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Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis (JAKARTA)

8. desember 2015 oppdatert av: Sanofi

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of SAR302503 in Patients With Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis With Splenomegaly

Primary Objective:

  • To evaluate the efficacy of daily oral doses of 400 mg or 500 mg of SAR302503 (Investigational Medicinal Product, IMP) compared to placebo in the reduction of spleen volume as determined by magnetic resonance imaging (MRI) (or computed tomography scan in patients with contraindications for MRI).

Secondary Objectives:

  • To evaluate the effect on Myelofibrosis (MF)-associated symptoms (key MF symptoms) as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary.
  • To evaluate the Overall Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo.
  • To evaluate the Progression Free Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo.
  • To evaluate the durability of splenic response.
  • To evaluate the safety of IMP.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The expected duration of a patient's treatment in this study is approximately 8 months, based on a maximum 28-day screening period, followed by a ≥6-month (6-cycle) treatment period, and an End Of Treatment (EOT) visit, which should be performed at least 30 days following the last administration of IMP or placebo.

Patients who continue to benefit clinically will be allowed to remain on IMP or placebo beyond the 6-month treatment period until the occurrence of disease progression or unacceptable toxicity.

Studietype

Intervensjonell

Registrering (Faktiske)

289

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
      • Box Hill, Australia, 3128
        • Investigational Site Number 036001
      • Herston, Australia, 4029
        • Investigational Site Number 036005
      • Randwick, Australia, 2031
        • Investigational Site Number 036003
      • Tweed Heads, Australia, 2485
        • Investigational Site Number 036004
      • Wodonga, Australia, 3690
        • Investigational Site Number 036002
  • Belgia
      • Antwerpen, Belgia, 2060
        • Investigational Site Number 056003
      • Leuven, Belgia, 3000
        • Investigational Site Number 056001
  • Brasil
      • Jau, Brasil, 17210-120
        • Investigational Site Number 076002
      • Porto Alegre, Brasil, 90110-270
        • Investigational Site Number 076004
      • Rio De Janeiro, Brasil, 20230-130
        • Investigational Site Number 076001
  • Canada
      • Montreal, Canada, H1T 2M4
        • Investigational Site Number 124001
      • Montreal, Canada, H2W 1S6
        • Investigational Site Number 124003
      • Saint John, Canada, E2L 4L2
        • Investigational Site Number 124002
  • Den russiske føderasjonen
      • Moscow, Den russiske føderasjonen, 125167
        • Investigational Site Number 643009
      • Moscow, Den russiske føderasjonen, 125284
        • Investigational Site Number 643001
      • Nizhny Novgorod, Den russiske føderasjonen, 603126
        • Investigational Site Number 643010
      • Petrozavodsk, Den russiske føderasjonen, 185019
        • Investigational Site Number 643008
      • St-Petersburg, Den russiske føderasjonen, 197341
        • Investigational Site Number 643004
      • St.-Petersburg, Den russiske føderasjonen, 191024
        • Investigational Site Number 643005
      • Volgograd, Den russiske føderasjonen, 400138
        • Investigational Site Number 643007
  • Forente stater
    • Arizona
      • Scottsdale, Arizona, Forente stater, 85259-5499
        • Investigational Site Number 840014
    • California
      • La Jolla, California, Forente stater, 92093
        • Investigational Site Number 840001
      • La Jolla, California, Forente stater, 92093
        • Investigational Site Number 840012
      • Los Angeles, California, Forente stater, 90033
        • Investigational Site Number 840006
    • Louisiana
      • Baton Rouge, Louisiana, Forente stater, 70808
        • Investigational Site Number 840013
    • Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Investigational Site Number 840008
    • New Jersey
      • Newark, New Jersey, Forente stater, 07112
        • Investigational Site Number 840009
    • Ohio
      • Canton, Ohio, Forente stater, 44718
        • Investigational Site Number 840002
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Investigational Site Number 840004
  • Frankrike
      • Marseille, Frankrike, 13273
        • Investigational Site Number 250006
      • Nantes Cedex 01, Frankrike, 44093
        • Investigational Site Number 250005
      • Nimes, Frankrike, 30029
        • Investigational Site Number 250004
      • Pierre Benite Cedex, Frankrike, 69495
        • Investigational Site Number 250002
      • Poitiers, Frankrike, 86000
        • Investigational Site Number 250007
      • Toulouse, Frankrike, 31000
        • Investigational Site Number 250003
      • Villejuif Cedex, Frankrike, 94805
        • Investigational Site Number 250001
  • Irland
      • Dublin, Irland, DUBLIN 8
        • Investigational Site Number 372002
      • Galway, Irland
        • Investigational Site Number 372001
