- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02955940
An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib
An Open-Label, Multicenter, Rollover Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Expanded Access
Contacts and Locations
Study Locations
-
-
California
-
Santa Monica, California, United States, 90404
- UCLA Healthcare Hematology-Oncology
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- University of Louisville
-
-
New York
-
Clifton Park, New York, United States, 12065
- New York Oncology Hematology Pc.
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Tennessee Oncology
-
-
Texas
-
Houston, Texas, United States, 77005
- Renovatio Clinical
-
Houston, Texas, United States, 77030
- University of Texas, Md Anderson Cancer
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ruxolitinib
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.
|
5 mg BID
Other Names:
|
Experimental: Ruxolitinib plus background cancer therapy
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.
|
5 mg BID
Other Names:
Capecitabine at the same dose provided in the parent study at the time of the rollover.
Other Names:
Regorafenib at the same dose provided in the parent study at the time of the rollover.
Other Names:
|
Experimental: Background cancer therapy alone
Capecitabine and Regorafenib at the same dose provided in the parent study at the time of the rollover.
|
Capecitabine at the same dose provided in the parent study at the time of the rollover.
Other Names:
Regorafenib at the same dose provided in the parent study at the time of the rollover.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency and types of adverse events and serious adverse events
Time Frame: 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.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Peter Langmuir, MD, Incyte Corporation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INCB 18424-270
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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