Ruxolitinib in Combination With Regorafenib in Metastatic Colorectal Cancer
Research type
Research Study
Full title
A Randomized, Double-Blind Study of Ruxolitinib or Placebo in Combination With Regorafenib in Subjects With Relapsed or Refractory Metastatic Colorectal Cancer
IRAS ID
166755
Contact name
Harpreet Wasan
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2013-004714-18
Duration of Study in the UK
1 years, 8 months, 26 days
Research summary
Ruxolitinib is an investigational drug being developed for the treatment of colorectal cancer. This study is designed to understand how the body handles ruxolitinib when given together with another drug called regorafenib. Regorafenib is approved to treat colorectal cancer.
This research study has 2 parts. Part 1 is designed to assess the safety and tolerability of the combination of ruxolitinib plus regorafenib and also to select a safe dose. Part 2 will test the selected dose of ruxolitinib in combination with regorafenib, to see if taking these two drugs together will be more effective than regorafenib alone.
Both the drugs will be taken orally and subjects are expected to participate in the study for approximately 8 months. Participants will attend scheduled visits during which they will have a number of assessments, including: a physical examination; blood pressure, heart rate, respiratory rate, body temperature measurements; as well as blood sample collection for laboratory tests and CT scans.
The study is sponsored by Incyte Corporation. The study will be conducted globally and at several hospitals in the UK.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
14/EM/1286
Date of REC Opinion
5 Jan 2015
REC opinion
Further Information Favourable Opinion