Selinexor in Myelofibrosis Refractory or Intolerant to JAK1/2 Inhibitors (NCT03627403) | Clinical Trial Compass
TerminatedPhase 2
Selinexor in Myelofibrosis Refractory or Intolerant to JAK1/2 Inhibitors
Stopped: PI and Sponsor decision. Accrual was low and there was sufficient data to detect a response.
United States17 participantsStarted 2019-05-10
Plain-language summary
This is a phase II, open label, prospective, single-arm study evaluating the efficacy and safety of selinexor in patients with PMF or secondary MF (PPV-MF or PET-MF) who are refractory or intolerant to ruxolitinib and/or any other experimental JAK1/2 inhibitors.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female subject aged ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Diagnosis of primary myelofibrosis (PMF), post-essential thrombocytosis (PET-MF) or post-polycythemia vera (PPV-MF).
* Life expectancy ≥ 6 months.
* Prior treatment with ruxolitinib or any experimental JAK1/2 inhibitor with any one or more of the following:
a. Inadequate response after being on ≥ 3 months of treatment defined by: i. Palpable spleen ≥ 10 cm below the left subcostal margin on physical examination at the screening visit OR ii. Palpable spleen ≥ 5cm below the left subcostal margin on physical examination at the screening visit AND active symptoms of MF at the screening visit defined presence of 1 symptom score of ≥ 5 or two symptom scores each of ≥ 3 using the Screening Symptoms Form (Appendix 6) b. Intolerant to ruxolitinib and/or other JAK1/2 inhibitors due to any grade ≥ 3 non-hematologic AEs of or any grade ≥ 2 AEs requiring treatment discontinuation AND palpable spleen ≥ 5cm below the left subcostal margin on physical examination at the screening visit.
* Adequate organ function as defined as:
* Hematologic (≤ 28 days prior to C1D1):
* Total white blood cell (WBC) count ≥ 1000/mm3
* Absolute neutrophil count (ANC) ≥ 500/mm3
* Hemoglobin ≥ 7 g/dL
* Platelet count ≥ 30,000/mm3
For patients receiving transfusion and growth factor support, the following delays must be observed between the last administration …
What they're measuring
1
Count of Participants With Reduction in Spleen Volume