Deutsches Leukämie-Studienregister
Studie: JAKARTA2

Kurzübersicht
Öffentlicher Titel SAR302503 bei MF nach vorhergehender Behandlung mit Ruxolitinib
Wissenschaftl. Titel A Phase II, Multicenter, Open Label, Single Arm Study of SAR302503 in Subjects Previously Treated With Ruxolitinib and With a Current Diagnosis of Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
Kurztitel JAKARTA2
Studiennummer KN/ELN LN_NN_2012_522
Studiengruppe NN
Studienart multizentrisch, einarmig, prospektiv, offen
Studienphase Phase II
Erkrankung Myeloproliferative Neoplasien (MPN) - Myelofibrose
Leukämiestadium .
Ziele
  • To evaluate the efficacy of once daily dose of SAR302503 in subjects previously treated with ruxolitinib and with a current diagnosis of intermediate-1 with symptoms, Intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post-PV MF), or post-essential thrombocythemia myelofibrosis (Post-ET MF) based on the reduction of spleen volume at the end of 6 treatment cycles;
  • To evaluate the effect of SAR302503 on Myelofibrosis (MF) associated symptoms as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary
  • To evaluate the durability of splenic response
  • To evaluate the splenic response to SAR302503 by palpation at the end of Cycle 6
  • To evaluate the splenic response to SAR302503 at the end of Cycle 3
  • To evaluate the effect of SAR302503 on the Janus kinase 2 (JAK2) V617F allele burden
  • To evaluate the safety and tolerability of SAR302503 in this population
  • To evaluate plasma concentrations of SAR302503 for population PK analysis, if warranted
Einschlusskriterien
  • Diagnosis of PMF or Post-PV MF or Post-ET MF, according to the 2008 World Health Organization and IWG-MRT response criteria
  • Subjects who previously received Ruxolitinib treatment for PMF or Post-PV MF or Post-ET MF or PV or ET for at least 14 days (exposure of <14 days is allowed for subjects who discontinued Ruxolitinib due to intolerability or allergy) and discontinued the treatment for at least 14 days prior to the first dose of SAR302503
  • MF classified as Intermediate-1 with symptoms, Intermediate-2 or high-risk by Dynamic International Prognostic Scoring System (Passamonti et al., Blood 2010)
  • Spleen >=5 cm below costal margin as measured by palpation
  • Male and female subjects >=18 years of age
  • Signed written informed consent
Ausschlusskriterien
  • Splenectomy
  • Eastern Cooperative Oncology Group (ECOG) performance status of > 2 before the first dose of SAR302503 at Cycle 1 Day1
  • The following laboratory values within 14 days prior to the initiation of SAR302503:
  • a) Absolute Neutrophil Count (ANC) < 1.0 x10^9/L
  • b) Platelet count <50 x 10^9/L
  • c) Serum creatinine >1.5 x Upper limit of normal (ULN)
  • d) Serum amylase and lipase >1.5 x ULN
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >=2.5 x ULN
  • otal bilirubin >=3.0 x ULN
  • Subjects with total bilirubin between 1.5-3.0 x ULN must be excluded if the direct bilirubin fraction is >=25% of the total
  • Subjects with known active (acute or chronic) Hepatitis A, B, or C; and Hepatitis B and C carriers
  • Prior history of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis [NASH])
  • Subjects with any other prior malignancies are not eligible, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which subject has been disease-free for at least 5 years
  • Any chemotherapy, 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 SAR302503; darbepoetin use within 28 days prior to initiation of SAR302503.The only chemotherapy allowed will be hydroxyurea within 1 day prior to initiation of SAR302503
  • Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of SAR302503
  • ein Kriterium
Alter >= 18 Jahre
Status Aktiv
Beginn der Rekrutierung 01.04.2012
Rekrutierende Länder Deutschland
Frankreich
Großbritannien
Belgien
Spanien
Italien
Niederlande
U.S.A
Österreich
Canada
Studienleiter/in Reiter, Prof. Dr. med., Andreas
Kurzprotokoll Kurzprotokoll
Sponsoren Sanofi (Hauptsponsor)
Förderer Sanofi
Registrierung in anderen Studienregistern ClinicalTrials.gov NCT01523171 (primäres Register)
European Clinical Trials Database - EUDRACT 2011-005226-21
Haupt- und Nebenzielkriterien
  • Response Rate (RR), defined as the proportion of subjects who have a >= 35 % reduction from baseline in volume of spleen at the end of Cycle 6 as measured by Magnetic Resonance Imaging (MRI) (or CT scan in subjects with contraindications for MRI) [6 months] (Hauptzielkriterium)
  • Symptom Response Rate (SRR): Proportion of subjects with a >= 50 % reduction from baseline to the end of Cycle 6 in the total symptom score using the modified MFSAF [6 months]
  • Duration of spleen response, measured by MRI (or CT scan in subjects with contraindications for MRI) [6 months]
  • Proportion of subjects with a >= 50 % reduction in length of spleen by palpation from baseline at the end of Cycle 6 [6 months]
  • Response Rate at the end of Cycle 3, defined as the proportion of subjects who have a >= 35 % reduction from baseline in volume of spleen at the end of Cycle 3 as measured by MRI (or CT scan in subjects with contraindications for MRI) [6 months]
  • Percent change of spleen volume at the end of Cycles 3 and 6 from baseline as measured by MRI (or CT scan in subjects with contraindications for MRI) [6 months]
  • Safety, as assessed by clinical, laboratory, ECG, and vital sign events; graded by the NCI CTCAE v4.03 [pproximately 5 years]
  • Plasma concentrations of SAR302503 [4 months]
  • The effect of SAR302503 on the JAK2V617F allele burden [2 years]
erstellt 10.04.2013 Johannes Kraus
geändert 15.05.2013 Sina Hehn
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