Etude : TED14856/SERD / SERD



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : TED14856/SERD

Nom : SERD

Traitement : Métastasique ou localement avancé

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 19/09/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Étude de Phase I/II évaluant la sécurité, l’efficacité, la pharmacocinétique et la pharmacodynamique du SAR439859, administré par voie orale en monothérapie puis en association avec le palbociclib chez des femmes post-ménopausées atteintes d’un cancer du sein avancé avec des récepteurs aux oestrogènes positifs

Spécialité : Seins, organes génitaux de la femme
Localisation : C50 - Tumeur maligne du sein
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Primary Objectives:
- Dose Escalation: Part A (SAR439859 monotherapy); Part C (combination of SAR439859 with palbociclib)
- To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR439859 based on the dose-limiting toxicity (DLT) observance in monotherapy (Part A), and in combination with palbociclib (Part C)
- Dose Expansion: Part B (SAR439859 monotherapy); Part D (combination SAR439859 with palbociclib)
- To assess antitumor activity by Objective Response Rate (ORR) at the SAR439859 recommended dose in monotherapy (Part B), and in combination with palbociclib (Part D)

Secondary Objectives:
- Overall safety profile of SAR439859 as monotherapy (Parts A, B), and in combination with palbociclib (Parts C, D)
- Pharmacokinetic (PK) profile of SAR439859 as monotherapy (Parts A, B), and of SAR439859 in combination with palbociclib (Parts C, D), and of palbociclib in combination with SAR439859 (Parts C, D)
- Antitumor activity of SAR439859 as monotherapy (Part A), and in combination with palbociclib (Part C) as well as the Clinical Benefit Rate (CBR: Complete Response [CR], Partial Response [PR] and Stable Disease [SD] ≥24 weeks) in Parts A, B, C, and D
- ORR and CBR (CR, PR and SD ≥24 weeks) according to the estrogen receptor 1 (ESR1) gene mutational status (mutant and wild type) at baseline and in treatment
- Time to first tumor response (CR or PR) in Parts B and D
- Residual estrogen receptor (ER) availability with [(18)F] Fluoroestradiol Positron Emission Tomography (FES PET) scan (Part A)

Phase : I/II

Stade : Localement avancé à Métastasique

1
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : Parts A, B, C and D:
- Patients must be postmenopausal women
- Histological diagnosis of breast adenocarcinoma
- Locally advanced or metastatic disease
- Measurable disease
- Previously treated for advanced disease
- Either primary tumor or any metastatic site to be positive for Estrogen Receptors (ER+) and negative for human epidermal growth factor receptor 2 (HER2-) by immunohistochemistry (IHC)

Critères de non-inclusion : - Medical history or ongoing gastrointestinal disorders that could affect absorption of SAR439859 and/or palbociclib (including difficulties with swallowing capsules)
- Patient with any other cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or any other cancer from which the patient has been disease free for >3 years)
- Patients with known brain metastases and endometrial disorders
- Treatment with anticancer agents (including investigational drugs) less than 2 weeks before first study treatment starts (less than 4 weeks if the anticancer agents were antibodies)
- Prior treatment with another selective ER down-regulator (SERD) (except fulvestrant)
- Inadequate hematological and biochemical lab tests
- Patients with Gilbert disease
-Treatment with human immunodeficiency virus (HIV)-antiviral, antifungal and antioxidant agents less than 2 weeks before study treatment starts
- Treatment with strong and moderate CYP3A inducers/inhibitors within 2 weeks before first study treatment

Part A only:
- Patients with liver metastases only

Parts C and D only:
- Prior therapy with any selective cyclin-dependent kinase (CDK) 4/6 inhibitor
- Treatment with strong and moderate CYP3A inducers or strong CYP3A inhibitors within 2 weeks before first study treatment starts
- Medical conditions requiring concomitant medications that are metabolized by CYP3A

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03284957
Promoteur :
Sanofi
Type de sponsor : Industriel
54 rue La Boétie
75008 PARIS 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 :
Docteur Nawale HAJJAJI

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

Ouverture de l'essai : OUVERT

MAJ : 03/05/2019