- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01437787
Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis (JAKARTA)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
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Box Hill, Australien, 3128
- Investigational Site Number 036001
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Herston, Australien, 4029
- Investigational Site Number 036005
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Randwick, Australien, 2031
- Investigational Site Number 036003
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Tweed Heads, Australien, 2485
- Investigational Site Number 036004
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Wodonga, Australien, 3690
- Investigational Site Number 036002
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Antwerpen, Belgien, 2060
- Investigational Site Number 056003
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Leuven, Belgien, 3000
- Investigational Site Number 056001
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Jau, Brasilien, 17210-120
- Investigational Site Number 076002
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Porto Alegre, Brasilien, 90110-270
- Investigational Site Number 076004
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Rio De Janeiro, Brasilien, 20230-130
- Investigational Site Number 076001
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Marseille, Frankrike, 13273
- Investigational Site Number 250006
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Nantes Cedex 01, Frankrike, 44093
- Investigational Site Number 250005
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Nimes, Frankrike, 30029
- Investigational Site Number 250004
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Pierre Benite Cedex, Frankrike, 69495
- Investigational Site Number 250002
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Poitiers, Frankrike, 86000
- Investigational Site Number 250007
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Toulouse, Frankrike, 31000
- Investigational Site Number 250003
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Villejuif Cedex, Frankrike, 94805
- Investigational Site Number 250001
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Arizona
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Scottsdale, Arizona, Förenta staterna, 85259-5499
- Investigational Site Number 840014
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California
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La Jolla, California, Förenta staterna, 92093
- Investigational Site Number 840001
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La Jolla, California, Förenta staterna, 92093
- Investigational Site Number 840012
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Los Angeles, California, Förenta staterna, 90033
- Investigational Site Number 840006
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Louisiana
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Baton Rouge, Louisiana, Förenta staterna, 70808
- Investigational Site Number 840013
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Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Investigational Site Number 840008
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New Jersey
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Newark, New Jersey, Förenta staterna, 07112
- Investigational Site Number 840009
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Ohio
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Canton, Ohio, Förenta staterna, 44718
- Investigational Site Number 840002
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Texas
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Houston, Texas, Förenta staterna, 77030
- Investigational Site Number 840004
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Dublin, Irland, DUBLIN 8
- Investigational Site Number 372002
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Galway, Irland
- Investigational Site Number 372001
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Haifa, Israel, 31048
- Investigational Site Number 376003
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Tel Hashomer, Israel, 52621
- Investigational Site Number 376002
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Bergamo, Italien, 24127
- Investigational Site Number 380002
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Bologna, Italien, 40138
- Investigational Site Number 380007
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Firenze, Italien, 50134
- Investigational Site Number 380004
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Pavia, Italien, 27100
- Investigational Site Number 380001
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Pavia, Italien, 27100
- Investigational Site Number 380006
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Varese, Italien, 21100
- Investigational Site Number 380003
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Montreal, Kanada, H1T 2M4
- Investigational Site Number 124001
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Montreal, Kanada, H2W 1S6
- Investigational Site Number 124003
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Saint John, Kanada, E2L 4L2
- Investigational Site Number 124002
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Bundang-Gu, Korea, Republiken av, 463-707
- Investigational Site Number 410002
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Seoul, Korea, Republiken av, 110-744
- Investigational Site Number 410004
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Seoul, Korea, Republiken av, 135-710
- Investigational Site Number 410001
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Seoul, Korea, Republiken av, 120-752
- Investigational Site Number 410003
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Seoul, Korea, Republiken av, 137-701
- Investigational Site Number 410005
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Seoul, Korea, Republiken av, 138-878
- Investigational Site Number 410006
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Seoul, Korea, Republiken av
- Investigational Site Number 410007
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Kaunas, Litauen, LT-50009
- Investigational Site Number 440001
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Klaipeda, Litauen, LT-92288
- Investigational Site Number 440002
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Queretaro, Mexiko, 76000
- Investigational Site Number 484001
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Brzozow, Polen, 36-200
- Investigational Site Number 616005
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Gdansk, Polen, 80-952
- Investigational Site Number 616002
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Lodz, Polen, 93-510
- Investigational Site Number 616006
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Warszawa, Polen, 02-106
- Investigational Site Number 616010
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Wroclaw, Polen, 50-367
- Investigational Site Number 616003
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Coimbra, Portugal, 3000-075
- Investigational Site Number 620005
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Lisboa, Portugal, 1649-035
- Investigational Site Number 620001
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Lisboa, Portugal, 1169-050
- Investigational Site Number 620004
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Porto, Portugal, 4200-072
- Investigational Site Number 620003
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Brasov, Rumänien
- Investigational Site Number 642003
