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A UK Open-label, Multicentre, Exploratory Phase II Study of INC424 for Patients With Primary Myelofibrosis (PMF) or Post Polycythaemia Myelofibrosis (PPV MF) or Post Essential Thrombocythaemia Myelofibrosis (PET-MF)


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Primary Myelofibrosis (PMF), Post Polycythaemia Myelofibrosis (PPV MF), Post Essential Thrombocythaemia Myelofibrosis (PET-MF)

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Trial Information

A UK Open-label, Multicentre, Exploratory Phase II Study of INC424 for Patients With Primary Myelofibrosis (PMF) or Post Polycythaemia Myelofibrosis (PPV MF) or Post Essential Thrombocythaemia Myelofibrosis (PET-MF)


Inclusion Criteria:



- Patients must not be eligible for another ongoing INC424 clinical trial.

- Patients must be diagnosed with PMF, PPV MF or PET-MF, according to the 2008 revised
World Health Organization criteria irrespective of JAK2 mutation status.

- Patients with PMF requiring therapy must be classified as high risk (3 prognostic
factors) OR intermediate risk level 2 (2 prognostic factors, no more), OR
intermediate risk level 1 (1 prognostic factor, no more) with an enlarged spleen.
The prognostic factors, defined by the International Working Group are:

1. Age > 65 years;

2. Presence of constitutional symptoms (weight loss, fever, night sweats); marked
anemia (Hgb < 10g/dL)*;

3. Leukocytosis (history of WBC > 25 x109/L);

4. Circulating blasts > 1%. • A hemoglobin value < 10 g/dL must be demonstrated
during the Screening Visit for patients who are not transfusion dependent.
Patients receiving regular transfusions of packed red blood cells will be
considered to have hemoglobin < 10 g/dL for the purpose of evaluation of risk
factors.

- Patients with Intermediate-1 disease and splenomegaly must have a palpable spleen
measuring 5 cm or greater from the costal margin to the point of greatest splenic
protrusion.

- Patients must have a peripheral blood blast count of < 10%.

- Patients with adequate liver function defined as direct bilirubin ≤ 2.0 x ULN and ALT
≤ 2.5 x ULN.

- Patients with adequate renal function defined as serum creatinine ≤ 2 x ULN.

- Patients with an ECOG performance status of 0, 1, or 2 (Appendix 5).

Exclusion criteria:

- Patients eligible for hematopoietic stem cell transplantation (suitable candidate and
a suitable donor is available).

- Patients with history of malignancy in past 3 years except for treated, early-stage
squamous or basal cell carcinoma in situ.

- Patients undergoing treatment with hematopoietic growth factor receptor agonists
(i.e., erythropoietin [Epo], granulocyte colony stimulating factor (GCSF [Neupogen;
Neulasta], romiplostim, eltrombopag) at any time within 2 weeks prior to Screening or
4 weeks prior to Baseline.

- Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of oral INC424 (e.g., ulcerative diseases, uncontrolled nausea,
vomiting, diarrhea, malabsorption syndrome, small bowel resection).

- Patients with cardiac disease which in the Investigator's opinion may jeopardize the
safety of the patient or the compliance with the protocol.

- Patients with clinically significant bacterial, fungal, parasitic or viral infection
which require therapy. Patients with acute bacterial infections requiring antibiotic
use should delay screening/enrollment until the course of antibiotic therapy has been
completed.

- Patients with known active hepatitis A, B, C or who are HIV-positive.

- Patients with inadequate bone marrow reserve as demonstrated by:

1. Absolute neutrophil count (ANC) that is ≤ 1000/µL.

2. Platelet count that is < 100,000/µL without the assistance of growth factors,
thrombopoietic factors or platelet transfusions.

- Patients with any history of platelet counts < 50,000/µL or ANC < 500/µL except
during treatment for a myeloproliferative disorder or treatment with cytotoxic
therapy for any other reason.

- Patients with coagulation parameters (PT, PTT, INR) ≥ 1.5.

- Patients with known hypersensitivity to INC424 or other JAK1/2 inhibitors, or to
their excipients.

- Patients under ongoing treatment with another investigational medication or having
been treated with an investigational medication within 30 days of screening.

- Patients with any concurrent condition that, in the Investigator's opinion would
jeopardize the safety of the patient or compliance with the protocol.

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

50% or greater reduction in palpable spleen length and/or a 50% greater improvement in total symptom scores.

Outcome Time Frame:

48 Weeks

Safety Issue:

No

Principal Investigator

Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CINC424AGB02

NCT ID:

NCT01558739

Start Date:

May 2012

Completion Date:

November 2013

Related Keywords:

  • Primary Myelofibrosis (PMF)
  • Post Polycythaemia Myelofibrosis (PPV MF)
  • Post Essential Thrombocythaemia Myelofibrosis (PET-MF)
  • Ruxolitinib
  • INC424
  • myelofibrosis
  • PMF
  • post polycythemia myelofibrosis
  • PPV MF
  • post-essential thrombocythemia myelofibrosis
  • PET-MF
  • Primary Myelofibrosis
  • Polycythemia
  • Thrombocythemia
  • Essential Thrombocytosis
  • myeloproliferative Disorders
  • Bone Marrow Diseases
  • Haematologic Diseases
  • Blood Coagulation Disorders
  • Blood Platelet Disorders
  • Haemorrhagic Disorders
  • Primary Myelofibrosis
  • Polycythemia
  • Thrombocythemia, Essential
  • Thrombocytosis

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