Ruxolitinib Continuation for Cancer
Recruiting in Palo Alto (17 mi)
+10 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Incyte Corporation
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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 Criteria
This trial is for patients already in an Incyte-sponsored ruxolitinib study that's ended or stopped. They should have stable disease, be tolerating and benefiting from their current treatment (ruxolitinib alone, with other cancer drugs, or just the cancer drugs), and must have followed the original study rules.Inclusion Criteria
Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements
I am currently seeing positive effects from my cancer treatment, as confirmed by my doctor.
My condition is not worsening according to my doctor.
+2 more
Exclusion Criteria
I can get ruxolitinib or other cancer treatments not provided by the study.
Has been permanently discontinued from study treatment in the parent study for any reason
Participant Groups
The trial provides ongoing access to ruxolitinib for those who were part of previous studies. It examines continued use of ruxolitinib by itself, combined with standard cancer treatments like Capecitabine and Regorafenib, or these treatments on their own.
3Treatment groups
Experimental Treatment
Group I: Ruxolitinib plus background cancer therapyExperimental Treatment3 Interventions
Study treatment for participants should be the same as the dosage from the parent study at the time the roll over protocol is initiated. Dose modifications are permitted.
Group II: RuxolitinibExperimental Treatment1 Intervention
Study treatment for participants should be the same as the dosage from the parent study at the time the roll over protocol is initiated. Dose modifications are permitted.
Group III: Background cancer therapy aloneExperimental Treatment2 Interventions
Capecitabine and Regorafenib at the same dose provided in the parent study at the time of the rollover.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Renovatio ClinicalHouston, TX
Renovatio Clinical Consultants LlcThe Woodlands, TX
University of Texas, Md Anderson CancerHouston, TX
UCLA Healthcare Hematology-OncologySanta Monica, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Incyte CorporationLead Sponsor