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A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS)

Primary Purpose

Thrombocytopaenia

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Eltrombopag

Azacitidine

Placebo

About this trial

This is an interventional treatment trial for Thrombocytopaenia focused on measuring thrombocytopenia, myelodysplastic syndromes, MDS, thrombopoietin, azacitidine, Eltrombopag, myelodysplastic syndromes (MDS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age >=18 years (For subjects in Taiwan, Age >= 20 years)
MDS by World Health Organization (WHO) or French-American-British (FAB) classification
Intermediate 1, intermediate 2 or high risk MDS by IPSS
At least one platelet count < 75 Gi/L
Eastern Cooperative Oncology Group (ECOG) Status 0-2
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 alanine aminotransferase [ALT] abnormality); ALT =< 2.5xULN; creatinine =< 2.5xULN
Subjects with a corrected QT interval (QTc) <450 milliseconds (msec) 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
Subject is able to understand and comply with protocol requirements and instructions
Subject has signed and dated informed consent
Women must be either of non-child bearing 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
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception during the study and for 3 months following the last dose of study treatment
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 16 weeks after the last dose of study treatment
French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category

Exclusion Criteria:

Previous treatment with hypomethylating agent or induction chemotherapy for MDS
Proliferative type chronic myelomonocytic leukemia with white blood cell count >12 Gi/L at any time during the 28 days before Day 1
History of treatment with eltrombopag, romiplostim or other thrombopoietin receptor (TPO-R) agonists
Previous allogeneic stem-cell transplantation
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
Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of investigational product (eltrombopag/placebo)
Active and uncontrolled infections, including hepatitis B or C
Human Immunodeficiency Virus (HIV) infection
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to eltrombopag or its excipient, or azacitidine, that contraindicates the subjects' participation
Pregnant or lactating female
Any serious and/or unstable pre-existing medical condition (including any advanced malignancy other than the disease under study), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance with the study procedures
French subjects: the French subject has participated in any study using an investigational drug during the previous 30 days

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Eltrombopag

Placebo

Arm Description

Eligible subject will receive a starting dose of eltrombopag of 200 milligrams (mg) (100 mg for subjects of East Asian heritage). Dose modifications of eltrombopag will be permitted by 100 mg increments (50 mg increments for East Asians) to a lowest dose of 100 mg (50 mg for East Asian heritage) or a maximum dose of 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). Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator's assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle for as long as the subject is receiving azacitidine

Eligible subject will receive eltrombopag matching placebo. Subjects will receive azacitidine 75 mg/meter^2 subcutaneously once daily for 7 days (+/- 3 day treatment window permitted) every 28 days, for at least 6 cycles if tolerated and until they are no longer receiving benefit (defined as at least stable disease per the investigator's assessment) or until disease progression, death, or unacceptable toxicity/adverse event. The subject may receive eltrombopag daily for the full 28 days each cycle for as long as the subject is receiving azacitidine

Outcomes

Primary Outcome Measures

Number of Participants Who Were Platelet Transfusion Independent During Cycles 1-4 of Azacitidine Therapy

A subject is defined as being platelet transfusion independent if they received no platelet transfusions within the first 4 cycles of treatment with azacitidine. Subjects who died or withdrew from investigational product within the first four cycles were treated as failures (i.e. not transfusion independent) in the analysis

Secondary Outcome Measures

Overall Survival (OS)

Overall survival is defined as the time from randomization until death due to any cause and deaths have been presented. Subjects still alive at the time of the analysis and subjects who have withdrawn from the study will be censored at the time of last contact

Summary of Progression Free Survival From Investigator Assessment (ITT)

Progression-free survival, defined as the time from randomization until either disease progression or death. The modified 2006 IWG criteria for MDS used for progression assessment For patients with: Less than 5% BM blasts: ≥ 50% increase in blasts to > 5% blasts; 5% - <10% BM blasts: ≥ 50% increase to > 10% blasts; 10% - <20% BM blasts: ≥ 50% increase to > 20% blasts; 20% - 30% BM blasts: ≥ 50% increase to > 30% blasts

Summary of Progression Free Survival From Central Review (ITT)

Summary of AML Progression From Investigator Assessment and Central Review (ITT)

