RUXOLITINIB for Myelofibrosis

Inclusion criteria

• {"criterion_text":"- Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of ruxolitinib that has completed or been terminated."}
• {"criterion_text":"- Currently tolerating treatment in the parent protocol."}
• {"criterion_text":"- Currently benefiting from the treatment with ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone, as determined by the investigator."}
• {"criterion_text":"- Have at least stable disease, as determined by the investigator."}
• {"criterion_text":"- Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements."}
• {"criterion_text":"- Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol."}
• {"criterion_text":"- Willingness to avoid pregnancy or fathering children based on the criteria below: a.\tWoman of nonchildbearing potential. b.\tWoman of childbearing potential who has a negative serum pregnancy test on Day 1 and who agrees to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from the first dose through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy (see Appendix A) should be communicated to the subject and their understanding confirmed. c.\tMan who agrees to take appropriate precautions to avoid fathering children (with at least 99% certainty) from the first dose through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy (see Appendix A) should be communicated to the subject and their understanding confirmed."}
• {"criterion_text":"- Ability to comprehend and willingness to sign an informed consent form (ICF)."}

Exclusion criteria

• {"criterion_text":"- Has been permanently discontinued from study treatment in the parent study for any reason."}
• {"criterion_text":"- Able to access ruxolitinib and/or background cancer therapy outside of the clinical study."}
• {"criterion_text":"- Subjects with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the subject or compliance with the Protocol."}
• {"criterion_text":"- Pregnant or breastfeeding woman."}

Primary endpoints

• {"endpoint_text":"- To assess the frequency and types of adverse events and serious adverse events reported in subjects receiving ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone.","definition_or_measurement_approach":"Assessment of the frequency and types of adverse events and serious adverse events reported in subjects receiving the listed therapies (based on reported AEs/SAEs)."}

Poland

Earliest CTIS Part Ii Submission Date

26-04-2024

Latest Decision Or Authorization Date

06-09-2024

Processing Time Days

133

Number Of Sites

3

Number Of Participants

6

Primary sponsor

Full Name

Incyte Corp.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Third parties

• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"1,12,5","organisation_type":"Pharmaceutical company"}