An Open-Label Phase 2 Study of Itacitinib (INCB039110) in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Subjects With Myelofibrosis

  • STATUS
    Recruiting
Updated on 25 August 2021
myelofibrosis
leukemia
myeloproliferative disorders

Summary

The purpose of this study is to evaluate the efficacy and safety of itacitinib combined with low-dose ruxolitinib or itacitinib alone in subjects with myelofibrosis.

 

This is an open-label Phase 2 study with 2 cohorts:

Cohort A: Itacitinib plus ruxolitinib 

  • Drug: Itacitinib self-administered orally once daily at the   protocol-defined dose.
  • Drug: Ruxolitinib self-administered orally at the stable dose of <20 mg daily established before entering the study.

Cohort B: Itacitinib alone

  • Drug: Itacitinib self-administered orally once daily at the   protocol-defined dose.

 

Description

For more information, please contact Incyte Corporation at 1.855.463.3463 or visit www.incyteclinicaltrials.com

Details
Condition leukemia, Leukemia (Pediatric)
Clinical Study IdentifierTX218056
Last Modified on25 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Cohort A only
Receiving ruxolitinib dose of less than 20 mg daily with no dose increase or no dose modification in the last 8 weeks before screening visit
Cohort B only
Must have had initial reduction in spleen on ruxolitinib treatment
Followed by documented evidence of progression in spleen length or volume OR
Discontinued ruxolitinib for hematologic toxicities, after the initial reduction in spleen length or volume
All subjects
Confirmed diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis according to revised World Health Organization 2016 criteria
Must have palpable spleen of ≥ 5 cm below the left subcostal margin on physical examination at the screening visit
Eastern Cooperative Oncology Group performance status of 0, 1, or 2
Screening bone marrow biopsy specimen available or willingness to undergo a bone marrow biopsy at screening/baseline; willingness to undergo bone marrow biopsy at Week 24
Life expectancy of at least 24 weeks
Willingness to avoid pregnancy or fathering children

Exclusion Criteria

Lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade 1 or better
Previous treatment with itacitinib or JAK1 inhibitors (JAK1/JAK2 inhibitor ruxolitinib is permitted)
Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications
Recent history of inadequate bone marrow reserve as demonstrated by protocol-defined criteria
Inadequate liver function at screening and baseline visits as demonstrated by protocol-defined criteria
Inadequate renal function at screening and baseline visits as demonstrated by protocol-defined criteria
Active bacterial, fungal, parasitic, or viral infection that requires therapy
Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation: HBV DNA and HCV RNA must be undetectable. Subjects cannot be positive for hepatitis B surface antigen or anti-hepatitis B core antibodies. Subjects who have positive anti-HBs as the only evidence of prior exposure may participate in the study provided that there is both 1) no known history of HBV infection and 2) verified receipt of hepatitis B vaccine
Known human immunodeficiency virus infection
Clinically significant or uncontrolled cardiac disease
Active invasive malignancy 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. Subjects with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery may be enrolled as long as they have a reasonable expectation to have been cured with the treatment modality received
Splenic irradiation within 6 months before receiving the first dose of itacitinib
Use of any prohibited concomitant medications
Active alcohol or drug addiction that would interfere with their ability to comply with the study requirements
Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of itacitinib or anticipated during the study
Use of concomitant treatment of fluconazole at a dose > 200 mg (for ruxolitinib subjects treated in Cohort A only)
Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy
Currently breastfeeding or pregnant
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