An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib

Condition(s) studied

Investigational drug(s) / intervention(s)

Ruxolitinib: 5 mg BID

Capecitabine: Capecitabine at the same dose provided in the parent study at the time of the rollover.

Regorafenib: Regorafenib at the same dose provided in the parent study at the time of the rollover.

Study summary

The purpose of this study is to provide continued supply of ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone to subjects from an Incyte-sponsored study of ruxolitinib that has reached its study objectives or has been terminated.

This study will also provide another mechanism for reporting adverse events related to study drug safety.

Eligibility

Primary outcome measure(s)

• Frequency and types of adverse events and serious adverse events — Maximum duration of every 2 months (maximum duration of 1 month for subjects receiving regorafenib) from enrollment through 30-37 days after end of treatment up to 24 months.
  Subjects will be treated until disease progression or discontinuation criteria are met.

Trial sites (9)