Progression to AML in MDS patients with baseline bone marrow blast < 20% was defined as meeting definition of disease progression according to the modified 2006 IWG response criteria for MDS with the additional requirement that bone marrow blast or peripheral blast increases from < 20% at baseline to ≥ 20% postbaseline. Progression assessment For patients with: Less than 5% BM blasts: ≥ 50% increase in blasts to > 5% blasts; 5% - <10% BM blasts: ≥ 50% increase to > 10% blasts; 10% - <20% BM blasts: ≥ 50% increase to > 20% blasts; 20% - 30% BM blasts: ≥ 50% increase to > 30% blasts

Best Disease Response From Investigator Assessment (ITT)

Best disease response is categorized as complete remission (CR), partial remission (PR), or marrow CR, stable disease, disease progression, or as non-evaluable; according to modified 2006 International Working Group (IWG) criteria for MDS

Best Disease Response From Central Review (ITT)

Hematologic Improvement (HI) in Platelets, Neutrophils, and Hemoglobin Based on the Modified IWG Criteria for MDS (ITT)

HI based on the modified IWG criteria for MDS. HI - Platelets (BL <100Gi/L), response criteria= BL <20: increase to>20 and 100% at least for 56 days or BL >=20: absolute increase of >=30. HI - Neutrophils (BL <1.0 Gi/L), response criteria=100% increase and an absolute increase >0.5 Gi/L over BL for at least 56 days. HI-Hemoglobin (BL <g/dL), response criteria=Hgb increase by >=1.5 g/dL over BL, RBC transfusions(given for Hgb<=9.0) reduced by >=4 per 8w from BL

Number of Participants Who Were Platelet Transfusion Independent (ITT Set)

Platelet transfusion independence is defined for each cycle as the number of participants who continue to the end of a cycle without requiring a platelet transfusion

Bleeding Adverse Events (AEs) >= Grade 3

Bleeding will be assessed by recording AEs or serious adverse events (SAEs) as graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Number of of Subjects With Azacitidine Dose Delays, Dose Reductions, Interruptions

The proportion of subjects with any delay, reduction or interruption in dosage of Azacitidine excluding those for non-medical reasons will be analyzed

Response Levels in All Domains of Euroquol-5 Dimensions of Health, 3 Response Levels (EQ-5D-3L™)

The EQ-5D is a general health status and health utility measure which captures 5 dimensions of health state: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. (EQ-5D is a trademark of the Stichting EuroQol Group) . C=cycle, D=Day

Functional Assessment of Chronic Disease Therapy-fatigue Subscale (FACIT-Fatigue) (ITT)

The FACIT-Fatigue subscale measures severity and impact of fatigue on functioning and Health Related QoL experienced in the past 7 days. Scale is a 13 item measure of fatigure. Items are scored on a 0-4 response scale ranging from "not at all" to "very much so". All items are summed to create a single fatigure score with a range from 0 to 52. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatiigue (The FACIT Fatigue Scale is owned by David Cella, Ph.D.)

Medical Resource Utilization (MRU): Event -Hospitalizations Inpatient and Outpatient

MRU data will be collected for each subject. Events corresponding to unscheduled (not scheduled per protocol) hospitalizations

Medical Resource Utilization (MRU): Event and Use of Site Specific Medical Resources - Non-study Laboratory Tests

MRU data will be collected for each subject. Events corresponding to unscheduled (not scheduled per protocol) hospitalizations, office visits including consultations, laboratory and diagnostic tests (lab results, imaging etc.), and procedures prior to therapy initiation and during therapy will be collected

Medical Resource Utilization (MRU): Use of Site Specific Medical Resources

Summary of Post-Hoc Estimates of Steady-state Eltrombopag Cmax and Cmin Pharmacokinetic Parameters for a 50 mg Dose

Eltrombopag concentrations were analyzed using a population PK model along with data from other studies in healthy volunteers and in patients with MDS and/or AML. Post-hoc PK parameters were derived. Only patients from this study were included (163)

Summary of Post-Hoc Estimates of Steady-state Eltrombopag AUC0 Infinity Pharmacokinetic Parameters for a 50 mg Dose

AUC0-infinity -Pharmacokinetic(s) Parameter of Azacitidine

An analysis of variance (ANOVA) on AUC0-infinity. The PK parameters were log transformed prior to analysis. The model included treatment as a fixed effect. Point estimates and their associated 90% CI were constructed for the differences in PK parameter values. The point estimates and their associated 90% CI were then back transformed to provide point estimates and 90% CI for the azacitidine + eltrombopag:azacitidine + placebo PK parameter ratios.

