drugset / Trial / NCT02624128
Valproic Acid Plus Cisplatin and Cetuximab in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Valproic Acid | Small molecule | 1500 mg | Oral |
| Background | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |