Étude ouverte, de confirmation de dose et d'expansion de cohorte, multicentrique, de phase Ib/II pour évaluer l'activité antitumorale et l'innocuité de MEN1611 en association avec le cetuximab pour le traitement de patients atteints d'un cancer colorectal métastatique avec mutation PIK3CA.

Essai clinique

Type : Industriel
Statut : Ouvert
Phase : I
Étape du traitement : Traitements combinés
Date d'ouverture : 20/07/2020
Date clôture : 01/01/2024
Promoteur : Menarini Group
Progression du cancer: Loco-régional et à distance
Résumé :

This Phase Ib/II study will investigate the anti-tumour activity and safety of daily oral doses MEN1611 in combination with cetuximab in female and male patients affected by PIK3CA mutated, N-K-RAS wild-type and BRAF wild-type metastatic colorectal cancer.

MEN1611 is a potent, selective Class I phosphoinositide 3-kinase (PI3K) inhibitor. The Maximum Tolerated Dose (MTD) of MEN1611 given as single agent was assessed in a phase I trial in patients with advanced solid tumors.

This Phase Ib/II will start with a dose confirmation part (Step 1) to identify the RP2D of MEN1611 given in combination with cetuximab.

The study will continue with a cohort expansion (Step 2) to explore the anti-tumour activity of the selected MEN1611 dose level combined with cetuximab with further assessment of their safety and tolerability.

Domaines/spécialités :
  • Cancers digestifs
    • Colon
    • Rectum
Biomarqueurs :
  • PIK3CA
Pathologies :
  • Tumeur maligne du côlon - Cim10 : C18
  • Tumeur maligne du rectum - Cim10 : C20
Liens externes :

Critères de population

Sexe : Homme et femme
Age minimum : 18 ans
Critères d’inclusion :
  • Histological documentation of adenocarcinoma of the colon or rectum.
  • Progression or recurrence following prior irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens for metastatic disease.
  • Best response according to Response Evaluation Criteria in Solid Tumours criteria to the last anti-EGFR containing regimen of partial response or stable disease for at least 4 months.
  • Measurable disease according to RECIST criteria.
  • N-K-RAS (exons 2, 3 and 4) and BRAF wild-type and PIK3CA mutated.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Critères d’exclusion :
  • Previous treatment with PI3K inhibitor.
  • Brain metastases, unless treated > 4 weeks before Screening Visit and only if clinically stable and not receiving corticosteroids.
  • NCI CTCAE v5.0 Grade ≥ 2 diarrhoea.
  • History of significant, uncontrolled or active cardiovascular disease.
  • Known active or uncontrolled pulmonary dysfunction.
  • Uncontrolled diabetes mellitus (HbA1c > 7%) and fasting plasma glucose > 126 mg/dL.
  • Known history of human immunodeficiency virus infection or active infection with hepatitis C virus or hepatitis B virus.
  • Concurrent chronic immunosuppressive treatment either with steroids or other immunosuppressive agents.

Centre d'investigation

En cours
Nom : Centre Georges François Leclerc - CGFL
Ville : DIJON (21)
RESPONSABLE MÉDICAL
Nom : Pr GHIRINGHELLI
Prénom : François
Téléphone : Non disponible
Email : fghiringhelli@cgfl.fr
CONTACT TECHNIQUE
Nom : ARNAUD
Prénom : Magali
Téléphone : 03 80 73 75 00
Email : marnaud@cgfl.fr

Référentiels Oncologik

  • Côlon
  • Rectum