A Safety and Efficacy Study of Eltrombopag in Subjects With AML
Conditions
Leukaemia, Acute
Conditions: official terms
Leukemia - Leukemia, Myeloid, Acute
Conditions: Keywords
Eltrombopag, sAML/MDS, leukemia, de novo AML, acute myeloid leukemia, secondary acute myeloid, thrombocytopenia
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention
Name: Daunorubicin Type: Drug
Name: Cytarabine Type: Drug
Name: Eltrombopag Type: Drug
Name: Placebo Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Locations
GSK Investigational Site
Farmington, Connecticut, United States
Status: Not yet recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Miami, Florida, United States
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Orlando, Florida, United States
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Atlanta, Georgia, United States
Status: Not yet recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Ames, Iowa, United States
Status: Not yet recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Sioux City, Iowa, United States
Status: Not yet recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Burlington, Massachusetts, United States
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Kansas City, Missouri, United States
Status: Not yet recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Rochester, New York, United States
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Durham, North Carolina, United States
Status: Not yet recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Canton, Ohio, United States
Status: Not yet recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Providence, Rhode Island, United States
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Providence, Rhode Island, United States
Status: Not yet recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Nashville, Tennessee, United States
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Kogarah, New South Wales, Australia
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Melbourne, Victoria, Australia
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Parkville, Victoria, Australia
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Brussels, Belgium
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Leuven, Belgium
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Toronto, Ontario, Canada
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Montreal, Quebec, Canada
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Athens, Greece
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Patra, Greece
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Debrecen, Hungary
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Szeged, Hungary
Status: Not yet recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Haifa, Israel
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Holon, Israel
Status: Not yet recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Jerusalem, Israel
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Jerusalem, Israel
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Kfar Saba, Israel
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Tel-Aviv, Israel
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Seoul, Korea, Korea, Republic of
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Seoul, Korea, Republic of
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Seoul, Korea, Republic of
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Slupsk, Poland
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Wroclaw, Poland
Status: Not yet recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Kaluga, Russian Federation
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Moscow, Russian Federation
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Nizhniy Novgorod, Russian Federation
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Penza, Russian Federation
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
St'Petersburg, Russian Federation
Status: Not yet recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Tula, Russian Federation
Status: Recruiting
Contact: US GSK Clinical Trials Call Center - 877-379-3718 - GSKClinicalSupportHD@gsk.com
Start Date
September 2013
Completion Date
August 2016
Sponsors
GlaxoSmithKline
Source
GlaxoSmithKline
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page