Cmax -Pharmacokinetic Parameter of Azacitidine

An analysis of variance (ANOVA) on Cmax . The PK parameters were log transformed prior to analysis. The model included treatment as a fixed effect. Point estimates and their associated 90% CI were constructed for the differences in PK parameter values. The point estimates and their associated 90% CI were then back transformed to provide point estimates and 90% CI for the azacitidine + ltrombopag:azacitidine + placebo PK parameter ratios.

Full Information

NCT ID

NCT02158936

First Posted

June 5, 2014

Last Updated

November 12, 2017

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02158936

Brief Title

A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS)

Official Title

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) SUPPORT: A StUdy of eltromboPag in myelodysPlastic SyndrOmes Receiving azaciTidine

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Terminated

Study Start Date

June 10, 2014 (Actual)

Primary Completion Date

April 30, 2016 (Actual)

Study Completion Date

April 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Eltrombopag olamine (SB-497115-GR) is an orally bioavailable, small molecule thrombopoietin receptor agonist that may be beneficial in medical disorders associated with thrombocytopenia. Eltrombopag has been shown to increase platelet counts in patients with thrombocytopenia from various etiologies (Idiopathic thrombocytopenic purpura [ITP], liver disease, aplastic anemia and chemotherapy induced thrombocytopenia). Approximately 350 subjects will be randomized in a 1:1 ratio (175 into the eltrombopag arm and 175 into the placebo arm). Approximately 55 subjects will be enrolled into the azacitidine. Subjects with intermediate-1, intermediate-2 or high risk MDS by IPSS, and baseline platelet count of <75 Giga (10^9) per liter (Gi/L) will only be enrolled. This is a randomized, double-blind, parallel group, placebo-controlled study designed to explore the platelet supportive care effects of eltrombopag versus placebo in combination with the standard of care hypomethylating agent, azacitidine. The primary objective of this study is to determine the effect of eltrombopag versus placebo on the proportion of subjects who are platelet transfusion free during the first 4 cycles of azacitidine therapy. Key secondary endpoints include overall survival, disease response, and disease progression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thrombocytopaenia

Keywords

thrombocytopenia, myelodysplastic syndromes, MDS, thrombopoietin, azacitidine, Eltrombopag, myelodysplastic syndromes (MDS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

356 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Eltrombopag

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Eltrombopag

Intervention Description

Eltrombopag will be round film-coated tablets containing eltrombopag equivalent to 50 mg (white to off-white), 200 mg and 300 mg (green) of eltrombopag free acid

Intervention Type

Drug

Intervention Name(s)

Azacitidine

Intervention Description

Subcutaneous Injection (IV if local standard)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Eltrombopag matching placebo tablets

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Eltrombopag matching placebo tablets will be supplied

Primary Outcome Measure Information:

Title

Number of Participants Who Were Platelet Transfusion Independent During Cycles 1-4 of Azacitidine Therapy

Description

Time Frame

4 cycles (Cycle = 28 days)

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

Randomization until death or end of study, approximately 2 years

Title

Summary of Progression Free Survival From Investigator Assessment (ITT)

Description

Time Frame

First day of each cycle (Cycles 3+), at the end of therapy visit and every 3 months in follow-up for approximately 2 years

Title

Summary of Progression Free Survival From Central Review (ITT)

Description

Time Frame

First day of each cycle (Cycles 3+), at the end of therapy visit and every 3 months in follow-up for approximately 2 years

Title

Summary of AML Progression From Investigator Assessment and Central Review (ITT)

Description

Time Frame

First day of each cycle (Cycles 3+), at the end of therapy visit and every 3 months in follow-up for approximately 2 years

Title

Best Disease Response From Investigator Assessment (ITT)

Description

Time Frame

At end of Cycle 6 (cycle=28 days) or end of therapy, whichever came first

Title

Best Disease Response From Central Review (ITT)

Description

Time Frame

At end of Cycle 6 (cycle=28 days) or end of therapy, whichever came first

Title

Hematologic Improvement (HI) in Platelets, Neutrophils, and Hemoglobin Based on the Modified IWG Criteria for MDS (ITT)

Description

Time Frame

From Day 1 to 4-week follow-up (samples collected weekly in Cycle 1, Days 1 and 15 in Cycles 2-6 and Day 1 of Cycles >=7)

Title

Number of Participants Who Were Platelet Transfusion Independent (ITT Set)

Description

Platelet transfusion independence is defined for each cycle as the number of participants who continue to the end of a cycle without requiring a platelet transfusion