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Bucharest, Rumänien, 022328
- Investigational Site Number 642004
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Bucuresti, Rumänien, 030171
- Investigational Site Number 642002
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Bucuresti, Rumänien
- Investigational Site Number 642006
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Timisoara, Rumänien
- Investigational Site Number 642001
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Moscow, Ryska Federationen, 125167
- Investigational Site Number 643009
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Moscow, Ryska Federationen, 125284
- Investigational Site Number 643001
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Nizhny Novgorod, Ryska Federationen, 603126
- Investigational Site Number 643010
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Petrozavodsk, Ryska Federationen, 185019
- Investigational Site Number 643008
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St-Petersburg, Ryska Federationen, 197341
- Investigational Site Number 643004
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St.-Petersburg, Ryska Federationen, 191024
- Investigational Site Number 643005
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Volgograd, Ryska Federationen, 400138
- Investigational Site Number 643007
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Singapore, Singapore, 119228
- Investigational Site Number 702002
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Singapore, Singapore, 169608
- Investigational Site Number 702001
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Barcelona, Spanien, 08036
- Investigational Site Number 724001
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Madrid, Spanien, 28046
- Investigational Site Number 724002
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Belfast, Storbritannien, BT9 7AB
- Investigational Site Number 826006
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Birmingham, Storbritannien, B9 5SS
- Investigational Site Number 826003
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Glasgow, Storbritannien, G12 0YN
- Investigational Site Number 826002
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Leeds, Storbritannien, LS9 7TF
- Investigational Site Number 826004
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London, Storbritannien, SE1 9RT
- Investigational Site Number 826001
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London, Storbritannien, W12 0HS
- Investigational Site Number 826005
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Manchester, Storbritannien, M20 4BX
- Investigational Site Number 826007
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Newcastle Upon Tyne, Storbritannien, NE7 7DN
- Investigational Site Number 826008
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Oxford, Storbritannien, OX3 7LJ
- Investigational Site Number 826009
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Southampton, Storbritannien, SO16 6YD
- Investigational Site Number 826010
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Stockholm, Sverige, 14186
- Investigational Site Number 752001
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Uddevalla, Sverige, 451 80
- Investigational Site Number 752002
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Johannesburg, Sydafrika, 2013
- Investigational Site Number 710003
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Parktown, Sydafrika, 2193
- Investigational Site Number 710002
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Changhua, Taiwan, 500
- Investigational Site Number 158002
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Kaohsiung, Taiwan, 833
- Investigational Site Number 158003
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Taipei, Taiwan, 112
- Investigational Site Number 158001
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Aachen, Tyskland, 52074
- Investigational Site Number 276006
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Bonn, Tyskland, 53127
- Investigational Site Number 276007
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Dresden, Tyskland, 01307
- Investigational Site Number 276008
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Mannheim, Tyskland, 68167
- Investigational Site Number 276001
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Budapest, Ungern, 1097
- Investigational Site Number 348002
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Debrecen, Ungern, 4032
- Investigational Site Number 348001
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Györ, Ungern, 9023
- Investigational Site Number 348007
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Kecskemét, Ungern, 6000
- Investigational Site Number 348006
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Miskolc, Ungern, 3529
- Investigational Site Number 348003
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Wien, Österrike, 1090
- Investigational Site Number 040001
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Placebo-jämförare: Placebo comparator
once daily X 28 days, orally, empty stomach, approximately same time each day
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Pharmaceutical form:capsule Route of administration: oral |
Experimentell: SAR302503 400 mg
once daily X 28 days, orally, empty stomach, approximately same time each day
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Läkemedelsform: kapsel Administreringssätt: oralt |
Experimentell: SAR302503 500 mg
once daily X 28 days, orally, empty stomach, approximately same time each day
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Läkemedelsform: kapsel Administreringssätt: oralt |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
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
Tidsram: 6 months
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6 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Symptom Response Rate (SRR): Proportion of patients with ≥50% reduction from baseline to the end of Cycle 6 in the total symptom score.
Tidsram: 6 months
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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.
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6 months
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OS (overall survival) of either 400 mg/day or 500 mg/day of IMP as compared to placebo.
Tidsram: approximately 5 years
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approximately 5 years
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PFS (progression free survival) of either 400 mg/day or 500 mg/day of IMP as compared to placebo.
Tidsram: approximately 5 years
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approximately 5 years
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Proportion of patients who have ≥25% reduction in volume of spleen size at end of Cycle 6, and confirmed 4 weeks thereafter.
Tidsram: 6 months
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6 months
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Duration of spleen response, measured by MRI (or CT scan in patients with contraindications for MRI.
Tidsram: 2 years
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2 years
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Clinical and laboratory events graded by the NCI CTCAE v4.03.
Tidsram: approximately 5 years
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approximately 5 years
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- EFC12153
- 2011-001897-25 (EudraCT-nummer)
- U1111-1121-7170 (Annan identifierare: UTN)
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