Overview

This trial is active, not recruiting.

Conditions primary myelofibrosis, post polycythemia vera fibrosis, post essential thrombocythemia myelofibrosis
Treatment incb039110
Phase phase 2
Target JAK
Sponsor Incyte Corporation
Start date April 2012
End date December 2013
Trial size 125 participants
Trial identifier NCT01633372, INCB 39110-230

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
INCB039110 100 mg twice a day
incb039110
(Experimental)
INCB039110 200 mg twice a day
incb039110
(Experimental)
INCB039110 300 mg once a day
incb039110
(Experimental)
INCB039110 400 mg once a day
incb039110
(Experimental)
INCB039110 600 mg once a day
incb039110

Primary Outcomes

Measure
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

Measure
Proportion of subjects with >/= 35% reduction in spleen volume, and mean percent change in spleen volume
time frame: Baseline, Week 12 and Week 24
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.
Safety and tolerability of INCB039110 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).

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title An Open-Label, Multiple Simon 2-Stage Study of INCB039110 Administered Orally to Subjects With Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF) or Post Essential Thrombocythemia Myelofibrosis (PET-MF)
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Incyte Corporation.