Time Frame

From Day 1 to end of study treatment up to approximately 2 years

Title

Bleeding Adverse Events (AEs) >= Grade 3

Description

Bleeding will be assessed by recording AEs or serious adverse events (SAEs) as graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Time Frame

From Day 1 to 4-week follow-up up to approximately 2 years

Title

Number of of Subjects With Azacitidine Dose Delays, Dose Reductions, Interruptions

Description

The proportion of subjects with any delay, reduction or interruption in dosage of Azacitidine excluding those for non-medical reasons will be analyzed

Time Frame

From Day 1 to 4-week follow-up up to approximately 2 years

Title

Response Levels in All Domains of Euroquol-5 Dimensions of Health, 3 Response Levels (EQ-5D-3L™)

Description

Time Frame

From Day 1 to 4-week follow-up up to approximately 2 years

Title

Functional Assessment of Chronic Disease Therapy-fatigue Subscale (FACIT-Fatigue) (ITT)

Description

Time Frame

From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years

Title

Medical Resource Utilization (MRU): Event -Hospitalizations Inpatient and Outpatient

Description

MRU data will be collected for each subject. Events corresponding to unscheduled (not scheduled per protocol) hospitalizations

Time Frame

From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years

Title

Medical Resource Utilization (MRU): Event and Use of Site Specific Medical Resources - Non-study Laboratory Tests

Description

Time Frame

From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years

Title

Medical Resource Utilization (MRU): Use of Site Specific Medical Resources

Description

Time Frame

From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years

Title

Summary of Post-Hoc Estimates of Steady-state Eltrombopag Cmax and Cmin Pharmacokinetic Parameters for a 50 mg Dose

Description

Time Frame

Cycle 1, Week 2: Pre-dose, 1.5 and 3 hour post dose; Cycle 1, Week 3: 4, 5.5, and 7 hours post dose

Title

Summary of Post-Hoc Estimates of Steady-state Eltrombopag AUC0 Infinity Pharmacokinetic Parameters for a 50 mg Dose

Description

Time Frame

Cycle 1, Week 2: Pre-dose, 1.5 and 3 hour post dose; Cycle 1, Week 3: 4, 5.5, and 7 hours post dose

Title

AUC0-infinity -Pharmacokinetic(s) Parameter of Azacitidine

Description

Time Frame

Cycle 2 Day 1: Pre-dose, 15 min, 0.5, 1, 2 and 4 hr post dose

Title

Cmax -Pharmacokinetic Parameter of Azacitidine

Description

Time Frame

Cycle 2 Day 1: Pre-dose, 15 min, 0.5, 1, 2 and 4 hr post dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age >=18 years (For subjects in Taiwan, Age >= 20 years) MDS by World Health Organization (WHO) or French-American-British (FAB) classification Intermediate 1, intermediate 2 or high risk MDS by IPSS At least one platelet count < 75 Gi/L Eastern Cooperative Oncology Group (ECOG) Status 0-2 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 alanine aminotransferase [ALT] abnormality); ALT =< 2.5xULN; creatinine =< 2.5xULN Subjects with a corrected QT interval (QTc) <450 milliseconds (msec) 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 Subject is able to understand and comply with protocol requirements and instructions Subject has signed and dated informed consent Women must be either of non-child bearing 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 Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception during the study and for 3 months following the last dose of study treatment 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 16 weeks after the last dose of study treatment French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category Exclusion Criteria: Previous treatment with hypomethylating agent or induction chemotherapy for MDS Proliferative type chronic myelomonocytic leukemia with white blood cell count >12 Gi/L at any time during the 28 days before Day 1 History of treatment with eltrombopag, romiplostim or other thrombopoietin receptor (TPO-R) agonists Previous allogeneic stem-cell transplantation 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 Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of investigational product (eltrombopag/placebo) Active and uncontrolled infections, including hepatitis B or C Human Immunodeficiency Virus (HIV) infection Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to eltrombopag or its excipient, or azacitidine, that contraindicates the subjects' participation Pregnant or lactating female Any serious and/or unstable pre-existing medical condition (including any advanced malignancy other than the disease under study), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance with the study procedures French subjects: the French subject has participated in any study using an investigational drug during the previous 30 days

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06105

Country

United States

Facility Name

Novartis Investigative Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Novartis Investigative Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Novartis Investigative Site

