A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III, MULTI-CENTRE STUDY OF ELTROMBOPAG OR PLACEBO IN COMBINATION WITH AZACITIDINE IN SUBJECTS WITH IPSS INTERMEDIATE-1, INTERMEDIATE 2 AND HIGH-RISK MYELODYSPLASTIC SYNDROMES (MDS)

GlaxoSmithKline,0 个研究点目标入组 2 人开始时间: 2014年8月26日最近更新: 2023年9月4日

研究概览

暂无简介。

•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.

•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.

发起方

GlaxoSmithKline,