An Open Label Extension Study Evaluating the Safety of Long Term Dosing of AMG 531 in Thrombocytopenic Subjects with Myelodysplastic Syndromes (MDS)
- Conditions
- ow or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)MedDRA version: 9.1Level: LLTClassification code 10028533Term: Myelodysplastic syndrome
- Registration Number
- EUCTR2007-001516-24-SE
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
Disease related:
• Completion of an End of Study visit in AMG 531 study 20050159 or 20060198 for the treatment of thrombocytopenia in subjects with IPSS low to int-1 MDS.
Demographic:
• Eastern Cooperative Oncology ( ECOG) performance status of 0-2
Laboratory:
• Adequate Liver Function, as evidenced by a serum bilirubin = 1.5 times the laboratory normal range ( except for patients with a confirmed diagnosis of Gilbert’s Disease) or an ALT and AST = 3 times the laboratory normal range
• A serum creatinine concentration = 2 mg/dl
• Platelet count = 50 x 10-9/ L
General:
• Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Disease Related:
• Evidence of progression/transformation of disease (ie increase in bone marrow myeloblasts by = 5% or worsening cytogenetics)
• Prior history of leukemia or aplastic anemia
• Prior history of bone marrow or stem cell transplantation
• Prior malignancy (other than in situ cervical cancer, controlled prostate cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for = 3 years before randomization
• Active or uncontrolled infections
• Unstable angina, congestive heart failure [NYHA > class II], uncontrolled hypertension [diastolic > 100 mmHg], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction
• History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past year
• History of venous thrombosis that currently requires anti-coagulation therapy
Medications:
• Received IL-11 within 4 weeks of screening
• Receipt of hypomethylating agents or immunomodulating agents, high-dose chemotherapy targeted at MDS, or histone deacetylase inhibitors
• Have previously received any other thrombopoietic growth factor
• Known hypersensitivity to any recombinant E coli-derived product (eg, Infergen, Neupogen, Somatropin, and Actimmune)
General:
• Subject currently is enrolled in or has not yet completed at least 4 weeks since ending investigational device or drug study(s) (other than AMG 531), or subject is receiving other investigational agent(s)
• Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breast feeding
• Subject is not using adequate contraceptive precautions
• Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
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