drugset / Trial / NCT02624128

Valproic Acid Plus Cisplatin and Cetuximab in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck

NCT02624128

Phase 2 Unknown 39 enrolled National Cancer Institute, Naples
NaSingle-groupOpen-labelTreatment

Summary

V-CHANCE is a phase 2, trial exploring the feasibility and the activity of valproic acid (VPA) in combination with the standard cisplatin-cetuximab combination in patients with recurrent/metastatic squamous cell carcinoma of the head and neck, never treated with first-line chemotherapy. The study includes an explorative analysis of the potential prognostic or predictive role of several biomarkers with the aim of improving the knowledge of the mechanisms by which VPA enhances chemotherapy effect and of identifying early predictors of treatment response/resistance.

Timeline

Start
2015-02-23
Primary completion
2019-04-11
Completion
2023-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Valproic Acid Small molecule 1500 mg Oral
Background Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous