JOURNAL ONKOLOGIE – STUDIE
A Study of Debio 1143 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:
31.12.2020
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
Kontakt:
Phone: +41 21 321 01 11
E-Mail: clinicaltrials@debiopharm.com» Kontaktdaten anzeigen
Studienlocations (3 von 42)
Department of radiation oncology, University Hospital Essen
45122 Essen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-MapsUniversitaetsmedizin Mannheim UMM, Klinik fuer Hals-Nasen-Ohrenheilkunde Kopf- und Halschirurgie
68167 Mannheim
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-MapsKlinikum der Landeshauptstadt Stuttgart gKAöR
70174 Stuttgart
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
45122 Essen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-MapsUniversitaetsmedizin Mannheim UMM, Klinik fuer Hals-Nasen-Ohrenheilkunde Kopf- und Halschirurgie
68167 Mannheim
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-MapsKlinikum der Landeshauptstadt Stuttgart gKAöR
70174 Stuttgart
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
ASCLEPES Research Centers
34607 Weeki Wachee
United StatesNoch nicht rekrutierend» Google-MapsColumbus Regional Research Institute
31904 Columbus
United StatesRekrutierend» Google-MapsIACT Health, John B. Amos Cancer Center
31904 Columbus
United StatesNoch nicht rekrutierend» Google-MapsInventa Center for Cancer Research At Fort Wayne Medical Oncology and Hematology
46804 Fort Wayne
United StatesRekrutierend» Google-MapsAshland-Bellefonte Cancer Center
41101 Ashland
United StatesRekrutierend» Google-MapsDana-Farber Cancer Institute
02215 Boston
United StatesNoch nicht rekrutierend» Google-MapsWashington University School of Medicine
63110 Saint Louis
United StatesNoch nicht rekrutierend» Google-MapsDana-Farber Cancer Institute
45267 Cincinnati
United StatesNoch nicht rekrutierend» Google-MapsGettysburg Cancer Center
17325 Gettysburg
United StatesRekrutierend» Google-MapsSt Vincents Hospital Melbourne
03065 Fitzroy
AustraliaNoch nicht rekrutierend» Google-MapsPeter MacCallum Cancer Centre
8006 Victoria
AustraliaNoch nicht rekrutierend» Google-MapsLandeskrankenhaus Salzburg
5020 Salzburg
AustriaNoch nicht rekrutierend» Google-MapsCHU UCL Namur Site Sainte Elisabeth
5000 Namur
BelgiumNoch nicht rekrutierend» Google-MapsLiga Norte Riograndense Contra o Câncer, Avenida Miguel Castro
59062-000 Natal
BrazilNoch nicht rekrutierend» Google-MapsHospital de Caridade de Ijui, Avenida David Jose Martins
98700-000 Ijuí
BrazilNoch nicht rekrutierend» Google-MapsCentro Gaúcho Integrado, Rua Costa
90110-270 Porto Alegre
BrazilNoch nicht rekrutierend» Google-MapsHospital de Base de Sao Jose do Rio Preto, Av. Brigadeiro Faria Lima
15090-000 São José Do Rio Preto
BrazilNoch nicht rekrutierend» Google-MapsFundação Pio XII- Hospital de Cancer de Barretos, Rua Antenor Duarte Vilela
14784-400 Barretos
BrazilNoch nicht rekrutierend» Google-MapsHospital Santa Rita, Centro de Pesquisa Clínica Novos Tratamentos Em Câncer
90050-170 Porto Alegre
BrazilNoch nicht rekrutierend» Google-MapsCEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - FMABC - Faculdade de Medicina do ABC
09060-650 Santo André
BrazilNoch nicht rekrutierend» Google-MapsHigh Technology Hospital Medcenter
6000 Batumi
GeorgiaNoch nicht rekrutierend» Google-MapsEvex Hospitals Oncology Center
4600 Kutaisi
GeorgiaRekrutierend» Google-MapsAcademician Fridon Todua Medical Center-Ltd Research Institute of Clinical Medicine
0112 Tbilisi
GeorgiaRekrutierend» Google-MapsNew Hospitals
0114 Tbilisi
GeorgiaRekrutierend» Google-MapsInstitute of Clinical Oncology
0159 Tbilisi
GeorgiaRekrutierend» Google-MapsSimon Khechinashvili University Clinic
0179 Tbilisi
GeorgiaRekrutierend» Google-MapsCancer Research Cent 4
0186 Tbilisi
GeorgiaRekrutierend» Google-MapsLEPL First University Clinic of Tbilisi State Medical University
141 Tbilisi
GeorgiaRekrutierend» Google-MapsOrszagos Onkologiai Intezet Sugarterapias Osztaly
1122 Budapest
HungaryNoch nicht rekrutierend» Google-MapsUzsoki Utcai Korhaz Onkologiai Osztaly
1145 Budapest
HungaryNoch nicht rekrutierend» Google-MapsPetz Aladár Megyei Kórház Onkoradiológiai Osztály
9024 Győr
HungaryNoch nicht rekrutierend» Google-MapsPusan National University Hospital
49241 Busan
Korea, Republic ofNoch nicht rekrutierend» Google-MapsPusan National University Yangsan Hospital, Oncol & Hematology
50612 Yangsan
Korea, Republic ofNoch nicht rekrutierend» Google-MapsInselspital, Bern University Hospital, Universitätsklinik für Radio-Onkologie
3010 Bern
SwitzerlandNoch nicht rekrutierend» Google-MapsHopitaux Universitaires de Geneve
1205 Geneve
