Phase 2 Study in Japanese Patients With Intermediate-2 or High Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis With Splenomegaly
Myelofibrosis
About this trial
This is an interventional treatment trial for Myelofibrosis
Eligibility Criteria
Inclusion criteria :
- Diagnosis of primary or post-polycythemia vera or post-essential thrombocythemia myelofibrosis
- Myelofibrosis classified as high-risk or intermediate-risk level 2
- Enlarged spleen, palpable at least 5 cm below costal margin
- Active symptoms of myelofibrosis
- At least 20 years of age
- Eastern Collaborative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at study entry
- Absence of active malignancy other than myelofibrosis
- Written informed consent to participate.
Exclusion criteria:
- Splenectomy.
- Any recent chemotherapy (eg, hydroxyurea), immunomodulatory drug therapy (eg, thalidomide, interferon-alpha), immunosuppressive therapy, corticosteroids >10 mg/day prednisone or equivalent, or growth factor treatment (eg, erythropoietin), hormones (eg, androgens, danazol) within 14 days prior to initiation of study drug.
- Major surgery therapy within 28 days or radiation including spleen radiation within 6 months prior to initiation of study drug.
- Concomitant treatment with or use of pharmaceutical or herbal agents known to be moderate or severe inhibitors or inducers CYP3A4.
- Active acute infection requiring antibiotics.
- Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
- Participation in any study of an investigational agent (drug, biologic, device) within 30 days, unless during nontreatment phase.
- Prior treatment with a JAK 2 Inhibitor.
- Treatment with aspirin in doses >150 mg/day
- Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness.
- Pregnant or lactating female. Once the lactating female stop and participate in the study, she cannot re-start feeding the baby.
- Women of childbearing potential, unless using effective contraception while on study drug. Otherwise patients must be post-menopausal (at least 1 years from last menstruation without other medical reason), or surgically sterile.
- Known active (acute or chronic) Hepatitis A, B, or C; and hepatitis B and C carriers.
- Prior history of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis [NASH])
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Investigational Site Number 392010
- Investigational Site Number 392002
- Investigational Site Number 392006
- Investigational Site Number 392004
- Investigational Site Number 392008
- Investigational Site Number 392009
- Investigational Site Number 392003
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
SAR302503 300mg
SAR302503 400 mg
SAR302503 500 mg
SAR302503 will be self-administered, orally, once daily, as a single agent, in consecutive, 28-day cycles at the dose level of 300mg. SAR302503 will be taken on an empty stomach at approximately the same time each day
SAR302503 will be self-administered, orally, once daily, as a single agent, in consecutive, 28-day cycles at the dose level of 400 mg. SAR302503 will be taken on an empty stomach at approximately the same time each day
SAR302503 will be self-administered, orally, once daily, as a single agent, in consecutive, 28-day cycles at the dose level of 500 mg. SAR302503 will be taken on an empty stomach at approximately the same time each day