Etude : NANORL / NBTXR3-102



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : NANORL

Nom : NBTXR3-102

Traitement : Adjuvant / Radiothérapie

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 05/08/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Essai clinique de phase I avec escalade et expansion de dose, du produit NBTX3 activé par radiothérapie conformationnelle avce modulation d'intensité (IMRT) chez des patients atteints d'un carcinome épidermoïde localement avancé de la cavité buccale ou de l'oropharynx

Spécialité : Lèvre, cavité buccale et pharynx
Localisation : C06 - Tumeur maligne de la bouche, parties autres et non précisées

Spécialité : Lèvre, cavité buccale et pharynx
Localisation : C10 - Tumeur maligne de l'oropharynx
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Patients will receive a single administration of NBTXR3 on day 1, either as an intra-arterial or intratumor injection, followed by Intensity Modulated Radiation Therapy starting 24 hours later (day 2), and up to completion of 7 weeks, i.e. 70 Grays, 2Grays/fraction. Patients whose tumor has completely shrunk will be followed for the post-radiotherapy evaluation up to the End of Treatment visit. Those patients whose tumor has not shrunk more than 50% of the baseline size, will stop the radiotherapy and may have a salvage tumor surgery. Then, all patients will be followed every 8 weeks, for the safety evaluation and cancer disease status until the end of the study.

2 arms:
- Experimental: NBTXR3 IntraTumoral injection (IT)
Single intratumor injection
- Experimental: NBTXR3 Intra-Arterial Injection (IA)
Single intra-arterial injection

Phase : I

Stade : Localement avancé à Métastatique

NA
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Patients aged ≥ 70 years old
- Patients aged ≥ 65 years old and < 70 years old with contra-indication to cisplatin
- Patients that are intolerant to cisplatine or cetuximab or that cannot receive the combination of chemoradiation
- Histologically or cytologically confirmed Squamous Cell Carcinoma (SCC) of the oral cavity or oropharynx
- T3 or T4 primary tumor or Stage III or IVA according to American Joint Committee on Cancer guidelines (AJCC, 7th Edition, 2010)
- No evidence of distant metastatic disease, as determined by a negative Positron Emission Tomography (PET Scan) or Computerized Tomography (CT Scan)
- Clinically eligible for either intra-arterial or intratumor implantation by injection
- KPS Karnofsky performance status) ≥ 70
- Adequate function of Bone marrow:
-> White Blood Cell (WBC) > 3.0 x 109/l
-> Absolute neutrophil count (ANC) >= 1.0 x 109/l
-> Platelet count >= 100 x 109/l
-> Hemoglobin >= 9.0 g/dL
- Adequate function of Kidney:
-> Creatinine <= 1.5 x ULN or creatinine clearance >= 50 mL/min/1.73m²
- Adequate function of liver:
-> AST (Aspartate aminotransferase) <= 5 x ULN
-> ALT (Alanine aminotransferase) <= 5 x ULN
-> Bilirubin <= 1.5 x ULN

Critères de non-inclusion : - Written Informed Consent not obtained, signed and dated
- Prior radiotherapy to any area within the planned radiotherapy field
- Tumor-related dyspnea
- Tumor ulceration which implies vascular risk
- Non measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- History of stroke, Coronary Artery Bypass Graft (CABG), or significant blockage of carotid arteries or coronary arteries or current blockage of coronary or carotid arteries equal to or in excess of 50% blockage
- Uncontrolled intercurrent illness including, but not limited to,ongoing or active severe infection, symptomatic congestive heart failure, acute coronary syndrome, etc.
- Medical history of life-threatening ventricular arrhythmia
- Prior or concurrent non-head and neck malignancies, excluding adequately treated basal or squamous cell cancer of the skin, and in situ cervical cancer, and any other cancer from which the subject has been cancer free for 5 years
- Concurrent treatment with any other anticancer therapy, including chemotherapy, immunotherapy, targeted therapy, gene therapy, or patients planning to receive these treatments during the study
- Patients unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures or those with severe psychiatric illness/social situations that would limit compliance with study requirements
- Patients participating in another clinical investigation at the time of signature of the informed consent
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT01946867
Promoteur :
Nanobiotix
Type de sponsor : Industriel
Nanobiotix -
75012 PARIS 12

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN

Investigateur :
Dominique DE RAUCOURT

TEC / ARC / IDE :
Karim HAMOND
k.hamond@
baclesse.unicancer.fr

Ouverture de l'essai : OUVERT

MAJ : 05/08/2019