An Open Label, Sequential Cohort, Dose Escalation Study to Evaluate the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects with Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
- Conditions
- Myelodysplasia10018865
- Registration Number
- NL-OMON29957
- Lead Sponsor
- Amgen B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 2
Diagnosis of MDS using the World Health Organization classification.
Low or intermediate-1 MDS using the IPSS.
Mean of two platelet counts taken within 1 week prior to dosing must be equal to or less than 50 x 10 9/l and no individual count higher than 55 x 10 9/L.
Currently receiving any treatment for MDS other than supportive care.
Clinically significant bleeding within 2 weeks of screening (i.e. 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 or more years.
History of heart disease or thrombo-embolic disease
Untreated B12 or folate deficiency.
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 within 4 weeks of screening
Have ever previously received rTPO, PEG-rHuMGDF, eltrombopag or AMG 531.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1) Incidence ans severtity of all adverse events. 2) To define the maximum<br /><br>tolerated dose. 3) To evaluate anti-AMG 531 antibodies.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Percentage of patients with a complete (increase of thrombocytes to 100 x 109/l<br /><br>or more) or major (absolute increase of thrombocytes of 30 x109/l or more)<br /><br>thrombocyte response.</p><br>