AzTrials
AzTrials

ThrombocytopaeniaPhase 3NCT02158936

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)

A Phase 3 study testing Eltrombopag and Azacitidine in people with Thrombocytopaenia, run by Novartis Pharmaceuticals at 155 sites in 30 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thrombocytopaenia
What is being tested?
Eltrombopag and Azacitidine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
356 participants
Where
155 sitesin 30 countries
Study dates
10 Jun 2014to 30 Apr 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

155 sites in 30 countries.

155 sites in 30 countries

Spain19 sites

  • Novartis Investigative Site

    Barcelona, 08035

  • Novartis Investigative Site

    Barcelona, 08036

  • Novartis Investigative Site

    Girona, 17007

  • Novartis Investigative Site

    La Laguna (Santa Cruz de Tenerife), 38320

  • Novartis Investigative Site

    León, 24071

  • Novartis Investigative Site

    Madrid, 28007

  • Novartis Investigative Site

    Madrid, 28034

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Majadahonda (Madrid), 28222

  • Novartis Investigative Site

    Málaga, 29010

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33011

  • Novartis Investigative Site

    Oviedo, 33006

  • Novartis Investigative Site

    Palma de Mallorca, 07014

  • Novartis Investigative Site

    Palma de Mallorca, 07198

  • Novartis Investigative Site

    Pozuelo de Alarcon/Madrid, 28223

  • Novartis Investigative Site

    Pozuelo de Alarcón/Madrid, 28223

  • Novartis Investigative Site

    Salamanca, 37007

  • Novartis Investigative Site

    Valencia, 46010

  • Novartis Investigative Site

    Valencia, 46026

Other trials in Spain

United States10 sites

  • Novartis Investigative Site

    Anderson, Indiana, 46016

  • Novartis Investigative Site

    Atlanta, Georgia, 30322

  • Novartis Investigative Site

    Chicago, Illinois, 60612

  • Novartis Investigative Site

    Hartford, Connecticut, 06105

  • Novartis Investigative Site

    Kansas City, Missouri, 64128

  • Novartis Investigative Site

    Milwaukee, Wisconsin, 53226

  • Novartis Investigative Site

    Seattle, Washington, 98108

  • Novartis Investigative Site

    St Louis, Missouri, 63110

  • Novartis Investigative Site

    The Bronx, New York, 10461

  • Novartis Investigative Site

    Winston-Salem, North Carolina, 27157

Other trials in United States

Brazil8 sites

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30130-100

  • Novartis Investigative Site

    Curitiba, Paraná, 81520-060

  • Novartis Investigative Site

    Florianópolis, Santa Catarina, 88034-000

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Novartis Investigative Site

    Rio de Janeiro, 20211-030

  • Novartis Investigative Site

    São Paulo, São Paulo, 01236030

  • Novartis Investigative Site

    São Paulo, São Paulo, 08270-070

  • Novartis Investigative Site

    Sao Paulo - SP, 01323-900

Other trials in Brazil

Austria7 sites

  • Novartis Investigative Site

    Graz, 8036

  • Novartis Investigative Site

    Innsbruck, A-6020

  • Novartis Investigative Site

    Linz, 4020

  • Novartis Investigative Site

    Rankweil, A-6830

  • Novartis Investigative Site

    Salzburg, A-5020

  • Novartis Investigative Site

    Steyr, 4400

  • Novartis Investigative Site

    Vienna, 1140

Other trials in Austria

Germany7 sites

  • Novartis Investigative Site

    Dresden, Saxony, 01307

  • Novartis Investigative Site

    Duisburg, North Rhine-Westphalia, 47166

  • Novartis Investigative Site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Novartis Investigative Site

