drugset / Trial / NCT04310176
Valproic Acid in Combination With Bevacizumab and Oxaliplatin/Fluoropyrimidine Regimens in Patients With Ras-mutated Metastatic Colorectal Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |