A Study of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors
Trial Parameters
Brief Summary
The goal of this clinical trial is to learn how roginolisib works in comparison to standard treatment in adult patients with Myelofibrosis. The main questions it aims to answer is to evaluate the safety and tolerability of roginolisib when administered in combination with ruxolitinib.
Eligibility Criteria
Inclusion Criteria: 1. ≥18 years of age inclusive, at the time of signing the informed consent. 2. Capable of giving signed informed consent, which includes compliance with the requirements of this protocol. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 4. Diagnosis of MF, Post-Polycythaemia Vera Myelofibrosis MF (PPV-MF), or post-essential thrombocythemia MF (PET-MF) 5. Dynamic International Prognostic Scoring System (DIPSS) risk category of intermediate-1, intermediate-2, or high 6. Treated with ruxolitinib for ≥ 3 months with a stable dose ≥ 10 mg for a minimum of 8 weeks prior to Day 1. Furthermore, patients must show an unsatisfactory spleen reduction, such as a reduction of less than 25%, and spleen must be palpable ≥ 10 cm below the left costal margin on physical examination 7. Did not receive experimental drug therapy for MF or any other drug considered as an effective treatment for MF (e.g., danazol, hydroxyurea, interferon products) with the except