  • Israel
      • Haifa, Israel, 31048
        • Investigational Site Number 376003
      • Tel Hashomer, Israel, 52621
        • Investigational Site Number 376002
  • Italia
      • Bergamo, Italia, 24127
        • Investigational Site Number 380002
      • Bologna, Italia, 40138
        • Investigational Site Number 380007
      • Firenze, Italia, 50134
        • Investigational Site Number 380004
      • Pavia, Italia, 27100
        • Investigational Site Number 380001
      • Pavia, Italia, 27100
        • Investigational Site Number 380006
      • Varese, Italia, 21100
        • Investigational Site Number 380003
  • Korea, Republikken
      • Bundang-Gu, Korea, Republikken, 463-707
        • Investigational Site Number 410002
      • Seoul, Korea, Republikken, 110-744
        • Investigational Site Number 410004
      • Seoul, Korea, Republikken, 135-710
        • Investigational Site Number 410001
      • Seoul, Korea, Republikken, 120-752
        • Investigational Site Number 410003
      • Seoul, Korea, Republikken, 137-701
        • Investigational Site Number 410005
      • Seoul, Korea, Republikken, 138-878
        • Investigational Site Number 410006
      • Seoul, Korea, Republikken
        • Investigational Site Number 410007
  • Litauen
      • Kaunas, Litauen, LT-50009
        • Investigational Site Number 440001
      • Klaipeda, Litauen, LT-92288
        • Investigational Site Number 440002
  • Mexico
      • Queretaro, Mexico, 76000
        • Investigational Site Number 484001
  • Polen
      • Brzozow, Polen, 36-200
        • Investigational Site Number 616005
      • Gdansk, Polen, 80-952
        • Investigational Site Number 616002
      • Lodz, Polen, 93-510
        • Investigational Site Number 616006
      • Warszawa, Polen, 02-106
        • Investigational Site Number 616010
      • Wroclaw, Polen, 50-367
        • Investigational Site Number 616003
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Investigational Site Number 620005
      • Lisboa, Portugal, 1649-035
        • Investigational Site Number 620001
      • Lisboa, Portugal, 1169-050
        • Investigational Site Number 620004
      • Porto, Portugal, 4200-072
        • Investigational Site Number 620003
  • Romania
      • Brasov, Romania
        • Investigational Site Number 642003
      • Bucharest, Romania, 022328
        • Investigational Site Number 642004
      • Bucuresti, Romania, 030171
        • Investigational Site Number 642002
      • Bucuresti, Romania
        • Investigational Site Number 642006
      • Timisoara, Romania
        • Investigational Site Number 642001
  • Singapore
      • Singapore, Singapore, 119228
        • Investigational Site Number 702002
      • Singapore, Singapore, 169608
        • Investigational Site Number 702001
  • Spania
      • Barcelona, Spania, 08036
        • Investigational Site Number 724001
      • Madrid, Spania, 28046
        • Investigational Site Number 724002
  • Storbritannia
      • Belfast, Storbritannia, BT9 7AB
        • Investigational Site Number 826006
      • Birmingham, Storbritannia, B9 5SS
        • Investigational Site Number 826003
      • Glasgow, Storbritannia, G12 0YN
        • Investigational Site Number 826002
      • Leeds, Storbritannia, LS9 7TF
        • Investigational Site Number 826004
      • London, Storbritannia, SE1 9RT
        • Investigational Site Number 826001
      • London, Storbritannia, W12 0HS
        • Investigational Site Number 826005
      • Manchester, Storbritannia, M20 4BX
        • Investigational Site Number 826007
      • Newcastle Upon Tyne, Storbritannia, NE7 7DN
        • Investigational Site Number 826008
      • Oxford, Storbritannia, OX3 7LJ
        • Investigational Site Number 826009
      • Southampton, Storbritannia, SO16 6YD
        • Investigational Site Number 826010
  • Sverige
      • Stockholm, Sverige, 14186
        • Investigational Site Number 752001
      • Uddevalla, Sverige, 451 80
        • Investigational Site Number 752002
  • Sør-Afrika
      • Johannesburg, Sør-Afrika, 2013
        • Investigational Site Number 710003
      • Parktown, Sør-Afrika, 2193
        • Investigational Site Number 710002
  • Taiwan
      • Changhua, Taiwan, 500
        • Investigational Site Number 158002
      • Kaohsiung, Taiwan, 833
        • Investigational Site Number 158003
      • Taipei, Taiwan, 112
        • Investigational Site Number 158001
  • Tyskland
      • Aachen, Tyskland, 52074
        • Investigational Site Number 276006
      • Bonn, Tyskland, 53127
        • Investigational Site Number 276007
      • Dresden, Tyskland, 01307
        • Investigational Site Number 276008
      • Mannheim, Tyskland, 68167
        • Investigational Site Number 276001
  • Ungarn
      • Budapest, Ungarn, 1097
        • Investigational Site Number 348002
      • Debrecen, Ungarn, 4032
        • Investigational Site Number 348001
      • Györ, Ungarn, 9023
        • Investigational Site Number 348007
      • Kecskemét, Ungarn, 6000
        • Investigational Site Number 348006
      • Miskolc, Ungarn, 3529
        • Investigational Site Number 348003
  • Østerrike
      • Wien, Østerrike, 1090
        • Investigational Site Number 040001

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion criteria:

  • Diagnosis of Primary Myelofibrosis (MF) or Post-Polycythemia Vera MF or Post-Essential Thrombocythemia MF, according to the 2008 World Health Organization and International Working Group of Myelofibrosis Research and Treatment (IWG-MRT) criteria.
  • MF classified as high-risk or intermediate-risk level 2, as defined by modified IWG-MRT criteria (IPSS) (according to Cervantes F. et. al.; at screening).
  • Enlarged spleen, palpable at least 5 cm below costal margin.
  • At least 18 years of age.
  • Eastern Cooperative Oncology Group performance status of 0, 1, or 2 at study entry.
  • The following laboratory values within 14 days prior to the initiation of IMP or placebo:
  • Absolute Neutrophil Count (ANC) ≥1.0 x 10exp9/L
  • Platelet count ≥50 x 10exp9/L
  • Serum creatinine ≤1.5 x Upper Limit of Normal (ULN)
  • Serum amylase and lipase ≤1.5 x ULN

Exclusion criteria:

  • Splenectomy.
  • Any chemotherapy (eg, hydroxyurea), immunomodulatory drug therapy (eg, thalidomide, interferon-alpha), Anagrelide, immunosuppressive therapy, corticosteroids >10 mg/day prednisone or equivalent, or growth factor treatment (eg, erythropoietin), or hormones (eg, androgens, danazol) within 14 days prior to initiation of IMP or placebo; darbepoetin use within 28 days prior to initiation of IMP or placebo. Patients who have had exposure to hydroxyurea (eg, hydrea) in the past may be enrolled into the study as long as it has not been administered within 14 days prior to initiation of IMP or placebo.
  • Major surgery within 28 days or radiation within 6 months prior to initiation of IMP or placebo.
  • Prior treatment with a Janus Kinase 2 (JAK2) inhibitor.
  • Known active (acute or chronic) Hepatitis A, B, or C; and hepatitis B and C carriers
  • AST or ALT ≥2.5 x ULN
  • Total Bilirubin:
  • Exclude if ≥3.0 x ULN
  • Patients with total bilirubin between 1.5-3.0 x ULN must be excluded if the direct bilirubin fraction is ≥25% of the total
  • Prior history of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis [NASH])

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo comparator
once daily X 28 days, orally, empty stomach, approximately same time each day
Legemiddel: Placebo

Pharmaceutical form:capsule

Route of administration: oral
Eksperimentell: SAR302503 400 mg
once daily X 28 days, orally, empty stomach, approximately same time each day
Legemiddel: SAR302503

Farmasøytisk form: kapsel

Administrasjonsvei: oral
Eksperimentell: SAR302503 500 mg
once daily X 28 days, orally, empty stomach, approximately same time each day
Legemiddel: SAR302503

Farmasøytisk form: kapsel

Administrasjonsvei: oral

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Response Rate (RR), defined as the proportion of patients who have a ≥35% reduction in volume of spleen size at the end of Cycle 6, and confirmed 4 weeks thereafter
Tidsramme: 6 months
6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Symptom Response Rate (SRR): Proportion of patients with ≥50% reduction from baseline to the end of Cycle 6 in the total symptom score.
Tidsramme: 6 months
This assessment will be conducted through the modified MFSAF diary, which will be completed during the week prior to Day 1 of each treatment cycle up to Cycle 6, and during the week prior to the end of Cycle 6.
6 months
OS (overall survival) of either 400 mg/day or 500 mg/day of IMP as compared to placebo.
Tidsramme: approximately 5 years
approximately 5 years
PFS (progression free survival) of either 400 mg/day or 500 mg/day of IMP as compared to placebo.
Tidsramme: approximately 5 years
approximately 5 years
Proportion of patients who have ≥25% reduction in volume of spleen size at end of Cycle 6, and confirmed 4 weeks thereafter.
Tidsramme: 6 months
6 months
Duration of spleen response, measured by MRI (or CT scan in patients with contraindications for MRI.
Tidsramme: 2 years
2 years
Clinical and laboratory events graded by the NCI CTCAE v4.03.
Tidsramme: approximately 5 years
approximately 5 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sanofi

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2011

Primær fullføring (Faktiske)

1. juni 2014

Studiet fullført (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først innsendt

16. september 2011

Først innsendt som oppfylte QC-kriteriene

20. september 2011

Først lagt ut (Anslag)

21. september 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

8. januar 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. desember 2015

Sist bekreftet

1. desember 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EFC12153
  • 2011-001897-25 (EudraCT-nummer)
  • U1111-1121-7170 (Annen identifikator: UTN)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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