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

• Status: Active, not recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

• Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of ruxolitinib that has completed or been terminated.

• Currently tolerating treatment in the parent protocol.

• Currently benefiting from the treatment with ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone, as determined by the investigator.

• Have at least stable disease, as determined by the investigator.

• Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.

Exclusion Criteria:

• Has been permanently discontinued from study treatment in the parent study for any reason.

• Able to access ruxolitinib and/or background cancer therapy outside of the clinical study.