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
|Condition or disease||Intervention/treatment||Phase|
|Acute Graft-versus-host Disease||Drug: Itacitinib Drug: Corticosteroid||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||March 20, 2018|
|Actual Primary Completion Date :||November 30, 2019|
|Actual Study Completion Date :||February 17, 2020|
Experimental: Itacitinib + corticosteroids
Itacitinib administered in combination with corticosteroids.
Itacitinib administered orally once daily at the protocol-defined dose.
Other Name: INCB039110
Either oral prednisolone or intravenous methylprednisolone at the investigator's discretion.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497273
|Study Director:||Rodica Morariu-Zamfir, MD||Incyte Corporation|