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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01437787
Registration number
NCT01437787
Ethics application status
Date submitted
16/09/2011
Date registered
21/09/2011
Date last updated
8/01/2016
Titles & IDs
Public title
Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis
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Scientific title
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
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Secondary ID [1]
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2011-001897-25
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Secondary ID [2]
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EFC12153
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Universal Trial Number (UTN)
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Trial acronym
JAKARTA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hematopoietic Neoplasm
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Musculoskeletal
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Other muscular and skeletal disorders
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Human Genetics and Inherited Disorders
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SAR302503
Treatment: Drugs - Placebo
Placebo comparator: Placebo comparator - once daily X 28 days, orally, empty stomach, approximately same time each day
Experimental: SAR302503 400 mg - once daily X 28 days, orally, empty stomach, approximately same time each day
Experimental: SAR302503 500 mg - once daily X 28 days, orally, empty stomach, approximately same time each day
Treatment: Drugs: SAR302503
Pharmaceutical form:capsule
Route of administration: oral
Treatment: Drugs: Placebo
Pharmaceutical form:capsule
Route of administration: oral
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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6 months
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Secondary outcome [1]
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Symptom Response Rate (SRR): Proportion of patients with =50% reduction from baseline to the end of Cycle 6 in the total symptom score.
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Assessment method [1]
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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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Timepoint [1]
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6 months
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Secondary outcome [2]
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OS (overall survival) of either 400 mg/day or 500 mg/day of IMP as compared to placebo.
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Assessment method [2]
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Timepoint [2]
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approximately 5 years
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Secondary outcome [3]
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PFS (progression free survival) of either 400 mg/day or 500 mg/day of IMP as compared to placebo.
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Assessment method [3]
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Timepoint [3]
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approximately 5 years
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Secondary outcome [4]
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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.
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Assessment method [4]
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Timepoint [4]
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6 months
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Secondary outcome [5]
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Duration of spleen response, measured by MRI (or CT scan in patients with contraindications for MRI.
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Assessment method [5]
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Timepoint [5]
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2 years
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Secondary outcome [6]
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Clinical and laboratory events graded by the NCI CTCAE v4.03.
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Assessment method [6]
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Timepoint [6]
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approximately 5 years
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Eligibility
Key inclusion criteria
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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2014
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Sample size
Target
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Accrual to date
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Final
289
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigational Site Number 036001 - Box Hill
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Investigational Site Number 036005 - Herston
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Investigational Site Number 036003 - Randwick
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Investigational Site Number 036004 - Tweed Heads
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Investigational Site Number 036002 - Wodonga
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3128 - Box Hill
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4029 - Herston
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2031 - Randwick
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2485 - Tweed Heads
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3690 - Wodonga
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01437787
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Trial related presentations / publications
Pardanani A, Harrison C, Cortes JE, Cervantes F, Mesa RA, Milligan D, Masszi T, Mishchenko E, Jourdan E, Vannucchi AM, Drummond MW, Jurgutis M, Kuliczkowski K, Gheorghita E, Passamonti F, Neumann F, Patki A, Gao G, Tefferi A. Safety and Efficacy of Fedratinib in Patients With Primary or Secondary Myelofibrosis: A Randomized Clinical Trial. JAMA Oncol. 2015 Aug;1(5):643-51. doi: 10.1001/jamaoncol.2015.1590.
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Public notes
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Contacts
Principal investigator
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Clinical Sciences & Operations
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Sanofi
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01437787
Download to PDF