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Test dell'aggiunta di M3814 (Peposertib) alla radioterapia per pazienti con carcinoma avanzato della testa e del collo che non possono assumere cisplatino

10 ottobre 2026 aggiornato da: National Cancer Institute (NCI)

Sperimentazione di fase I con coorte di espansione dell'inibizione DNA-PK e IMRT in pazienti non idonei al cisplatino con carcinoma a cellule squamose della testa e del collo avanzato localmente-regionale (HNSCC) in stadio 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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

Fase

Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: N / A
Modello interventistico: Assegnazione parallela
Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm Gruppo di partecipanti / Arm Un gruppo o sottogruppo di partecipanti a uno studio clinico che riceve un intervento/trattamento specifico o nessun intervento, secondo il protocollo dello studio.	Intervento / Trattamento Intervento / Trattamento Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Sperimentale: 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.	Radiazione: Intensity-Modulated Radiation Therapy Undergo IMRT Altri nomi: IMRT Intensità modulata RT Radioterapia a intensità modulata Radiazioni, radioterapia a modulazione di intensità Radioterapia a intensità modulata (procedura) Droga: Peposertib Given PO Altri nomi: MSC2490484A 3-piridazinametanolo, alfa-(2-cloro-4-fluoro-5-(7-(4-morfolinil)-4-chinazolinil)fenil)-6-metossi-, (alfaS)- M3814 M-3814 MSC 2490484A MSC-2490484A Nedisertib
Sperimentale: 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.	Radiazione: Intensity-Modulated Radiation Therapy Undergo IMRT Altri nomi: IMRT Intensità modulata RT Radioterapia a intensità modulata Radiazioni, radioterapia a modulazione di intensità Radioterapia a intensità modulata (procedura) Droga: Peposertib Given PO Altri nomi: MSC2490484A 3-piridazinametanolo, alfa-(2-cloro-4-fluoro-5-(7-(4-morfolinil)-4-chinazolinil)fenil)-6-metossi-, (alfaS)- M3814 M-3814 MSC 2490484A MSC-2490484A Nedisertib
Sperimentale: 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.	Radiazione: Intensity-Modulated Radiation Therapy Undergo IMRT Altri nomi: IMRT Intensità modulata RT Radioterapia a intensità modulata Radiazioni, radioterapia a modulazione di intensità Radioterapia a intensità modulata (procedura) Droga: Peposertib Given PO Altri nomi: MSC2490484A 3-piridazinametanolo, alfa-(2-cloro-4-fluoro-5-(7-(4-morfolinil)-4-chinazolinil)fenil)-6-metossi-, (alfaS)- M3814 M-3814 MSC 2490484A MSC-2490484A Nedisertib
Sperimentale: 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.	Radiazione: Intensity-Modulated Radiation Therapy Undergo IMRT Altri nomi: IMRT Intensità modulata RT Radioterapia a intensità modulata Radiazioni, radioterapia a modulazione di intensità Radioterapia a intensità modulata (procedura) Droga: Peposertib Given PO Altri nomi: MSC2490484A 3-piridazinametanolo, alfa-(2-cloro-4-fluoro-5-(7-(4-morfolinil)-4-chinazolinil)fenil)-6-metossi-, (alfaS)- M3814 M-3814 MSC 2490484A MSC-2490484A Nedisertib
Sperimentale: 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.	Radiazione: Intensity-Modulated Radiation Therapy Undergo IMRT Altri nomi: IMRT Intensità modulata RT Radioterapia a intensità modulata Radiazioni, radioterapia a modulazione di intensità Radioterapia a intensità modulata (procedura) Droga: Peposertib Given PO Altri nomi: MSC2490484A 3-piridazinametanolo, alfa-(2-cloro-4-fluoro-5-(7-(4-morfolinil)-4-chinazolinil)fenil)-6-metossi-, (alfaS)- M3814 M-3814 MSC 2490484A MSC-2490484A Nedisertib

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Number of participants who experienced Dose-limiting toxicities (DLTs) Lasso di tempo: 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) Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Number of Participants by Highest Grade Acute Adverse Event Reported Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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)

Altre misure di risultato

Misura del risultato	Misura Descrizione	Lasso di tempo
Pharmacokinetic (PK) parameter of M3814 (peposertib) Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Cancer Institute (NCI)

Collaboratori

NRG Oncology

Investigatori

Investigatore principale: Maura L Gillison, NRG Oncology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 dicembre 2021

Completamento primario (Effettivo)

7 dicembre 2025

Completamento dello studio (Stimato)

15 dicembre 2026

Date di iscrizione allo studio

Primo inviato

29 agosto 2020

Primo inviato che soddisfa i criteri di controllo qualità

29 agosto 2020

Primo Inserito (Effettivo)

1 settembre 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 ottobre 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

NCI-2020-06481
U10CA180868 (Sovvenzione/contratto NIH degli Stati Uniti)
NCI-2020-06481 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
NRG-HN008 (Altro identificatore: CTEP)
NRG-HN008 (Altro identificatore: NRG Oncology)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

prodotto fabbricato ed esportato dagli Stati Uniti

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Test dell'aggiunta di M3814 (Peposertib) alla radioterapia per pazienti con carcinoma avanzato della testa e del collo che non possono assumere cisplatino

Sperimentazione di fase I con coorte di espansione dell'inibizione DNA-PK e IMRT in pazienti non idonei al cisplatino con carcinoma a cellule squamose della testa e del collo avanzato localmente-regionale (HNSCC) in stadio 3-4

Panoramica dello studio

Stato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Tipo di studio

Iscrizione (Effettivo)

Fase

Contatti e Sedi

Luoghi di studio

Criteri di partecipazione

Criteri di ammissibilità

Età idonea allo studio

Accetta volontari sani

Sessi ammissibili allo studio

Descrizione

Piano di studio

Come è strutturato lo studio?

Dettagli di progettazione

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm

Intervento / Trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Misure di risultato secondarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Altre misure di risultato

Misura del risultato

Misura Descrizione

Lasso di tempo

Collaboratori e investigatori

Sponsor

Collaboratori

Investigatori

Studiare le date dei record

Studia le date principali

Inizio studio (Effettivo)

Completamento primario (Effettivo)

Completamento dello studio (Stimato)

Date di iscrizione allo studio

Primo inviato

Primo inviato che soddisfa i criteri di controllo qualità

Primo Inserito (Effettivo)

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo verificato

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

prodotto fabbricato ed esportato dagli Stati Uniti