Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-01-04 @ 3:45 AM
Study NCT ID:
NCT02624128
Status:
UNKNOWN
Last Update Posted:
2023-11-13
First Post:
2015-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Valproic Acid Plus Cisplatin and Cetuximab in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck
Sponsor:
National Cancer Institute, Naples
Organization:
Study Overview
Official Title:
Preclinical and Clinical Study of Valproic Acid Plus Cisplatin and Cetuximab in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck
Status:
UNKNOWN
Status Verified Date:
2023-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
V-CHANCE
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2014-001523-69 | EUDRACT_NUMBER | None | View |