City

Anderson

State/Province

Indiana

ZIP/Postal Code

46016

Country

United States

Facility Name

Novartis Investigative Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64128

Country

United States

Facility Name

Novartis Investigative Site

City

San Luis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Novartis Investigative Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Novartis Investigative Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Novartis Investigative Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98108

Country

United States

Facility Name

Novartis Investigative Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Buenos Aires

ZIP/Postal Code

1114

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Buenos Aires

ZIP/Postal Code

1425

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Buenos Aires

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Santa Fe

ZIP/Postal Code

S3000ADL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Novartis Investigative Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Novartis Investigative Site

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Novartis Investigative Site

City

East Melbourne

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

Facility Name

Novartis Investigative Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3000

Country

Australia

Facility Name

Novartis Investigative Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novartis Investigative Site

City

Innsbruck

ZIP/Postal Code

A-6020

Country

Austria

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Novartis Investigative Site

City

Rankweil

ZIP/Postal Code

A-6830

Country

Austria

Facility Name

Novartis Investigative Site

City

Salzburg

ZIP/Postal Code

A-5020

Country

Austria

Facility Name

Novartis Investigative Site

City

Steyr

ZIP/Postal Code

4400

Country

Austria

Facility Name

Novartis Investigative Site

City

Vienna

ZIP/Postal Code

1140

Country

Austria

Facility Name

Novartis Investigative Site

City

Brasschaat

ZIP/Postal Code

2930

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Lodelinsart

ZIP/Postal Code

6042

Country

Belgium

Facility Name

Novartis Investigative Site

City

Turnhout

ZIP/Postal Code

2300

Country

Belgium

Facility Name

Novartis Investigative Site

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30130-100

Country

Brazil

Facility Name

Novartis Investigative Site

City

Curitiba

State/Province

Paraná

ZIP/Postal Code

81520-060

Country

Brazil

Facility Name

Novartis Investigative Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Novartis Investigative Site

City

Florianopolis

State/Province

Santa Catarina

ZIP/Postal Code

88034-000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

São Paulo

ZIP/Postal Code

01236030

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

São Paulo

ZIP/Postal Code

08270-070

Country

Brazil

Facility Name

Novartis Investigative Site

City

Rio de Janeiro

ZIP/Postal Code

20211-030

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo - SP

ZIP/Postal Code

01323-900

Country

Brazil

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

Novartis Investigative Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Facility Name

Novartis Investigative Site

City

Québec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Facility Name

Novartis Investigative Site

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Ostrava

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha

ZIP/Postal Code

128 20

Country

Czechia

Facility Name

Novartis Investigative Site

City

Aarhus

ZIP/Postal Code

8000 C

Country

Denmark

Facility Name

Novartis Investigative Site

City

Koebenhavn Oe

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Novartis Investigative Site

City

Angers Cedex 9

ZIP/Postal Code

49933

Country

France

Facility Name

Novartis Investigative Site

City

Caen Cedex 9

ZIP/Postal Code

14033

Country

France

Facility Name

Novartis Investigative Site

City

Le Mans

ZIP/Postal Code

72000

Country

France

Facility Name

Novartis Investigative Site

City

Paris Cedex 12

ZIP/Postal Code

75571

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Novartis Investigative Site

City

Pringy Cedex

ZIP/Postal Code

74374

Country

France

Facility Name

Novartis Investigative Site

City

Stuttgart

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

70199

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

81675

Country

Germany

Facility Name

Novartis Investigative Site

City

Goettingen

State/Province

Niedersachsen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Novartis Investigative Site

City

Duesseldorf

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

40225

Country

Germany

Facility Name

Novartis Investigative Site

City

Duesseldorf

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

40479

Country

Germany

Facility Name

Novartis Investigative Site

City

Duisburg

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

47166

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens,

ZIP/Postal Code

11 527

Country

Greece

Facility Name

Novartis Investigative Site

City

Larisa

ZIP/Postal Code

41 110

Country

Greece

Facility Name

Novartis Investigative Site

City

Patra

ZIP/Postal Code

26500

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

54636

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

54642

Country

Greece

Facility Name

Novartis Investigative Site

City

Chai Wan

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Hong Kong

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Shatin, New Territories

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Tuen Mun

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4012

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Novartis Investigative Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Novartis Investigative Site

City

Galway

Country

Ireland

Facility Name

Novartis Investigative Site

City

James Street

ZIP/Postal Code

Country

Ireland

Facility Name

Novartis Investigative Site

City

Limerick

Country

Ireland

Facility Name

Novartis Investigative Site

City

Tallaght, Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Novartis Investigative Site