    Düsseldorf, North Rhine-Westphalia, 40479

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37075

  • Novartis Investigative Site

    Munich, Bavaria, 81675

  • Novartis Investigative Site

    Stuttgart, Baden-Wurttemberg, 70199

Other trials in Germany

Israel7 sites

  • Novartis Investigative Site

    Haifa, 31096

  • Novartis Investigative Site

    Holon, 58100

  • Novartis Investigative Site

    Jerusalem, 91031

  • Novartis Investigative Site

    Jerusalem, 91120

  • Novartis Investigative Site

    Kfar Saba, 44281

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Tel Aviv, 64239

Other trials in Israel

Russia7 sites

  • Novartis Investigative Site

    Kaluga, 248007

  • Novartis Investigative Site

    Moscow, 115478

  • Novartis Investigative Site

    Moscow, 125167

  • Novartis Investigative Site

    Moscow, 129301

  • Novartis Investigative Site

    Penza, 440071

  • Novartis Investigative Site

    Saint Petersburg, 193024

  • Novartis Investigative Site

    St'Petersburg, 197341

Other trials in Russia

France6 sites

  • Novartis Investigative Site

    Angers, 49933

  • Novartis Investigative Site

    Caen, 14033

  • Novartis Investigative Site

    Le Mans, 72000

  • Novartis Investigative Site

    Paris, 75010

  • Novartis Investigative Site

    Paris, 75571

  • Novartis Investigative Site

    Pringy, 74374

Other trials in France

Poland6 sites

  • Novartis Investigative Site

    Krakow, 31-501

  • Novartis Investigative Site

    Legnica, 59-200

  • Novartis Investigative Site

    Lublin, 20-081

  • Novartis Investigative Site

    Opole, 45-061

  • Novartis Investigative Site

    Słupsk, 76-200

  • Novartis Investigative Site

    Torun, 87-100

Other trials in Poland

South Korea6 sites

  • Novartis Investigative Site

    Seoul, 05505

  • Novartis Investigative Site

    Seoul, 06351

  • Novartis Investigative Site

    Seoul, 06591

  • Novartis Investigative Site

    Seoul, 135-710

  • Novartis Investigative Site

    Seoul, 137-701

  • Novartis Investigative Site

    Seoul, 138-736

Other trials in South Korea

Australia5 sites

  • Novartis Investigative Site

    Adelaide, South Australia, 5000

  • Novartis Investigative Site

    Clayton, Victoria, 3168

  • Novartis Investigative Site

    East Melbourne, Victoria, 3002

  • Novartis Investigative Site

    Kogarah, New South Wales, 2217

  • Novartis Investigative Site

    Melbourne, Victoria, 3000

Other trials in Australia

Belgium5 sites

  • Novartis Investigative Site

    Brasschaat, 2930

  • Novartis Investigative Site

    Bruges, 8000

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Lodelinsart, 6042

  • Novartis Investigative Site

    Turnhout, 2300

Other trials in Belgium

Canada5 sites

  • Novartis Investigative Site

    Montreal, Quebec, H2L 4M1

  • Novartis Investigative Site

    Québec, Quebec, G1J 1Z4

  • Novartis Investigative Site

    Québec, G1J 1Z4

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1H 5N4

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Czechia5 sites

  • Novartis Investigative Site

    Brno, 625 00

  • Novartis Investigative Site

    Ostrava, 708 52

  • Novartis Investigative Site

    Prague, 100 34

  • Novartis Investigative Site

    Prague, 128 08

  • Novartis Investigative Site

    Prague, 128 20

Other trials in Czechia

Greece5 sites

  • Novartis Investigative Site

    Athens, 11 527

  • Novartis Investigative Site

    Larissa, 41 110

  • Novartis Investigative Site

    Pátrai, 26500

  • Novartis Investigative Site

    Thessaloniki, 54636

  • Novartis Investigative Site

    Thessaloniki, 54642

Other trials in Greece

Ireland5 sites

  • Novartis Investigative Site

    Dublin, 7

  • Novartis Investigative Site

    Galway

  • Novartis Investigative Site

    James Street, 8

  • Novartis Investigative Site

    Limerick

  • Novartis Investigative Site

    Tallaght, Dublin, 24

Other trials in Ireland

Italy5 sites

  • Novartis Investigative Site

    Florence, Tuscany, 50134

  • Novartis Investigative Site

    Genoa, Liguria, 10126

  • Novartis Investigative Site

    Modena, Emilia-Romagna, 41124

  • Novartis Investigative Site

    Novara, Piedmont, 28100

  • Novartis Investigative Site

    Reggio Calabria, Calabria, 89100

Other trials in Italy

Argentina4 sites

  • Novartis Investigative Site

    Buenos Aires, 1114

  • Novartis Investigative Site

    Buenos Aires, 1425

  • Novartis Investigative Site

    Buenos Aires, C1181ACH

  • Novartis Investigative Site

    Santa Fe, S3000ADL

Other trials in Argentina

Hong Kong4 sites

  • Novartis Investigative Site

    Chai Wan

  • Novartis Investigative Site

    Hong Kong

  • Novartis Investigative Site

    Shatin, New Territories

  • Novartis Investigative Site

    Tuenmen

Other trials in Hong Kong

Switzerland4 sites

  • Novartis Investigative Site

    Aarau, 5001

  • Novartis Investigative Site

    Bellinzona, 6500

  • Novartis Investigative Site

    Bern, 3010

  • Novartis Investigative Site

    Zurich, 8091

Other trials in Switzerland

Taiwan4 sites

  • Novartis Investigative Site

    Changhua, 500

  • Novartis Investigative Site

    Kaohsiung City, 807

  • Novartis Investigative Site

    Kaohsiung City, 833

  • Novartis Investigative Site

    Taipei, 112

Other trials in Taiwan

Turkey (Türkiye)4 sites

  • Novartis Investigative Site

    Ankara, 06590

  • Novartis Investigative Site

    Izmir, 35100

  • Novartis Investigative Site

    Izmir, 35340

  • Novartis Investigative Site

    Samsun, 55139

Other trials in Turkey (Türkiye)

Sweden3 sites

  • Novartis Investigative Site

    Gothenburg, SE-413 45

