drugset / Trial / NCT04310176

Valproic Acid in Combination With Bevacizumab and Oxaliplatin/Fluoropyrimidine Regimens in Patients With Ras-mutated Metastatic Colorectal Cancer

NCT04310176

Phase 2 Unknown 200 enrolled National Cancer Institute, Naples
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary aim of this study is to test whether the combination of valproic acid with bevacizumab and oxaliplatin/fluoropyrimidine regimens (mFOLFOX6/mOXXEL) can prolong progression free survival (PFS) as compared with bevacizumab and oxaliplatin/fluoropyrimidine regimens alone as first-line treatment in patients with metastatic colorectal cancer with mutation of RAS.

Timeline

Start
2019-05-24
Primary completion
2023-12
Completion
2024-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Valproic Acid Small molecule 1500 mg Oral
Background Bevacizumab Monoclonal antibody 5 mg/m2 Intravenous
Background Bevacizumab Monoclonal antibody 7.5 mg/m2 Intravenous
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Capecitabine Small molecule 1250 mg/m2 Oral
Background Levoleucovorin Unknown 200 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications