Last updated: 11/03/2018 20:04:09
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
A Randomized, Blinded, Placebo-Controlled, Dose Finding Study to Assess the Safety and Efficacy of the Oral Thrombopoietin Receptor Agonist, Eltrombopag, Administered to Subjects with Acute Myelogenous Leukaemia (AML) Receiving Induction Chemotherapy
GSK study ID
117146
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: A Randomized, Blinded, Placebo-Controlled, Dose Finding Study to Assess the Safety and Efficacy of the Oral Thrombopoietin Receptor Agonist, Eltrombopag, Administered to Subjects with Acute Myelogenous Leukaemia (AML) Receiving Induction Chemotherapy
Trial description: The purpose of this randomized, blinded, placebo-controlled study is to provide clinical safety and exploratory efficacy data on the use of Eltrombopag in adult subjects with Acute Myeloid Leukemia (AML) receiving standard induction chemotherapy with daunorubicin plus cytarabine. These safety data are considered necessary to further development of Eltrombopag in both adult and paediatric patients suffering from malignant diseases with secondary thrombocytopenia. A minimum of 120 evaluable subjects with newly diagnosed with AML will be stratified by antecedent malignant hematologic disorder and age.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Worst-case post Baseline change in blood pressure values from Baseline
Timeframe: Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)
Worst-case post Baseline change in temperature values from Baseline
Timeframe: Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)
Worst-case change from Baseline in pulse rate values
Timeframe: Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)
Number of participants with worst-case changes from Baseline in the Eastern Cooperative Oncology Group (ECOG) performance status
Timeframe: Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)
Change from baseline in the left ventricular ejection fraction (LVEF).
Timeframe: Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)
Number of participants with worst-case changes from Baseline in electrocardiogram (ECG) values
Timeframe: Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)
Number of participants with worst-case grade changes from Baseline in the clinical chemistry parameters
Timeframe: Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)
Number of participants with any adverse events (AE) and any serious adverse events (SAE) as a measure of safety and tolerability.
Timeframe: From the time the first dose of study treatment was administered until 30 days following discontinuation of investigational product regardless of initiation of a new cancer therapy or transfer to hospice
Number of participants with worst-case grade changes from Baseline in the hematology parameters
Timeframe: Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)
Number of participants with liver events.
Timeframe: 8 weeks
Secondary outcomes:
Not applicable
Interventions:
Drug: Eltrombopag
Drug: Placebo
Drug: Daunorubicin
Drug: Cytarabine
Enrollment:
148
Observational study model:
Not applicable
Primary completion date:
2015-13-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Leukaemia, Acute
Product
AH23711, cytarabine, eltrombopag
Collaborators
None
Study date(s)
September 2013 to March 2017
Type
Interventional
Phase
2/3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Inclusion Criteria
- Age >=18 years
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria
- Age >=18 years
- Diagnosed with AML according to the WHO 2008 classification. Note: subjects with secondary AML following Myelodysplastic syndrome or secondary to previous leukemogenic therapy are allowed provided that a record of previous MDS history or leukemogenic therapy history is available.
- Eligible for induction by daunorubicin + cytarabine.
- Eligible to give informed consent to participate in the study.
- Have adequate baseline organ function defined by the following criteria: Total bilirubin <=1.5 x upper limit of normal (ULN) except for Gilbert’s syndrome, or other conditions that are not indicative of inadequate liver function (i.e. elevation of indirect bilirubin (haemolytic) in the absence of alanine aminotransferase [ALT] abnormality). ALT <=3 x ULN. Serum Creatinine <=2.5 x ULN.
- Adequate cardiac function with LVEF >=50% as assessed by echocardiogram (ECHO) or Multi Gated Acquisition Scan (MUGA.
- Subjects with a QT interval corrected for heart rate according to Bazett’s formula (QTcB) <450millisecond (msec) or <480msec for subjects with bundle branch block. The QTc should be based on single or averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period.
- Women must be either of non-childbearing potential or women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study.
- Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from time of randomization until 30 days after the last dose of investigational product.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception during the study and for 30 days following the last dose of investigational product. Exclusion Criteria
- A diagnosis of acute promyelocytic (M3) or acute megakaryocytic leukaemia (M7).
- Previous history of exposure to an anthracycline compound.
- Previous AML treatment (other than hydroxyurea).
- 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.
- 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 exclusion.
- Treatment with an investigational drug within 30 days or 5 half lives, whichever is longer, preceding the first dose of study medication.
- Current and continued use during study treatment period of known Breast cancer resistance protein (BCRP) inhibitors or known P-gp inhibitors.
- Known active hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection.
- Known hypersensitivity to any of the study drugs or its excipients.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
No longer a GSK study
Actual primary completion date
2015-13-03
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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