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
2 other identifiers
interventional
10
2 countries
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 pancreatic-cancer
Started Nov 2016
Longer than P75 for phase_2 pancreatic-cancer
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2016
CompletedFirst Posted
Study publicly available on registry
November 4, 2016
CompletedStudy Start
First participant enrolled
November 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
December 17, 2025
December 1, 2025
10.8 years
November 3, 2016
December 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency and types of adverse events and serious adverse events
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.
Study Arms (3)
Ruxolitinib
EXPERIMENTALStudy 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 plus background cancer therapy
EXPERIMENTALStudy 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.
Background cancer therapy alone
EXPERIMENTALCapecitabine and Regorafenib at the same dose provided in the parent study at the time of the rollover.
Interventions
5 mg BID
Capecitabine at the same dose provided in the parent study at the time of the rollover.
Regorafenib at the same dose provided in the parent study at the time of the rollover.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
UCLA Healthcare Hematology-Oncology
Santa Monica, California, 90404, United States
University of Louisville
Louisville, Kentucky, 40202, United States
New York Oncology Hematology Pc.
Clifton Park, New York, 12065, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
Renovatio Clinical Consultants Llc
The Woodlands, Texas, 77380, United States
Sp Zoz Szpital Uniwersytecki W Krakowie Oddzial Kliniczny Hematologii
Krakow, 31-501, Poland
Samodzielny Publiczny Szpital Kliniczny
Lublin, 20-081, Poland
Instytut Hematologii I Transfuzjologii
Warsaw, 02-776, Poland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peter Langmuir, MD
Incyte Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
November 3, 2016
First Posted
November 4, 2016
Study Start
November 30, 2016
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
- Access Criteria
- Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
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