drugset
drugset / Trial / NCT04245865

Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer

NCT04245865 ↗

Phase 2 Active not recruiting 83 enrolled Vejle Hospital
RandomizedParallel-groupTriple-blindTreatment

Summary

This double blind, randomized phase II trial will investigate whether the addition of tocotrienol will improve the effect and lower the toxicity of standard chemotherapy and bevacizumab. Half of the patients will receive tocotrienol and the other half placebo. Treatment is planned for a period of maximum six months and will be discontinued earlier in case of progression or unacceptable toxicity.

Timeline

Start
2020-06-26
Primary completion
2025-03-31
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocotrienol Small molecule 300 mg Oral
Background Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Background Bevacizumab Monoclonal antibody 7.5 mg/kg Intravenous
Background Capecitabine Small molecule 2000 mg/m2 Oral
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 2800 mg/m2 Intravenous

Indications

colorectal cancer