drugset
drugset / Trial / NCT05843188

Study of Hydroxychloroquine With FOLFIRI and Bevacizumab in DTP-high Metastatic Colorectal Cancer

NCT05843188 ↗

Phase 2 Active not recruiting 155 enrolled University Health Network, Toronto
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a two arm, 2-center, Phase II, study of 5-FU, irinotecan, bevacizumab (FOLFIRI-beva) and hydroxychloroquine (HCQ) in patients with previously untreated metastatic colorectal cancer (mCRC). Up to 155 patients will be screened for DTP-signature and up to 31 evaluable patients who are determined to be DTP-signature high will be treated with FOLFIRI-beva and HCQ. Patients will continue to receive treatments until evidence of disease progression, intolerable side effects, withdrawal of consent or death.

Timeline

Start
2023-08-09
Primary completion
2026-12-24
Completion
2026-12-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydroxychloroquine Small molecule 400 mg Oral
Background Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Background Irinotecan Small molecule 180 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications

colorectal cancer