Acute myelogenous leukemia MedDRA version: 18.1 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Relovade
Product Name: Eltrombopag
Product Code: SB-497115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-61-2
Current Sponsor code: SB-497115
Sponsors
GlaxoSmithKline Research and Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for enrolment in the study must meet all of the following inclusion criteria: 1. Age 18 years and over 2. Diagnosed with AML according to the WHO 2008 classification ? Note: subjects with secondary AML following MDS or secondary to previous leukemogenic therapy are allowed provided that a record of previous MDS history or leukemogenic therapy history is available 3. Eligible for induction by daunorubicin + cytarabine 4. Eligible to give informed consent to participate in the study 5. Have adequate baseline organ function defined by the following criteria: a. Total bilirubin=50% as assessed by echocardiogram (ECHO) or Multi Gated Acquisition Scan (MUGA) 7. Subjects with a QTc =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following exclusion criteria must not be enrolled in the study: 1. A diagnosis of acute promyelocytic (M3) or acute megakaryocytic leukaemia (M7) 2. Previous history of exposure to an anthracycline compound 3. Previous AML treatment (other than hydroxyurea) 4. Any serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the participant at an unacceptable risk if he or she were to participate in the study or would prevent that person from giving informed consent 5. History of thromboembolic event or other condition requiring ongoing use of anticoagulation either with warfarin or low molecular-weight heparin ? Note: Occlusion of a central line is not an exclusion 6. Treatment with an investigational drug within 30 days or 5 half lives, whichever is longer, preceding the first dose of study medication 7. Current and continued use during study treatment period of known BCRP inhibitors or known P-gp inhibitors (see Prohibited Medications, Section 6.2) (please see Table 2 in protocol P31.) 8. Known active hepatitis B, hepatitis C or Human immunodeficiency Virus (HIV) nfection 9. Known hypersensitivity to any of the study drugs or its excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of eltrombopag versus placebo in subjects receiving standard induction therapy for acute myeloid leukemia (AML);Secondary Objective: Secondary objectives compare the following in subjects treated with eltrombopag versus placebo: ? To assess plasma PK parameters of daunorubicin and daunorubicinol ? To assess the effects on blood counts including platelets, absolute neutrophil count (ANC), and haemoglobin ? To assess the incidence and severity of haemorrhagic events ? To assess the effect on AML disease control ? To evaluate off-treatment medical resource utilization;Primary end point(s): Safety and tolerability as assessed by adverse events (AE), changes in left ventricular ejection fraction (LVEF) and other safety data including clinical laboratory parameters for eltrombopag-treated subjects versus placebo;Timepoint(s) of evaluation of this end point: The safety endpoint is assessed within 14 days of the remission bone marrow assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Cycle 1 Day 3 daunorubicin and daunorubicinol half-life and dose-normalized plasma AUC(0-8), AUC(24-8), AUC(0-t), AUC(24-t), and Cmax 2.Cycle 2 Day 1 daunorubicin and daunorubicinol dose-normalized plasma AUC(0-24) and Cmax 3.Number of platelet transfusions 4.Time to platelet counts =>20 Gi/L and =>100 Gi/L 5.Proportion of subjects who achieve platelet count recovery by day 21 6.Summary of platelet counts 7.Duration of platelet transfusion independence 8.Time to ANC engraftment defined as ANC recovery > 0.5 Gi/L sustained for 3 days 9. Assessment of changes in absolute neutrophil counts 10. Assessment of changes in haemoglobin 11. Number of bleeding events 12. Disease response rate and type of response 13. Overall survival 14. Medical resource utilization ;Timepoint(s) of evaluation of this end point: 1. Cycle 1 Day 3 2. Cycle 2 Day 1 3. At Remission Assessment Visit 4. During treatment period 5. At Remission Assessment Visit 6. At Remission Assessment Visit 7. At Remission Assessment Visit 8. During treatment period 9. During treatment period 10. During treatment period 11. At Remission Assessment Visit 12. At Remission Assessment Visit 13. At 1- and 2- year Follow up assessment 14. At Remission Assessment Visit 15. Baseline, 7-10 days after last daunorubicin dose, 30 (±3 days) after last daunorubicin dose | — |
Countries
Australia, Belgium, Canada, Greece, Hungary, Israel, Korea, Republic of, Poland, Russian Federation, United States
Contacts
Public ContactClinical Trials Helpdesk
GlaxoSmithKline Research & Development Ltd.
Outcome results
None listed