Study of Ruxolitinib in Colorectal Cancer Patients

Summary

The purpose of this study was to determine if ruxolitinib, in combination with regorafenib, is safe and effective in the treatment of metastatic colorectal cancer.

Timeline

Start

2014-03

Primary completion

2016-02

Completion

2016-12

Outcome

Missed primary endpoint

Stopped (Business): “Substudy 1 was terminated for futility at interim analysis and Substudy 2 was terminated per sponsor decision.”

registry Substudy 1: Ruxolitinib + Regorafenib vs Substudy 1: Placebo + Regorafenib; p = 0.588; Hazard Ratio (HR) 1.04 (95% CI 0.73 to 1.49) NCT02119676 ↗

registry Substudy 2: Ruxolitinib + Regorafenib vs Substudy 2: Placebo + Regorafenib; p = 0.136; Hazard Ratio (HR) 0.77 (95% CI 0.48 to 1.23) NCT02119676 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ruxolitinib	Small molecule	15 mg	Oral
Subject	Ruxolitinib	Small molecule	20 mg	Oral
Background	Regorafenib	Small molecule	160 mg	—

Indications