Phase II Study of Imatinib (Glivec) Administered as a Daily Oral Treatment in Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck Overexpressing KIT
Patients with relapsing and/or metastatic adenoid cystic carcinoma of the salivary gland of
the head and neck are usually poor responders to conventional cytotoxic chemotherapy.
The investigation of proliferation pathways involving tyrosine kinase receptors such as
c-kit receptor (KIT) and PDGF receptor may allow to identify a molecular target for novel
therapeutic approaches in patients with adenoid cystic carcinoma who failed locoregional
Several publications in the literature and the pathological study we conducted in Institut
Gustave Roussy show that KIT overexpression is observed in at least 80-90% of the cases of
adenoid cystic carcinoma, supporting the investigation of imatinib in patients with adenoid
cystic carcinoma overexpressing KIT.
Imatinib is an orally administrated, well tolerated compound that could be given on an
outpatient schedule to patients with relapsing/metastatic adenoid cystic carcinoma of the
head and neck.
Because of the infrequent occurrence of salivary gland malignancies, a multicenter trial
will be mandatory and the study will include at least 2 centers represented by Institut
Gustave Roussy, Villejuif; and Hôpital Georges-Pompidou, Paris.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess progression-free survival under treatment with imatinib mesylate in patients with relapsing/metastatic adenoid cystic carcinoma of the head and neck overexpressing KIT.
at 6 months
Sandrine Faivre, MD
Centre Hospitalier de Beaujon
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
CSTI BFR 17