None listed
Conditions
Interventions
Eltrombopag will be supplied by GSK as round film-coated tablets containing eltrombopag equivalent to 50 mg (white to off-white), 200 mg and 300 mg (green) of eltrombopag free acid. Matching placebo
maximum dose 300 mg [150 mg for East Asian heritage]) in order to maintain platelet counts at a safe and effective level (i.e. a level sufficient to avoid platelet transfusions and bleeding events) as
Sponsors
GlaxoSmithKline,
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age ≥ 18 years. 2. Intermediate 1, intermediate 2 or high risk MDS by IPSS. 3. At least one platelet count < 75 Gi/L. 4. Eastern Cooperative Oncology Group (ECOG) Status 0-2. 5. Adequate baseline organ function defined by the criteria below: • total bilirubin <= 1.5x the upper limit of normal (ULN) except for Gilbert’s syndrome or cases clearly not indicative of inadequate liver function (i.e. elevation of indirect [haemolytic] bilirubin in the absence of ALT abnormality) • alanine aminotransferase (ALT) <= 3xULN • creatinine <= 2.5xULN 6. Subjects with a QTc <450msec or <480msec for subjects with bundle branch block. The QTc is the QT interval corrected for heart rate according to Fridericia’s formula (QTcF), machine or manual overread. For subject eligibility and withdrawal, QTcF will be used. For purposes of data analysis, QTcF will be used. The QTc should be based on single or averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period 7. Subject is able to understand and comply with protocol requirements and instructions. 8. Subject has signed and dated informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with hypomethylating agent or induction chemotherapy for MDS. 2. History of treatment with eltrombopag, romiplostim or other TPO-R agonists. 3. Previous allogeneic stem-cell transplantation. 4. Known thrombophilic risk factors. Exception: Subjects for whom the potential benefits of participating in the study outweigh the potential risks of thromboembolic events, as determined by the investigator. 5. Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of investigational product (eltrombopag/placebo). 6. Active and uncontrolled infections, including hepatitis B or C. 7. Known Human Immunodeficiency Virus (HIV) infection. 8. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to eltrombopag or its excipient, or azacitidine, that contraindicates the subjects’ participation. 9. Pregnant or lactating female. 10. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance with the study procedures. 11. French subjects: the French subject has participated in any study using an investigational drug during the previous 30 days.
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Korea South, Mexico, Norway, Poland, Portugal, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United States
Contacts
Public ContactNoelia Nathaly Contreras
GLAXOSMITHKLINE PERU S.A.
Outcome results
None listed