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

Incyte

Status and phase: Completed; Phase 2

Conditions: MPN (Myeloproliferative Neoplasms)

Treatments: Drug: itacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01633372

INCB 39110-230

Details and patient eligibility

About

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

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 5 patient groups

itacitinib 100 mg

Experimental group

Description:

itacitinib 100 mg twice a day

Treatment:

Drug: itacitinib

itacitinib 200 mg

Experimental group

Description:

itacitinib 200 mg twice a day

Treatment:

Drug: itacitinib

itacitinib 300 mg

Experimental group

Description:

itacitinib 300 mg once a day

Treatment:

Drug: itacitinib

itacitinib 400 mg

Experimental group

Description:

itacitinib 400 mg once a day

Treatment:

Drug: itacitinib

itacitinib 600 mg

Experimental group

Description:

itacitinib 600 mg once a day

Treatment:

Drug: itacitinib