Spots Global Cancer Trial Database for Study of LEE011plus Cetuximab in Patients With a Cancer of the Head and Neck

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Trial Identification

Brief Title: Study of LEE011plus Cetuximab in Patients With a Cancer of the Head and Neck

Official Title: Phase I Study of LEE011plus Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Study ID: NCT02429089

Conditions

Squamous Cell Carcinoma of the Head and Neck

Interventions

LEE011

Study Description

Brief Summary: In this trial, the investigators would like to investigate the activity of LEE011 associated with cetuximab (standard of care for the SCCHN patients at this stade of the disease).

Detailed Description: In the mammalian cell cycle, entry into S phase is achieved by cyclin-dependent kinases 4 and 6 (CDK4/6), which activate a family of E2F transcription factors by phosphorylating and deactivating the retinoblastoma protein (pRb). LEE011 is an orally, highly selective small molecule inhibitor of CDK4/6 that potently induces G1 arrest with sub-micromolar IC50's in a variety of pRb-positive cancer cells. A recent study showed that an inhibitor of the CDK4-CCND1 complex showed promising results in SCCHN pre-clinical models. There is a strong rationale to investigate CDK inhibitors in this disease. In phase Ib/II study as a single agent, the major toxicities observed were Grade 3 and 4 fatigue (53.8%), nausea (50.8%), neutropenia (47.7%), anemia (37.1%), leukopenia (46.2%), thrombocytopenia (34.1%), diarrhea (32.6%), vomiting (34.8%), lymphocytes count decreased (30.3%), anorexia (21.2%), hyperglycemia (21.2%), constipation (19.7%), hypoalbuminemia (18.9%), dyspnea (18.2%) and cough (16.7%).