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NCT Number: NCT01633372

An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis

This is a study of itacitinib (INCB039110) in patients with myelofibrosis. This study will evaluate safety and efficacy parameters of itacitinib (INCB039110).

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Key information

Conditions

MPN (Myeloproliferative Neoplasms) Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disorders Primary Myelofibrosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St Vincent's Hospital, Darlinghurst, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy.
  • Must score at least 1 point on the Dynamic International Prognostic Scoring System (DIPSS) for prognostic risk factors and have peripheral blast count <10% at both Screening and Baseline hematology assessments.
  • Subjects must discontinue all drugs used to treat underlying MF disease no later than Day -14.
  • Subjects must have hemoglobin value >/= 8.0g/dL and be willing to receive blood transfusions, have a platelet count >/=50x10^9/L and absolute neutrophil count (ANC) >/= 1x10^9/L.
  • Subjects must have palpable spleen or history of splenectomy
  • Active symptoms at the screening visit

Exclusion criteria

  • Women who are pregnant or breastfeeding, and men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively.
  • Subjects with impaired liver function, end stage renal disease on dialysis or clinically significant concurrent infections requiring therapy.
  • Subjects with unstable cardiac function or invasive malignancies over the previous 2 years except treated basal or squamous carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix and completely resected papillary thyroid and follicular thyroid cancers.

Treatment and study plan

Itacitinib

Drug

Other names: INCB039110

Primary outcomes

  1. Proportion of subjects with >/= 50% reduction in total symptom score in each dose group, as measured by the modified The Myelofibrosis Symptom Assessment Form (MFSAF) v3.0 diary

    Time frame: Baseline and Week 12

Secondary outcomes

  1. Proportion of subjects with >/= 35% reduction in spleen volume, and mean percent change in spleen volume

    Time frame: Baseline, Week 12 and Week 24

  2. Proportion of transfusion dependent subjects who exhibit changes in transfusion frequency over any 12 week period on study and proportion of transfusion independent subjects who exhibit changes in hemoglobin level

    Time frame: Baseline to Week 12; Week 13 to Week 24 through the end of study or study termination visit.

  3. Safety and tolerability of itacitinib as measured by adverse events.

    Time frame: Every 4-6 weeks through the end of study or early termination visit (approximately 33 weeks exclusive of the extension phase).

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

An Open-Label, Multiple Simon 2-Stage Study of Itacitinib Administered Orally to Subjects With Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF) or Post Essential Thrombocythemia Myelofibrosis (PET-MF)

Important dates

Study start
2012
Primary completion
2013
Study completion
2021
First posted
Jul 4, 2012
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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