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JOURNAL ONKOLOGIE – STUDIE

A Study of Debio 1143 (Xevinapant) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy

Rekrutierend

NCT-Nummer:
NCT04459715

Studienbeginn:
August 2020

Letztes Update:
02.06.2021

Wirkstoff:
Debio 1143, Cisplatin, Placebo

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Debiopharm International SA

Collaborator:
GORTEC (Head and Neck Oncology and Radiotherapy Group)

Kontakt

Studienlocations
(3 von 111)

Department of radiation oncology, University Hospital Essen
45122 Essen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum Jena - Klinik fuer Hals - Nasen und Ohrenheilkunde HNO
7747 Jena
(Thüringen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitatsklinikum Leipzig AoR, Klinik für Strahlentherapie
04103 Leipzig
(Sachsen)
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Universitaetsmedizin Mannheim UMM, Klinik fuer Hals-Nasen-Ohrenheilkunde Kopf- und Halschirurgie
68167 Mannheim
(Baden-Württemberg)
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Klinikum der Landeshauptstadt Stuttgart gKAöR
70174 Stuttgart
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
University of Arizona Cancer Center
85724 Tucson
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University of Colorado at Denver and Health Sciences Center
80045 Aurora
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Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
20007 Washington
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ASCLEPES Research Centers
34607 Weeki Wachee
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Columbus Regional Research Institute
31904 Columbus
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IACT Health, John B. Amos Cancer Center
31904 Columbus
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Inventa Center for Cancer Research At Fort Wayne Medical Oncology and Hematology
46804 Fort Wayne
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Ashland-Bellefonte Cancer Center
41101 Ashland
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Norton Cancer Institute, Louisville, Kentucky, Brownsboro Hospital Campus
40241 Louisville
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Dana-Farber Cancer Institute
02215 Boston
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University South Hospital
48109-9001 Ann Arbor
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Karmanos Cancer institute
48302 Detroit
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University of Missouri - Ellis Fischel Cancer Center
65212 Columbia
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Washington University School of Medicine
63110 Saint Louis
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Wake Forest University School of Medicine
27157 Winston-Salem
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University of Cincinnati Medical Center
45267 Cincinnati
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Providence Portland Medical Center
97213 Portland
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Gettysburg Cancer Center
17325 Gettysburg
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Fox Chase Cancer Center
19111 Philadelphia
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Medical University of South Carolina- Hollings Cancer Center
29425 Charleston
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84106 Salt Lake City
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Hospital Aleman
1118 Buenos Aires
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1180 Buenos Aires
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2457 Santa Fe
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Ashford Cancer Centre Research, Tennyson Centre
5037 Adelaide
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03065 Fitzroy
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Peter MacCallum Cancer Centre
8006 Melbourne
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Princess Alexandra Hospital, Cancer Trials Unit
4102 Woolloongabba
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1200 Bruxelles
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2650 Edegem
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9000 Gent
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7100 La Louvière
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3000 Leuven
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CHU UCL Namur Site Sainte Elisabeth
5000 Namur
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Liga Norte Riograndense Contra o Câncer, Avenida Miguel Castro
59062-000 Natal
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Hospital de Caridade de Ijui, Avenida David Jose Martins
98700-000 Ijuí
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Centro Gaúcho Integrado, Rua Costa
90110-270 Porto Alegre
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Hospital de Base de Sao Jose do Rio Preto, Av. Brigadeiro Faria Lima
15090-000 São José Do Rio Preto
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Fundação Pio XII- Hospital de Cancer de Barretos, Rua Antenor Duarte Vilela
14784-400 Barretos
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90050-170 Porto Alegre
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20231-050 Rio De Janeiro
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09060-650 Santo André
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01246-000 São Paulo
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Oswaldo Cruz German Hospital
01323-020 São Paulo
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London Regional Cancer Program, London Health Sciences Centre
N6A 5W9 London
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CHU de Quebec-Université Laval
G1R 2J6 Québec
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50005 Hradec Králové
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70852 Ostrava-Poruba
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76001 Zlín
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6000 Batumi
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4600 Kutaisi
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Academician Fridon Todua Medical Center-Ltd Research Institute of Clinical Medicine
0112 Tbilisi
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0159 Tbilisi
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Simon Khechinashvili University Clinic
0179 Tbilisi
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LEPL First University Clinic of Tbilisi State Medical University
141 Tbilisi
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Agioi Anargiroi General Oncology Hospital of Kifissia
14564 Athens
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Theagenio Anticancer Hospital
54007 Thessaloníki
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1122 Budapest
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1145 Budapest
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9024 Győr
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724 Pécs
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6720 Szeged
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49241 Busan
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National Cancer Center Hematologic Oncology
10408 Goyang-si
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Seoul National University Bundang Hospital
13620 Seongnam
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KonKuk University Medical Center
0503 Seoul
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Korea University Anam Hospital
2841 Seoul
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Asan Medical Center, Asian Cacer Center
5505 Seoul
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Seoul National University Boramae Medical Center
7061 Seoul
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Pusan National University Yangsan Hospital, Oncol & Hematology
50612 Yangsan
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Uniwersyteckie Centrum Kliniczne - Klinika Onkologii i Radioterapii
80-214 Gdańsk
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Szpitale Pomorskie Sp. z o.o.
81-519 Gdynia
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Centrum Onkologii- Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach
44-102 Gliwice
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10-228 Olsztyn
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97-200 Łódź
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4710-243 Braga
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4434-502 Porto
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Hospital Pedro Hispano
4464- 513 Porto
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Republican clinical oncology dispensary
420074 Kazan
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Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I.Kryzhanovsky
660133 Krasnoyarsk
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Kursk Regional Clinical Oncology Dispensary
305524 Kursk
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EuroCityClinic
197022 Saint Petersburg
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Saint- Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)
197758 Saint Petersburg
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FSBI National Med Research Cancer Center N.N. Petrov
197758 Saint-Petersburg
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Republican Clinical Oncological Dispensary of Bashkortostan
450054 Ufa
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State Budgetary Institution of Healthcare of Yaroslavl region Clinical oncology hospital
150054 Yaroslavl
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Inselspital, Bern University Hospital, Universitätsklinik für Radio-Onkologie
3010 Bern
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Hopitaux Universitaires de Geneve
1205 Geneve
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Centre Hospitalier Universitaire Vaudois Lausanne
1011 Lausanne
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Kaohsiung Medical University Memorial Hospital
80756 Kaohsiung
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China Medical University Hospital
404472 Taichung
TaiwanNoch nicht rekrutierend» Google-Maps
National Taiwan University Hospital
10002 Taipei
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Taipei Veterans General Hospital (VGHTP)
11217 Taipei
TaiwanNoch nicht rekrutierend» Google-Maps
Medical center ASKLEPION LLC
8173 Khodosivka
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Kiev City Clinical Oncology Centre
3115 Kiev
UkraineNoch nicht rekrutierend» Google-Maps
Medical center of Yuriy Spizhenko, Soborna Vulytsia
8111 Kyiv
UkraineNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The primary objective of the study is to demonstrate superior efficacy of Debio 1143 vs

placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of

the head and neck (LA-SCCHN).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1

- Histologically confirmed diagnosis in previously untreated Locally Advanced Squamous

Cell Carcinoma of the Head and Neck (LA-SCCHN) participant (stage III, IVa or IVb

according to the American Joint Committee on Cancer(AJCC))/Classification of malignant

tumors: T=size of the primary tumor, N=regional lymph node involvement, M=distant

metastasis (TNM) Staging System, 8th Ed.) suitable for definitive ChemoRadiotherapy

(CRT), of at least one of the following sites: oropharynx, hypopharynx and larynx

- For OroPharyngeal Cancer (OPC) participants, primary tumors must be human

papillomavirus (HPV)-negative as determined by p16 expression using

immunohistochemistry

- Evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by

computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on

RECIST v 1.1

- Peripheral neuropathy < grade 2

- Adequate hematologic, renal and hepatic function

Exclusion Criteria:

- Primary tumor of nasopharyngeal, paranasal sinuses, nasal or oral cavity, salivary,

thyroid or parathyroid gland pathologies, skin or unknown primary site

- Metastatic disease (stage IVc as per AJCC/TNM, 8th Ed.)

- Prior definitive or adjuvant Radiotherapy (RT) and/or radical surgery to the head and

neck region which may jeopardize the primary tumor irradiation plan, or any other

prior SCCHN systemic treatment, including investigational agents

- Documented weight loss of >10% during the last 4 weeks prior to randomization (unless

adequate measures are undertaken for nutritional support), OR plasmatic albumin < 3.0

g/dL

- Known allergy to Debio 1143, cisplatin, carboplatin, other platinum-based agent or any

excipient known to be present in any of these products or in the placebo formulation.

Studien-Rationale

Primary outcome:

1. Event-Free Survival (EFS) (Time Frame - Up to 5 years):
EFS is the time from the date of randomization to the date of first record of disease progression or death.



Secondary outcome:

1. Progression-Free Survival (PFS) (Time Frame - Up to 5 years):
PFS is the time from randomization to the earliest between PFS event or End of Study (EOS)

2. Overall survival (OS) (Time Frame - Up to 5 years):
OS is the time from randomization to death due to any cause.

3. Locoregional Control (LRC) (Time Frame - From randomization to the earliest between PFS event (progression at the site of the primary tumor or the locoregional lymph nodes) or EOS (Up to 5 years))

4. Safety and Tolerability as assessed by incidence and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Changes in Laboratory Values, Vital Signs, Electrocardiogram (ECGs) and Extent of Exposure (Time Frame - From signed informed consent to EOS (within 6.8 years))

5. Changes from Baseline in Global Health Status/Quality of Life (GHS/QoL) and Fatigue Symptom (Time Frame - Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)):
Change from baseline in GHS/QoL and Fatigue Symptom using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30)

6. Changes from Baseline in Swallowing and Pain Symptoms (Time Frame - Prior to the first dose of study treatment (Baseline) and at the time of last follow-up (Up to 5 years)):
Change from baseline in swallowing, and pain symptoms using the EORTC Head and Neck Questionnaire (EORTC QLQ-H&N35)

Studien-Arme

  • Experimental: Debio 1143
    Participants will receive: Concomitant chemo-radiation therapy period (Cycles 1-3): Radiotherapy Cisplatin Debio 1143 Monotherapy period (Cycles 4-6): • Debio 1143
  • Active Comparator: Placebo
    Participants will receive: Concomitant chemo-radiation therapy period (Cycles 1-3): Radiotherapy Cisplatin Matched placebo Monotherapy period (Cycles 4-6): • Matched placebo

Geprüfte Regime

  • Debio 1143 (xevinapant):
    Debio 1143 administrated as oral solution from Day 1 to 14, every 21-day cycle.
  • Cisplatin:
    Cisplatin administered as an IV infusion every 3 weeks (Q3W).
  • Intensity Modulation Radiation Therapy (IMRT):
    70 Gy given in 35 fractions over 7 weeks
  • Placebo:
    Matched placebo administrated as oral solution from Day 1 to 14, every 21-day cycle.

Quelle: ClinicalTrials.gov


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