NCT03215264

To Determine the Safety of Regorafenib, Hydroxychloroquine, and Entinostat Metastatic Colorectal Cancer

Phase I/II Trial of Regorafenib, Hydroxychloroquine, and Entinostat in Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to find the best dose of hydroxychloroquine (HCQ) when given in combination with regorafenib and entinostat.

Detailed description

This was a 3+3 phase I trial of HCQ and entinostat with regorafenib in patients with metastatic CRC. The primary objective was safety and the secondary objective was clinical efficacy. The trial was intended to be a Phase 1/2 trial, but the trial never moved forward to Phase 2.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	hydroxychloroquine	600-1200mg daily
DRUG	entinostat	3-5mg weekly
DRUG	regorafenib	160mg daily

Timeline

• Start date: 2017-10-02
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2017-07-12
• Last updated: 2023-11-09
• Results posted: 2023-11-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study