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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hematopoietic Neoplasm

Thank you

Trial Information

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


The expected duration of the 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
EOT visit for subjects who will not continue the treatment after completing the 6 cycles of
SAR302503, or discontinue the treatment early for any reasons as well as a follow-up visit
which should occur 30 days after the last administration of SAR302503. Patients who continue
to benefit clinically will be allowed to remain on study medication beyond the 6-month
treatment period until the occurrence of disease progression or unacceptable toxicity.

Inclusion Criteria


Inclusion criteria:

- 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

Exclusion criteria:

- 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:

- 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

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 x ULN

- Total 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

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:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

ARD12181

NCT ID:

NCT01523171

Start Date:

April 2012

Completion Date:

September 2019

Related Keywords:

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

Name

Location

Investigational Site Number 840011Kettering, Ohio  45429
Investigational Site Number 840004Santa Monica, California  90403
Investigational Site Number 840003San Diego, California  92123
Investigational Site Number 840005Savannah, Georgia  31403
Investigational Site Number 840009Valhalla, New York  10595
Investigational Site Number 840010Ann Arbor, Michigan  48109
Investigational Site Number 840002Houston, Texas  77030
Investigational Site Number 840007Casa Grande, Arizona  85222
Investigational Site Number 840022Sylvania, Ohio  43560
Investigational Site Number 840014Chicago, Illinois  60637
Investigational Site Number 840001Kansas City, Kansas  66160-7321
Investigational Site Number 840013Baltimore, Maryland  21229
Investigational Site Number 840017Baltimore, Maryland  21201
Investigational Site Number 840019Middletown, Ohio  45042
Investigational Site Number 840023San Antonio, Texas  78229
Investigational Site Number 840015Salt Lake City, Utah  84112-5550