An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib
- Conditions
- Pancreatic CancerBreast CancerColorectal Cancer (CRC)Lung Cancer
- Interventions
- Registration Number
- NCT02955940
- Lead Sponsor
- Incyte Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Background cancer therapy alone Capecitabine Capecitabine and Regorafenib at the same dose provided in the parent study at the time of the rollover. Background cancer therapy alone Regorafenib Capecitabine and Regorafenib at the same dose provided in the parent study at the time of the rollover. Ruxolitinib 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 plus background cancer therapy Capecitabine 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 plus background cancer therapy 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 plus background cancer therapy Regorafenib 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.
- Primary Outcome Measures
Name Time Method Frequency and types of adverse events and serious adverse events 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
UCLA Healthcare Hematology-Oncology
🇺🇸Santa Monica, California, 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
Sp Zoz Szpital Uniwersytecki W Krakowie Oddzial Kliniczny Hematologii
🇵🇱Krakow, Poland
Renovatio Clinical Consultants Llc
🇺🇸The Woodlands, Texas, United States
Instytut Hematologii I Transfuzjologii
🇵🇱Warszawa, Poland
Samodzielny Publiczny Szpital Kliniczny
🇵🇱Lublin, Poland
University of Louisville
🇺🇸Louisville, Kentucky, United States