A Phase 2 Dose-Finding Study of Pacritinib in Myelofibrosis Patients
Research type
Research Study
Full title
An Open-Label, Randomized, Phase 2 Dose-Finding Study of Pacritinib in Patients with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis Previously Treated with Ruxolitinib
IRAS ID
229032
Contact name
Adam Mead
Contact email
Sponsor organisation
CTI BioPharma Corp.
Eudract number
2017-001772-28
Duration of Study in the UK
1 years, 4 months, 12 days
Research summary
This is an Open-Label, Randomised, Phase 2 Dose-Finding Study of the experimental drug, Pacritinib, for patients with Myelofibrosis (MF) that aims to identify the most appropriate dosage for future studies based on risk/benefit profile. The results from this study will also help researchers to understand the safety and effectiveness of Pacritinib.
Males and females over the age of 18 are able to participate. If a participant is within a fertile age bracket, they must be willing to use effective birth control methods during the study. Participants could be on the study for a maximum of 8 months. They will be expected to attend 6 clinic visits over the course of their time on the study after screening. A global participation of about 105 people is anticipated.All participants will be randomly allocated to one of three groups. The assignment is performed by a computer. Neither the study doctor nor participant will be allowed to choose which group they are assigned to.
• Study Group 1 will take one 100-mg capsule for a total daily dose of 100 mg.
• Study Group 2 will take one 100-mg capsule for a total daily dose of 200 mg
• Study Group 3 will take two 100-mg capsules for a total daily dose of 400 mg.
The capsule(s) will be taken orally, at the same time(s) each day, with or without food.A number of assessments will be performed during the study including physical examinations, blood samples, questionnaires, eDiary completion, electrocardiograms or Multigated Acquisition (MUGA); and Computed Tomography Scans (CT Scans) or Magnetic Resonance Imagine Scans (MRI Scans) to determine disease status. These assessments will help to determine if the study drug is effective and safe.
The study will run at approximately 4 centres in the UK and is sponsored by CTI BioPharma.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
17/SC/0394
Date of REC Opinion
23 Oct 2017
REC opinion
Further Information Favourable Opinion