Study with SAR302503 in polycythemia vera or essential thrombocythemia

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

Diagnosis of hydroxyurea resistant or intolerant PV or ET. PV or ET defined according to the revised WHO criteria (6) PV resistance or intolerance to hydroxyurea is defined as PV patients on hydroxyurea with a hematocrit >45%, or phlebotomy twice in the last 6 months and at least once in the last 3 months (1). ET resistance or intolerance to hydroxyurea is defined as ET patients on hydroxyurea with platelet count >600 x 10 exp9/L (2). Provide written informed consent to participate.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

Less than 18 years of age. Participation in any study of an investigational agent (drug, biologic, device) within 30 days prior to initiation of study drug, unless during non-treatment phase. (Prior treatment with another JAK2 inhibitor is allowed.) Unwilling to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures. Eastern Cooperative Oncology Group performance status of 3 or 4 at study entry. Splenectomy. Contraindications for undergoing magnetic resonance imaging in patients with palpable spleens (eg, metal implants). Any chemotherapy (eg, hydroxyurea), radiophosphorus therapy, immunomodulatory drug therapy (eg, interferon-alpha), corticosteroids >10 mg/day prednisone or equivalent or anagrelide within 14 days prior to initiation of study drug Active malignancy other than PV or ET, except adequately treated basal cell carcinoma and squamous cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies that have been stable and off therapy for =5 years. Major surgery within 28 days or radiation within 3 months prior to initiation of study drug. Unable to swallow capsules. Active acute infection requiring antibiotics. Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness. Clinically active hepatitis B or C. 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. Any severe acute or chronic medical, neurological, or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with interpretation of study results and, in the Investigator’s opinion, would make the patient inappropriate for entry into this study. The following laboratory values within 14 days prior to initiation of study drug: Absolute neutrophil count (ANC) <1.5 x10 exp9/L Platelet count <50 x 10 exp9/L Serum creatinine >1.5 x the upper limit of normal (ULN) Serum amylase or lipase >1.5 x ULN Total bilirubin >1.5 x ULN Aspartate aminotransferase or alanine aminotransferase >3 x ULN (higher values [=5 x ULN] are allowed if clinically compatible with hepatic extramedullary hematopoiesis). Concomitant treatment with or use of drugs or herbal agents known to be at least moderate inhibitors or inducers CYP3A4, unless approved by the Sponsor. Presence of any gastric or other disorder that would inhibit absorption of oral medication. Known hypersensitivity to any excipients in the study drug formulation Pregnant or lactating female. Women of childbearing potential, unless using effective contraception while on study drug. Men who partner with a woman of childbearing potential, unless they agree to use effective contraception while on study drug

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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