Etude : ProfiLER02 /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : ProfiLER02

Nom :

Traitement :

Type d'étude : Qualité de vie / Observationnelle

Dernière MÀJ : 25/06/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude multicentrique, prospective visant à évaluer la valeur ajoutée d'un profilage moléculaire en utilisant un panel étendu de profilage moléculaire (315 gènes, FoundationOne ) et un panel plus restreint (74 gènes, panel CONTROL), pour la prise en charge de patients atteints de tumeurs solides à un stade avancé.

Spécialité : Toutes tumeurs solides
Localisation : C - Toutes localisations
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : ProfiLER02 permettra de comparer deux panels de gènes différents chez 250 patients adultes, hommes ou femmes, atteints de tumeurs solides sans altérations moléculaires identifiées constituant des cibles thérapeutiques connues, comme HER2 ou EGFR. L’étude randomisée évaluera le test académique utilisé dans le cadre de ProfiLER01, et le test mis au point par Foundation Medicine Inc. (FMI), partenaire de Roche dont les solutions de séquençage de nouvelle génération (NGS) et d’analyse bioinformatique permettent de déterminer le profil génomique de la tumeur du patient. Cet essai a comme objectif principal de comparer la proportion de patients pour laquelle une thérapie ciblée, guidée par le profilage moléculaire, pourra être initiée en fonction de deux tests (académique ou FondationOne® de FMI).

Study Design:
Arm A: Tumor-based genomics according to the 324 cancer-related genes Next Generation Sequencing (NGS) panel from Foundation One (FOne panel).
Arm B: Tumor-based genomics according to the 87 cancer-related genes NGS panel performed at Centre Leon Berard "Unité de Caractérisation Tumorale" (CONTROL panel).

Phase : NA

Stade : Localement avancé à Métastatique

2, 3
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Male or female patient aged ≥ 18 years at time of inform consent signature.
- Currently treated by a first or a second line of chemotherapy for their advanced cancer (local relapse or metastatic; Immunotherapies, Endocrine therapies and Targeted therapies are not considered as a line of chemotherapy).
- Histologically confirmed diagnosis of advanced (local relapse or metastatic), incurable solid tumors from any histological types (except those listed in exclusion criteria 3).
- Availability of an adequate tumor sample to be sent imperatively to the CLB within 15 days after ICF signature by order of preference either (i1) a tumor archival FFPE block not older than 3 months prior to ICF signature or if not available :(ii2) a dedicated biopsy from one accessible lesion visible by medical imaging and accessible to percutaneous sampling with a diameter of at least 10 mm or if not feasible (3) an archival tumor sample (primary tumor or metastatic lesion) not older than 3 years at time of ICF signature. Quality (at least 20-30% of tumor cells) and quantity (sample size surface area > 5mm2 and > 90um depth) of the tumor sample have to be confirmed mandatorily within 7 days by a central pathological review before confirmation of inclusion.
- Patient's disease which is not susceptible to progress during the next 45 days following the ICF signature.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.
- Adequate organ and marrow function based on a medical records (within 21 days before randomization) as defined below :
Hemoglobin ≥ 9.0 g/dL
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
Platelets ≥ 100 x 109/L
Lymphocyte count ≥ 1 x 109/L
Serum creatinine CL > 50 mL/min per 1.73m2 using MDRD or CKD-EPI
AST and ALT ≤ 2.5 Upper Limit Normal (ULN) (up to 5 ULN may be tolerated in case of liver metastases)
Serum bilirubin ≤ 1. 5 ULN (in the absence of Gilbert's syndrome).
- Patient should understand, sign, and date the written ICF prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
- Patient must be covered by a medical insurance.

Critères de non-inclusion : - Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication.
- Any clinically significant and/or uncontrolled medical disease that could compromise the patient's ability to tolerate an anti-cancer treatment and its procedures (these conditions include but are not limited to severely impaired lung function, active gastrointestinal tract ulceration, acute or chronic uncontrolled liver disease/or severe renal disease, uncontrolled diabetes, history of HIV infection/or active viral infection (HBV, HCV), history of organ allograft or patient taking immunosuppressive treatment).
- Patient with the following advanced cancers :
Cancer bearing one of the oncogenic driver mutation: Colorectal cancer : KRAS, NRAS, HRAS and BRAF/Lung cancer: ALK, EGFR, ROS or MET/Breast cancers: RH+ and/or HER2+
High-grade serous ovarian cancers platinum-sensitive,
Liposarcoma.
Melanoma: BRAF
- Patient with non assessable tumor sample.
- Patient already included in this study for a type of cancer, can't be included a second time for the same cancer or for any other type of cancer.
- Pregnant or breastfeeding woman
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03163732
Promoteur :
Centre Léon Bérard
Type de sponsor : Institutionnel
69373 Lyon cedex 08 - 69373 Lyon cedex 08
69008 LYON 08

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Oscar Lambret - 3 Rue Frédéric Combemale - 59000 LILLE

Investigateur :
Professeur Nicolas PENEL

TEC / ARC / IDE :
Unité Intégrée de Recherche Clinique
investigation@
o-lambret.fr
03.20.29.59.35

Ouverture de l'essai : CLOS

MAJ : 25/06/2019