A Study to Evaluate Safety and Efficacy of Panobinostat in Participants With Primary Myelofibrosis (NCT00931762) | Clinical Trial Compass
TerminatedPhase 2
A Study to Evaluate Safety and Efficacy of Panobinostat in Participants With Primary Myelofibrosis
United States35 participantsStarted 2009-08-31
Plain-language summary
This study assessed the safety and efficacy of Panobinostat as a single agent in the treatment of Primary Myelofibrosis, Post-Polycythemia Vera and Post-Essential Thrombocythemia. There were two cohorts - participants with JAK2 mutation and participants without JAK2 mutation.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Diagnosis of myelofibrosis, either primary myelofibrosis (PMF), post- polycythemia vera (PV) or post-essential thrombocythemia (ET) myelofibrosis (MF) with international prognostic scoring system (IPSS) score of 2 (intermediate risk) or 3 (high risk) plus at least one of the following:
✓. Participants must meet the following laboratory criteria:
✓. Eastern cooperative oncology group (ECOG) performance status of ≤ 2.
✓. Clinically euthyroid. Note: Participants are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism.
Exclusion criteria
✕. Prior histone deacetylases (HDAC), deacetylase (DAC), heat shock protein 90 (HSP90) inhibitors or valproic acid for the treatment of cancer.
✕. Previous treatment with JAK2 inhibitors.
✕. Any participant who has previously received radiation therapy to ≥ 30% of the bone marrow.
✕. Impaired cardiac function or clinically significant cardiac diseases.
✕. Participant with unresolved diarrhoea ≥ grade 2.
✕. Participants using medications that have a relative risk of prolonging the QT interval or inducing Torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug.
✕. Participants who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of surgery.
What they're measuring
1
Overall Response (OR) Rate Per International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) Criteria
✕. Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using an effective method of birth control. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months). Women of childbearing potential must have a negative serum pregnancy test at screening and at baseline.