  • Novartis Investigative Site

    Stockholm, SE-141 86

  • Novartis Investigative Site

    Uppsala, SE-751 85

Other trials in Sweden

Thailand3 sites

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Bangkok, 10700

  • Novartis Investigative Site

    Chiang Mai, 50000

Other trials in Thailand

Denmark2 sites

  • Novartis Investigative Site

    Aarhus, 8000 C

  • Novartis Investigative Site

    Koebenhavn Oe, 2100

Other trials in Denmark

Hungary2 sites

  • Novartis Investigative Site

    Debrecen, 4012

  • Novartis Investigative Site

    Szeged, 6725

Other trials in Hungary

Mexico2 sites

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64460

  • Novartis Investigative Site

    Oaxaca City, 68000

Other trials in Mexico

Norway2 sites

  • Novartis Investigative Site

    Bergen, N-5021

  • Novartis Investigative Site

    Oslo, 0027

Other trials in Norway

Peru2 sites

  • Novartis Investigative Site

    Lima, Lima 11

  • Novartis Investigative Site

    Lima, Lima 31

Other trials in Peru

Puerto Rico1 site

  • Novartis Investigative Site

    San Juan, 00927

Other trials in Puerto Rico

About this study

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

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.

Being tested
Eltrombopag, Azacitidine, Placebo
Keywords
thrombocytopenia, myelodysplastic syndromes, MDS, thrombopoietin, azacitidine, Eltrombopag, myelodysplastic syndromes (MDS)
Medical subject headings
Thrombocytopenia, Myelodysplastic Syndromes, Jacobs syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EltrombopagDrug

    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

  • AzacitidineDrug

    Subcutaneous Injection (IV if local standard)

  • PlaceboDrug

    Eltrombopag matching placebo tablets

  • PlaceboDrug

    Eltrombopag matching placebo tablets will be supplied

Study groups in NCT02158936
Study groupRoleWhat they receive
EltrombopagExperimentalEligible 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
Receives: Drug: Eltrombopag; Drug: Azacitidine
PlaceboPlacebo comparatorEligible 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
Receives: Drug: Azacitidine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 4 cycles (Cycle = 28 days)

Secondary outcomes (19)

  1. 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

    Measured: Randomization until death or end of study, approximately 2 years

  2. 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

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

  3. Summary of Progression Free Survival From Central Review (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

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

  4. 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

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

  5. 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

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

  6. Best Disease Response From Central Review (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

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

  7. 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

    Measured: 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)

  8. 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

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

  9. 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

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

  10. 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

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

  11. 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

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

  12. 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.)

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

  13. 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

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

  14. 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

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

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

    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

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

  16. 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)

    Measured: 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

  17. Summary of Post-Hoc Estimates of Steady-state Eltrombopag AUC0 Infinity 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)

    Measured: 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

  18. 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.

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

  19. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2014 (estimated)
  2. Study start10 Jun 2014
  3. Primary completion30 Apr 2016
  4. Study completion30 Apr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
356 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02158936
Sponsor's protocol ID
112121
Status last verified
Sep 2017
First submitted
5 Jun 2014
Last updated
12 Dec 2017
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 30305280

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eltrombopag and Azacitidine in people with Thrombocytopaenia, run by Novartis Pharmaceuticals at 155 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 155 sites in Spain, United States, Brazil, Austria, Germany and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Were Platelet Transfusion Independent During Cycles 1-4 of Azacitidine Therapy (time frame: 4 cycles (Cycle = 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02158936, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.

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