Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Adults Receiving Ruxolitinib as Therapy for Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis With Progressive or Relapsed Disease (Madison)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of idelalisib in adults receiving ruxolitinib as therapy for intermediate to high-risk primary myelofibrosis (PMF), post-polycythemia vera, or post-essential thrombocythemia myelofibrosis (post-PV MF or post-ET MF) with progressive or relapsed disease.
This is a dose-escalation study. There will be 4 cohorts (A, B, C, D). Participants will receive an escalating dose or dose frequency of idelalisib based on the safety data of available cohort(s).
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
- Individuals must have been on a stable dose of ruxolitinib for at least 4 weeks prior to study entry
- Individuals with PMF, post-PV MF, or post-ET MF classified as high risk or intermediate risk as defined by the Dynamic International Prognostic Scoring System (DIPSS) for PMF or DIPSS Plus, if cytogenetics are available
- Individuals with PMF, post-PV MF, or post-ET MF who are receiving ruxolitinib and meet 2013 Revised International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European Leukemia Net (ELN) response criteria with progressive and relapsed disease, with modifications for progressive disease complete remission (CR), partial remission (PR), or clinical improvement (CI)
- European Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Required screening laboratory values as described in the protocol
- Willing and able to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions including mandatory prophylaxis for pneumocystis jiroveci pneumonia (PJP)
- Able to understand and willing to sign the informed consent form
Key Exclusion Criteria:
- Individuals on a stable ruxolitinib dose of 5 mg once daily
- History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
- Ongoing drug-induced liver injury, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver
- Ongoing drug-induced pneumonitis
- Ongoing inflammatory bowel disease
- Ongoing alcohol or drug addiction
- Symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
- Known hypersensitivity to the study investigational medicinal product (IMP), the metabolites, or formulation excipients
- Unwilling or unable to take oral medication
- Unresolved non-hematologic toxicities from prior therapies that are > Common terminology Criteria for Adverse Events (CTCAE) Grade 1 (with the exception of alopecia [Grade 1 or 2 permitted])
- Pregnant or lactating females
- Cytomegalovirus (CMV): Ongoing infection, treatment, or prophylaxis within the past 28 days
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Trial design
Primary purpose
Allocation
Interventional model
Masking
10 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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