Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Conditions
Interventions
Product Name: recombinant megakaryopoeisis-stimulating protein
Product Code: AMG 531
Pharmaceutical Form: Powder and solvent for solution for injection
Current Sponsor code: AMG 531
Concentration unit
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of MDS using the World Health Organization classification Low or intermediate-1 risk MDS using the IPSS The mean of the two platelet counts taken within 1 week prior to dosing must be =50 x 109/L, with no individual count >55 x 109/L (5 patients enrolled at the MTD must be =20 x 109/L) Subjects must be 18 years of age at the time of obtaining informed consent Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 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), ALT = 3 times the laboratory normal range, and AST = 3 times the laboratory normal range A serum creatinine concentration = 2 mg/dl (=176.8 mmol/L) 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
Exclusion criteria
Exclusion criteria: Currently receiving any treatment for MDS other than supportive care Clinically significant bleeding within 2 weeks of screening (ie: GI bleeds, intracranial hemorrhage) Prior malignancy (other than controlled prostate cancer, in situ cervical cancer or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for 3 years before screening History of coronary artery disease, congestive heart failure, uncontrolled angina or a recent (within 1 year) myocardial infarction Known history of thromboembolic disease Untreated B12 or folate deficiency Received Anti-Thymocyte Globuline (ATG) within 6 months of screening Received hypomethylating agents, immunomodulating agents, histone deacetylase inhibitors, cyclosporine or mycophenolate within 6 weeks of screening Concurrent use of granulocyte growth factors Received IL-11 (oprelvekin) within 4 weeks of screening Less than 4 weeks since receipt of any therapeutic drug or device that is not FDA approved for any indication Have ever previously received rTPO, PEG-rHuMGDF, eltrombopag, or AMG 531 Pregnant or breast feeding Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator Known hypersensitivity to any recombinant E coli-derived product Previously enrolled in this study Will not be available for follow-up assessment Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of AMG 531 in thrombocytopenic subjects with low or Intermediate-1 risk MDS.;Secondary Objective: To evaluate the platelet response of thrombocytopenic subjects with low or intermediate-1 risk MDS receiving AMG 531.;Primary end point(s): The primary endpoint is the incidence and severity of all adverse events and evaluation of antibody status. The MTD of AMG 531 in thrombocytopenic subjects with low or intermediate-1 risk MDS will be identified based on safety data. The MTD is defined as the dose where < 34% of subjects experience a related grade 3-4 toxicity. The key secondary endpoint is the proportion of subjects achieving a complete or major platelet response (platelet response defined by a modified MDS International Working Group Classification). | — |
Countries
Netherlands, Sweden, United Kingdom
Outcome results
None listed