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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03497273
Other study ID # INCB 39110-118
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 20, 2018
Est. completion date February 17, 2020

Study information

Verified date March 2020
Source Incyte Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date February 17, 2020
Est. primary completion date November 30, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Itacitinib
Itacitinib administered orally once daily at the protocol-defined dose.
Corticosteroid
Either oral prednisolone or intravenous methylprednisolone at the investigator's discretion.

Locations

Country Name City State
Japan JA-Aichi Anjo Kosei Hospital Anjo-Shi Aichi
Japan St. Luke's International Hospital Chuo Ku Tokyo-To
Japan Tokai University Hospital Isehara-Shi Kanagawa
Japan Jiaikai Imamura General Hospital Kagoshima-Shi Kagoshima
Japan NHO Kumamoto Medical Center Kumamoto-shi Kumamoto-Ken
Japan Jikei University Hospital Minato-ku Tokyo-To
Japan Shizuoka Cancer Center Nagaizumi-cho Shizuoka-Ken
Japan Nagoya University Hospital Nagoya-Shi Aichi
Japan Hyogo College of Medicine Hospital Nishinomiya-Shi Hyogo
Japan Okayama University Hospital Okayama-shi Okayama-Ken
Japan Osaka City University Hospital Osaka-Shi Osaka
Japan Hokkaido University Hospital Sapporo-shi Hokkaido
Japan Hokuyukai Sapporo Hokuyu Hospital Sapporo-Shi Hokkaido
Japan Tohoku University Hospital Sendai-shi Miyagi-Ken
Japan Jichi Medical University Hospital Shimotsuke-shi Tochigi-Ken
Japan University of Tsukuba Hospital Tsukuba-shi Ibaraki-Ken
Japan Kanagawa Cancer Center Yokohama-shi Kanagawa-Ken

Sponsors (1)

Lead Sponsor Collaborator
Incyte Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of treatment-emergent adverse events Defined as any adverse event reported for the first time or worsening of a pre-existing event after first dose of study drug. Up to approximately 12 months
Secondary Cmax of INCB039110 Maximum observed plasma concentration. Up to approximately 1 month
Secondary Cl/F of INCB039110 Apparent oral dose clearance. Up to approximately 1 month
Secondary Objective response rate Defined as the proportion of participants demonstrating a complete response, very good partial response, or partial response. Up to 100 days
Secondary Nonrelapse mortality Defined as the proportion of participants who died due to causes other than malignancy. Up to approximately 12 months
Secondary Duration of response Defined as the interval from first response until GVHD progression or death. Up to approximately 12 months
Secondary Time to response Defined as the interval from treatment initiation to first response. Up to approximately 12 months
Secondary Malignancy relapse rate Defined as the proportion of participants whose underlying malignancy relapses. Up to approximately 12 months
Secondary Failure-free survival 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). Up to 6 months
Secondary Overall survival Defined as the interval from study enrollment to death due to any cause. Up to approximately 12 months
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