Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

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.

Official Title

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

Keywords

MPN (Myeloproliferative Neoplasms)MyelofibrosisJanus kinase (JAK) inhibitoritacitinibruxolitinibPrimary MyelofibrosisMyeloproliferative Disorders

Eligibility

You can join if…

Open to people ages 18 years and up

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
  • .
  • Life expectancy of at least 24 weeks.
  • Willingness to avoid pregnancy or fathering children

You CAN'T join if...

  • 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.

Locations

  • UC Irvine Medical Centeraccepting new patients
    OrangeCalifornia92868United States
  • Arizona Oncology Associatesaccepting new patients
    TempeArizona85284United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
ID
NCT03144687
Phase
Phase 2
Study Type
Interventional
Last Updated