Exploratory Phase II Study of INC424 Patients With Primary Myelofibrosis (PMF) or Post Polycythaemia Myelofibrosis (PPV MF) or Post Essential Thrombocythaemia Myelofibrosis (PET-MF)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-01-31

Brief Summary

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The primary objective of this study is to evaluate the efficacy of INC424 in patients with PMF, PPV MF, or PET-MF using a composite measure of either an objective endpoint (\> 50% reduction in splenomegaly using palpitation at 48 weeks) and/or a subjective endpoint (\>50% reduction in total symptom score at 48 weeks).

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Detailed Description

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Conditions

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Primary Myelofibrosis (PMF) Post Polycythaemia Myelofibrosis (PPV MF) Post Essential Thrombocythaemia Myelofibrosis (PET-MF)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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INC424

Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.

Group Type EXPERIMENTAL

INC424

Intervention Type DRUG

Ruxolitinib was provided in 5 mg tablets, packaged in bottles. 15 - 20 mg (dose based on Baseline platelet count) twice daily.

Interventions

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INC424

Ruxolitinib was provided in 5 mg tablets, packaged in bottles. 15 - 20 mg (dose based on Baseline platelet count) twice daily.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No