treatment)
Receipt of live vaccinations within 28 days prior to registration
Patients unable to discontinue medications or substances that are:
- Strong inhibitors, inducers or sensitive substrates of CYP3A4/5, CYP2C19, or CYP2C9 prior to study treatment;
- Substrates of CYP1A2, CYP2B6, or CYP3A4/5 with a narrow therapeutic prior to study treatment;
  - Note: Opioids are allowed, with the exception of methadone
Fridericia's correction formula (QTcF) > 450 ms for males and > 470 ms for females

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Primární účel: Léčba
Přidělení: N/A
Intervenční model: Paralelní přiřazení
Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm Skupina účastníků / Arm Skupina nebo podskupina účastníků klinické studie, která podle protokolu studie dostává konkrétní intervenci/léčbu nebo žádnou intervenci.	Intervence / Léčba Intervence / Léčba Proces nebo akce, na které se klinická studie zaměřuje. Intervence zahrnují léky, zdravotnická zařízení, postupy, vakcíny a další produkty, které jsou buď zkoušené nebo již dostupné. Intervence mohou také zahrnovat neinvazivní přístupy, jako je edukace nebo úprava stravy a cvičení.
Experimentální: 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.	Záření: Intensity-Modulated Radiation Therapy Undergo IMRT Ostatní jména: IMRT Intensity Modulated RT Intenzivně modulovaná radioterapie Radiace, Intensivně modulovaná radioterapie Radiační terapie s modulovanou intenzitou (postup) Lék: Peposertib Given PO Ostatní jména: MSC2490484A 3-Pyridazinmethanol, alfa-(2-Chlor-4-fluor-5-(7-(4-morfolinyl)-4-chinazolinyl)fenyl)-6-methoxy-, (alfaS)- M 3814 M-3814 M3814 MSC 2490484A MSC-2490484A Nedisertib
Experimentální: 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.	Záření: Intensity-Modulated Radiation Therapy Undergo IMRT Ostatní jména: IMRT Intensity Modulated RT Intenzivně modulovaná radioterapie Radiace, Intensivně modulovaná radioterapie Radiační terapie s modulovanou intenzitou (postup) Lék: Peposertib Given PO Ostatní jména: MSC2490484A 3-Pyridazinmethanol, alfa-(2-Chlor-4-fluor-5-(7-(4-morfolinyl)-4-chinazolinyl)fenyl)-6-methoxy-, (alfaS)- M 3814 M-3814 M3814 MSC 2490484A MSC-2490484A Nedisertib
Experimentální: 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.	Záření: Intensity-Modulated Radiation Therapy Undergo IMRT Ostatní jména: IMRT Intensity Modulated RT Intenzivně modulovaná radioterapie Radiace, Intensivně modulovaná radioterapie Radiační terapie s modulovanou intenzitou (postup) Lék: Peposertib Given PO Ostatní jména: MSC2490484A 3-Pyridazinmethanol, alfa-(2-Chlor-4-fluor-5-(7-(4-morfolinyl)-4-chinazolinyl)fenyl)-6-methoxy-, (alfaS)- M 3814 M-3814 M3814 MSC 2490484A MSC-2490484A Nedisertib
Experimentální: 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.	Záření: Intensity-Modulated Radiation Therapy Undergo IMRT Ostatní jména: IMRT Intensity Modulated RT Intenzivně modulovaná radioterapie Radiace, Intensivně modulovaná radioterapie Radiační terapie s modulovanou intenzitou (postup) Lék: Peposertib Given PO Ostatní jména: MSC2490484A 3-Pyridazinmethanol, alfa-(2-Chlor-4-fluor-5-(7-(4-morfolinyl)-4-chinazolinyl)fenyl)-6-methoxy-, (alfaS)- M 3814 M-3814 M3814 MSC 2490484A MSC-2490484A Nedisertib
Experimentální: 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.	Záření: Intensity-Modulated Radiation Therapy Undergo IMRT Ostatní jména: IMRT Intensity Modulated RT Intenzivně modulovaná radioterapie Radiace, Intensivně modulovaná radioterapie Radiační terapie s modulovanou intenzitou (postup) Lék: Peposertib Given PO Ostatní jména: MSC2490484A 3-Pyridazinmethanol, alfa-(2-Chlor-4-fluor-5-(7-(4-morfolinyl)-4-chinazolinyl)fenyl)-6-methoxy-, (alfaS)- M 3814 M-3814 M3814 MSC 2490484A MSC-2490484A Nedisertib

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Number of participants who experienced Dose-limiting toxicities (DLTs) Časové okno: 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) Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Number of Participants by Highest Grade Acute Adverse Event Reported Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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)

Další výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Pharmacokinetic (PK) parameter of M3814 (peposertib) Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

National Cancer Institute (NCI)

Spolupracovníci

NRG Oncology

Vyšetřovatelé

Vrchní vyšetřovatel: Maura L Gillison, NRG Oncology

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

20. prosince 2021

Primární dokončení (Aktuální)

7. prosince 2025

Dokončení studie (Odhadovaný)

15. prosince 2026

Termíny zápisu do studia

První předloženo

29. srpna 2020

První předloženo, které splnilo kritéria kontroly kvality

29. srpna 2020

První zveřejněno (Aktuální)

1. září 2020

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. října 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. října 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

NCI-2020-06481
U10CA180868 (Grant/smlouva NIH USA)
NCI-2020-06481 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
NRG-HN008 (Jiný identifikátor: CTEP)
NRG-HN008 (Jiný identifikátor: NRG Oncology)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

produkt vyrobený a vyvážený z USA

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Testování přidání M3814 (Peposertib) k radioterapii u pacientů s pokročilou rakovinou hlavy a krku, kteří nemohou užívat cisplatinu

Studie fáze I s expanzní kohortou inhibice DNA-PK a IMRT u pacientů nezpůsobilých pro cisplatinu s lokálně-regionálně pokročilým spinocelulárním karcinomem hlavy a krku (HNSCC) stadia 3-4

Přehled studie

Postavení

Podmínky

Intervence / Léčba

Detailní popis

Typ studie

Zápis (Aktuální)

Fáze

Kontakty a umístění

Studijní místa

Kritéria účasti

Kritéria způsobilosti

Věk způsobilý ke studiu

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Popis

Studijní plán

Jak je studie koncipována?

Detaily designu

Počet zbraní

Zbraně a zásahy

Skupina účastníků / Arm

Intervence / Léčba

Co je měření studie?

Primární výstupní opatření

Měření výsledku

Popis opatření

Časové okno

Sekundární výstupní opatření

Měření výsledku

Popis opatření

Časové okno

Další výstupní opatření

Měření výsledku

Popis opatření

Časové okno

Spolupracovníci a vyšetřovatelé

Sponzor

Spolupracovníci

Vyšetřovatelé

Termíny studijních záznamů

Hlavní termíny studia

Začátek studia (Aktuální)

Primární dokončení (Aktuální)

Dokončení studie (Odhadovaný)

Termíny zápisu do studia

První předloženo

První předloženo, které splnilo kritéria kontroly kvality

První zveřejněno (Aktuální)

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

Naposledy ověřeno

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Popis plánu IPD

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Studuje produkt zařízení regulovaný americkým úřadem FDA

produkt vyrobený a vyvážený z USA