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Novartis Investigative Site

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Novartis Investigative Site

City

Petach-Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Novartis Investigative Site

City

Reggio Calabria

State/Province

Calabria

ZIP/Postal Code

89100

Country

Italy

Facility Name

Novartis Investigative Site

City

Modena

State/Province

Emilia-Romagna

ZIP/Postal Code

41124

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

State/Province

Liguria

ZIP/Postal Code

10126

Country

Italy

Facility Name

Novartis Investigative Site

City

Novara

State/Province

Piemonte

ZIP/Postal Code

28100

Country

Italy

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

Toscana

ZIP/Postal Code

50134

Country

Italy

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Novartis Investigative Site

City

Oaxaca

ZIP/Postal Code

68000

Country

Mexico

Facility Name

Novartis Investigative Site

City

Bergen

ZIP/Postal Code

N-5021

Country

Norway

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

0027

Country

Norway

Facility Name

Novartis Investigative Site

City

Lima

ZIP/Postal Code

Lima 11

Country

Peru

Facility Name

Novartis Investigative Site

City

Lima

ZIP/Postal Code

Lima 31

Country

Peru

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Novartis Investigative Site

City

Legnica

ZIP/Postal Code

59-200

Country

Poland

Facility Name

Novartis Investigative Site

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

Facility Name

Novartis Investigative Site

City

Opole

ZIP/Postal Code

45-061

Country

Poland

Facility Name

Novartis Investigative Site

City

Slupsk

ZIP/Postal Code

76-200

Country

Poland

Facility Name

Novartis Investigative Site

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Novartis Investigative Site

City

San Juan

ZIP/Postal Code

00927

Country

Puerto Rico

Facility Name

Novartis Investigative Site

City

Kaluga

ZIP/Postal Code

248007

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

125167

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

129301

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Penza

ZIP/Postal Code

440071

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

193024

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St'Petersburg

ZIP/Postal Code

197341

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33011

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Gerona

ZIP/Postal Code

17007

Country

Spain

Facility Name

Novartis Investigative Site

City

La Laguna (Santa Cruz De Tenerife)

ZIP/Postal Code

38320

Country

Spain

Facility Name

Novartis Investigative Site

City

Leon

ZIP/Postal Code

24071

Country

Spain

Facility Name

Novartis Investigative Site

City

León

ZIP/Postal Code

24071

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Novartis Investigative Site

City

Majadahonda (Madrid)

ZIP/Postal Code

28222

Country

Spain

Facility Name

Novartis Investigative Site

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Oviedo

ZIP/Postal Code

33006

Country

Spain

Facility Name

Novartis Investigative Site

City

Palma de Mallorca

ZIP/Postal Code

07014

Country

Spain

Facility Name

Novartis Investigative Site

City

Palma de Mallorca

ZIP/Postal Code

07198

Country

Spain

Facility Name

Novartis Investigative Site

City

Pozuelo De Alarcon/Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

Novartis Investigative Site

City

Pozuelo De Alarcón/Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

Novartis Investigative Site

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Novartis Investigative Site

City

Goteborg

ZIP/Postal Code

SE-413 45

Country

Sweden

Facility Name

Novartis Investigative Site

City

Göteborg

ZIP/Postal Code

SE-413 45

Country

Sweden

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

SE-141 86

Country

Sweden

Facility Name

Novartis Investigative Site

City

Uppsala

ZIP/Postal Code

SE-751 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Aarau

ZIP/Postal Code

5001

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Bellinzona

ZIP/Postal Code

6500

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Zuerich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Kaohsiung

ZIP/Postal Code

833

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Novartis Investigative Site

City

ChiangMai

ZIP/Postal Code

50000

Country

Thailand

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06590

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Novartis Investigative Site

City

Samsun

ZIP/Postal Code

55139

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

30305280

Citation

Dickinson M, Cherif H, Fenaux P, Mittelman M, Verma A, Portella MSO, Burgess P, Ramos PM, Choi J, Platzbecker U; SUPPORT study investigators. Azacitidine with or without eltrombopag for first-line treatment of intermediate- or high-risk MDS with thrombocytopenia. Blood. 2018 Dec 20;132(25):2629-2638. doi: 10.1182/blood-2018-06-855221. Epub 2018 Oct 10.

Results Reference

derived

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A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS)

Thrombocytopaenia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial