NCT03356587

A Biomarker-driven, Open Label, Single Arm, Multicentre Phase II Study of Abemaciclib in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Who Failed to Platinum-based Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Open, multicenter, single arm, phase II, biomarker driven umbrella trial for head and neck squamous cell carcinoma (FGFR inhibitor, CDK4/6 inhibitor, pan HER inhibitor, PI3K inhibitor, PD1/PD-L1 inhibitor)

Detailed description

This study will be conducted as a treatment arm 4 of the umbrella clinical trial.(NCT03292250) During or after palliative 1st line platinum based chemotherapy, we will perform prescreening NGS based molecular characterization. The molecular characterization will be done by following three methods. * NGS : Agilent SureSelect Target Enrichment (245 genes) * Nanostring nCounter including immune signature * IHC : PD-L1 The present trial will investigate the efficacy and safety of abemaciclib in patients with recurrent or metastatic HPV (-) HNSCC with genetic alterations of cell cycle pathway who failed to platinum-based therapy. We will also evaluate feasibility and the effect on decision making of next generation sequencing of HNSCC.

Conditions

• HNSCC
• Head and Neck Neoplasms

Interventions

Type	Name	Description
DRUG	Abemaciclib	Patients will be instructed to take Abemaciclib orally at a dose of 200mg bid with a glass of water twice daily, in a fasting state or with a light fat-free meal, and as close as possible to the same time each day

Timeline

• Start date: 2017-10-16
• Primary completion: 2020-01-01
• Completion: 2020-12-31
• First posted: 2017-11-29
• Last updated: 2017-11-29

Locations

1 site across 1 country: South Korea