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Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects

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ClinicalTrials.gov Identifier: NCT03497273
Recruitment Status : Completed
First Posted : April 13, 2018
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE April 6, 2018
First Posted Date  ICMJE April 13, 2018
Last Update Posted Date March 3, 2020
Actual Study Start Date  ICMJE March 20, 2018
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2018)
Number of treatment-emergent adverse events [ Time Frame: Up to approximately 12 months ]
Defined as any adverse event reported for the first time or worsening of a pre-existing event after first dose of study drug.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2018)
  • Cmax of INCB039110 [ Time Frame: Up to approximately 1 month ]
    Maximum observed plasma concentration.
  • Cl/F of INCB039110 [ Time Frame: Up to approximately 1 month ]
    Apparent oral dose clearance.
  • Objective response rate [ Time Frame: Up to 100 days ]
    Defined as the proportion of participants demonstrating a complete response, very good partial response, or partial response.
  • Nonrelapse mortality [ Time Frame: Up to approximately 12 months ]
    Defined as the proportion of participants who died due to causes other than malignancy.
  • Duration of response [ Time Frame: Up to approximately 12 months ]
    Defined as the interval from first response until GVHD progression or death.
  • Time to response [ Time Frame: Up to approximately 12 months ]
    Defined as the interval from treatment initiation to first response.
  • Malignancy relapse rate [ Time Frame: Up to approximately 12 months ]
    Defined as the proportion of participants whose underlying malignancy relapses.
  • Failure-free survival [ Time Frame: Up to 6 months ]
    Defined as the proportion of participants who are still alive, have not relapsed, have not required additional therapy for aGVHD, and have not demonstrated signs or symptoms of chronic GVHD (cGVHD).
  • Overall survival [ Time Frame: Up to approximately 12 months ]
    Defined as the interval from study enrollment to death due to any cause.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects
Official Title  ICMJE An Open-Label Single-Arm Phase 1 Study Evaluating Safety of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects
Brief Summary The purpose of this study is to assess the safety and tolerability of itacitinib in combination with corticosteroids in Japanese subjects with Grades II to IV acute graft-versus-host disease (aGVHD).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Graft-versus-host Disease
Intervention  ICMJE
  • Drug: Itacitinib
    Itacitinib administered orally once daily at the protocol-defined dose.
    Other Name: INCB039110
  • Drug: Corticosteroid
    Either oral prednisolone or intravenous methylprednisolone at the investigator's discretion.
Study Arms  ICMJE Experimental: Itacitinib + corticosteroids
Itacitinib administered in combination with corticosteroids.
Interventions:
  • Drug: Itacitinib
  • Drug: Corticosteroid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2020)
14
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2018)
20
Actual Study Completion Date  ICMJE February 17, 2020
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Japanese; subject was born in Japan and has not lived outside of Japan for a total of > 10 years, and subject can trace maternal and paternal Japanese ancestry.
  • Has undergone 1 allo-hematopoietic stem cell transplant (HSCT) from any donor and source (unrelated, sibling, haploidentical donors with any matching) using bone marrow, peripheral blood or cord blood for hematologic malignancies. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible.
  • Clinically suspected Grades II to IV aGVHD as per Mount Sinai Acute GVHD International Consortium (MAGIC) criteria, occurring after allo-HSCT and any anti-GVHD prophylactic medication.
  • Evidence of myeloid engraftment (eg, absolute neutrophil count [ANC] ≥ 0.5 × 10^9/L for 3 consecutive assessments if ablative therapy was previously used). Use of growth factor supplementation is allowed.
  • Female subjects should agree to use medically acceptable contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test before the start of study drug administration if of childbearing potential or must have evidence of non-childbearing potential by fulfilling protocol-defined criteria at screening.

Exclusion Criteria:

  • Has received more than 1 allo-HSCT.
  • Has received more than 2 days of systemic corticosteroids for aGVHD.
  • Presence of GVHD overlap syndrome.
  • Presence of an active uncontrolled infection (defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection; persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection).
  • Known human immunodeficiency virus infection.
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation. For subjects with negative HBsAg and positive total hepatitis B core antibody and for subjects who are positive for HCV antibody, HBV DNA and HCV RNA must be undetectable upon testing.
  • Evidence of relapsed primary disease or having been treated for relapse after the allo-HSCT was performed.
  • Any corticosteroid therapy (for indication other than GVHD) at doses > 1 mg/kg per day methylprednisolone or equivalent within 7 days of enrollment.
  • Severe organ dysfunction unrelated to underlying GVHD, including the following:

    • Cholestatic disorders or unresolved veno-occlusive disease of the liver.
    • Clinically significant or uncontrolled cardiac disease.
    • Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen.
  • Serum creatinine > 2.0 mg/dL or creatinine clearance < 40 mL/min measured or calculated by Cockroft-Gault equation
  • Received Janus kinase (JAK) inhibitor therapy after allo-HSCT for any indication. Treatment with a JAK inhibitor before allo-HSCT is permitted.
  • Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03497273
Other Study ID Numbers  ICMJE INCB 39110-118
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Incyte Corporation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Incyte Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rodica Morariu-Zamfir, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP