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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Hematopoietic Neoplasm

Thank you

Trial Information

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


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.

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

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC12153

NCT ID:

NCT01437787

Start Date:

December 2011

Completion Date:

March 2016

Related Keywords:

  • Hematopoietic Neoplasm
  • Primary Myelofibrosis
  • Neoplasms
  • Thrombocythemia, Essential
  • Hematologic Neoplasms

Name

Location

Investigational Site Number 840006San Diego, California  92120
Investigational Site Number 840001Vallejo, California  94589
Investigational Site Number 840002Cincinnati, Ohio  45267-0542
Investigational Site Number 840012San Francisco, California  94143
Investigational Site Number 840014Scottsdale, Arizona  85259-5499
Investigational Site Number 840013Baton Rouge, Louisiana  70808
Investigational Site Number 840008Rochester, Minnesota  55905
Investigational Site Number 840009Newark, New Jersey  07112
Investigational Site Number 840004Houston, Texas  77030