Etude de phase 2 évaluant l’effet clinique du sacituzumab govitecan chez des patients ayant des tumeurs solides métastatiques

Essai clinique

Type : Industriel
Statut : Ouvert
Phase : II
Étape du traitement : Thérapie ciblée
Date d'ouverture : 15/10/2019
Date clôture : 28/02/2025
Promoteur : Gilead Sciences
Progression du cancer: À distance
Résumé :

The primary objective of this study is to assess the objective response rate (ORR) of sacituzumab govitecan-hziy in adult participants with metastatic solid tumors.

Domaines/spécialités :
  • Cancers gynécologiques
    • Endomètre
  • Cancers thoraciques respiratoires
    • Cancer bronchique non à petites cellules
    • Cancer bronchique à petites cellules
  • Cancer de la tête et du cou
Pathologies :
  • Tumeur maligne des bronches et du poumon - Cim10 : C34
  • Tumeur maligne de l'endomètre - Cim10 : C541
  • Tumeur maligne de siège mal défini de la tête, de la face et du cou - Cim10 : C760
Liens externes :

Critères de population

Sexe : Homme et femme
Age minimum : 18 ans
Critères d’inclusion :

  • Individuals with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors

    • NSCLC (adenocarcinoma or SCC) that has progressed after prior platinum-based chemotherapy and programmed death-(ligand) 1 (PD-(L)1) directed therapy
    • HNSCC that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed
    • Endometrial carcinoma that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed.
    • Extensive stage SCLC that has progressed after prior platinum-based chemotherapy and PD-(L)1 directed therapy. No more than one prior line of systemic treatment is allowed (re-challenge with the same initial regimen is not allowed)
  • Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1
  • Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation
  • Adequate hepatic and renal function (CrCl ≥30mL/min)
  • Individual must have at least a 3-month life expectancy
  • Have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Critères d’exclusion :
  • Have had a prior anti-cancer biologic agent within 4 weeks prior to study Day 1 or have had prior chemotherapy, targeted small molecule therapy, radiation therapy within 2 weeks prior to Study Day 1
  • Have not recovered (i.e., ≤ Grade 1) from adverse events due to a previously administered agent
  • Have previously received topoisomerase I inhibitors
  • Have an active second malignancy
  • Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Individuals with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases and are taking ≤20 mg/day of prednisone or its equivalent. All individuals with carcinomatous meningitis are excluded regardless of clinical stability
  • Additional cohort specific exclusion criteria

Centre d'investigation

En cours
Nom : Centre Georges François Leclerc - CGFL
Ville : DIJON (21)
RESPONSABLE MÉDICAL
Nom : Dr ZANETTA
Prénom : Sylvie
Téléphone : Non disponible
Email : szanetta@cgfl.fr
CONTACT TECHNIQUE
Nom : LE BERRE
Prénom : Kevin
Téléphone : 03 80 73 77 51
Email : kleberre@cgfl.fr

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