An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib
NCT ID: NCT02955940
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
10 participants
INTERVENTIONAL
2016-11-30
2027-09-30
Brief Summary
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This study will also provide another mechanism for reporting adverse events related to study drug safety.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Ruxolitinib
5 mg BID
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.
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.
Background cancer therapy alone
Capecitabine and Regorafenib at the same dose provided in the parent study at the time of the rollover.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Able to access ruxolitinib and/or background cancer therapy outside of the clinical study.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Langmuir, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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UCLA Healthcare Hematology-Oncology
Santa Monica, California, United States
University of Louisville
Louisville, Kentucky, United States
New York Oncology Hematology Pc.
Clifton Park, New York, United States
Tennessee Oncology
Nashville, Tennessee, United States
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
Renovatio Clinical Consultants Llc
The Woodlands, Texas, United States
Sp Zoz Szpital Uniwersytecki W Krakowie Oddzial Kliniczny Hematologii
Krakow, , Poland
Samodzielny Publiczny Szpital Kliniczny
Lublin, , Poland
Instytut Hematologii I Transfuzjologii
Warsaw, , Poland
Countries
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Related Links
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An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib
Other Identifiers
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2023-507225-42-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCB 18424-270
Identifier Type: -
Identifier Source: org_study_id