SwitzerlandNoch nicht rekrutierend» Google-MapsCentre Hospitalier Universitaire Vaudois Lausanne
1011 Lausanne
SwitzerlandNoch nicht rekrutierend» Google-MapsMedical center ASKLEPION LLC
8173 Khodosivka
UkraineNoch nicht rekrutierend» Google-MapsKiev City Clinical Oncology Centre
3115 Kiev
UkraineNoch nicht rekrutierend» Google-MapsMedical center of Yuriy Spizhenko, Soborna Vulytsia
8111 Kyiv
UkraineNoch nicht rekrutierend» Google-Maps
Alle anzeigen 34607 Weeki Wachee
United StatesNoch nicht rekrutierend» Google-MapsColumbus Regional Research Institute
31904 Columbus
United StatesRekrutierend» Google-MapsIACT Health, John B. Amos Cancer Center
31904 Columbus
United StatesNoch nicht rekrutierend» Google-MapsInventa Center for Cancer Research At Fort Wayne Medical Oncology and Hematology
46804 Fort Wayne
United StatesRekrutierend» Google-MapsAshland-Bellefonte Cancer Center
41101 Ashland
United StatesRekrutierend» Google-MapsDana-Farber Cancer Institute
02215 Boston
United StatesNoch nicht rekrutierend» Google-MapsWashington University School of Medicine
63110 Saint Louis
United StatesNoch nicht rekrutierend» Google-MapsDana-Farber Cancer Institute
45267 Cincinnati
United StatesNoch nicht rekrutierend» Google-MapsGettysburg Cancer Center
17325 Gettysburg
United StatesRekrutierend» Google-MapsSt Vincents Hospital Melbourne
03065 Fitzroy
AustraliaNoch nicht rekrutierend» Google-MapsPeter MacCallum Cancer Centre
8006 Victoria
AustraliaNoch nicht rekrutierend» Google-MapsLandeskrankenhaus Salzburg
5020 Salzburg
AustriaNoch nicht rekrutierend» Google-MapsCHU UCL Namur Site Sainte Elisabeth
5000 Namur
BelgiumNoch nicht rekrutierend» Google-MapsLiga Norte Riograndense Contra o Câncer, Avenida Miguel Castro
59062-000 Natal
BrazilNoch nicht rekrutierend» Google-MapsHospital de Caridade de Ijui, Avenida David Jose Martins
98700-000 Ijuí
BrazilNoch nicht rekrutierend» Google-MapsCentro Gaúcho Integrado, Rua Costa
90110-270 Porto Alegre
BrazilNoch nicht rekrutierend» Google-MapsHospital de Base de Sao Jose do Rio Preto, Av. Brigadeiro Faria Lima
15090-000 São José Do Rio Preto
BrazilNoch nicht rekrutierend» Google-MapsFundação Pio XII- Hospital de Cancer de Barretos, Rua Antenor Duarte Vilela
14784-400 Barretos
BrazilNoch nicht rekrutierend» Google-MapsHospital Santa Rita, Centro de Pesquisa Clínica Novos Tratamentos Em Câncer
90050-170 Porto Alegre
BrazilNoch nicht rekrutierend» Google-MapsCEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - FMABC - Faculdade de Medicina do ABC
09060-650 Santo André
BrazilNoch nicht rekrutierend» Google-MapsHigh Technology Hospital Medcenter
6000 Batumi
GeorgiaNoch nicht rekrutierend» Google-MapsEvex Hospitals Oncology Center
4600 Kutaisi
GeorgiaRekrutierend» Google-MapsAcademician Fridon Todua Medical Center-Ltd Research Institute of Clinical Medicine
0112 Tbilisi
GeorgiaRekrutierend» Google-MapsNew Hospitals
0114 Tbilisi
GeorgiaRekrutierend» Google-MapsInstitute of Clinical Oncology
0159 Tbilisi
GeorgiaRekrutierend» Google-MapsSimon Khechinashvili University Clinic
0179 Tbilisi
GeorgiaRekrutierend» Google-MapsCancer Research Cent 4
0186 Tbilisi
GeorgiaRekrutierend» Google-MapsLEPL First University Clinic of Tbilisi State Medical University
141 Tbilisi
GeorgiaRekrutierend» Google-MapsOrszagos Onkologiai Intezet Sugarterapias Osztaly
1122 Budapest
HungaryNoch nicht rekrutierend» Google-MapsUzsoki Utcai Korhaz Onkologiai Osztaly
1145 Budapest
HungaryNoch nicht rekrutierend» Google-MapsPetz Aladár Megyei Kórház Onkoradiológiai Osztály
9024 Győr
HungaryNoch nicht rekrutierend» Google-MapsPusan National University Hospital
49241 Busan
Korea, Republic ofNoch nicht rekrutierend» Google-MapsPusan National University Yangsan Hospital, Oncol & Hematology
50612 Yangsan
Korea, Republic ofNoch nicht rekrutierend» Google-MapsInselspital, Bern University Hospital, Universitätsklinik für Radio-Onkologie
3010 Bern
SwitzerlandNoch nicht rekrutierend» Google-MapsHopitaux Universitaires de Geneve
1205 Geneve
SwitzerlandNoch nicht rekrutierend» Google-MapsCentre Hospitalier Universitaire Vaudois Lausanne
1011 Lausanne
SwitzerlandNoch nicht rekrutierend» Google-MapsMedical center ASKLEPION LLC
8173 Khodosivka
UkraineNoch nicht rekrutierend» Google-MapsKiev City Clinical Oncology Centre
3115 Kiev
UkraineNoch nicht rekrutierend» Google-MapsMedical center of Yuriy Spizhenko, Soborna Vulytsia
8111 Kyiv
UkraineNoch nicht rekrutierend» Google-Maps
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 or any excipient known to be present in
Debio1143 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:
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