Clinical Trial: Study of INCB039110 in Combination With Corticosteroids for the Treatment of Acute GVHD
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Randomized, Parallel-Cohort Phase 1 Study of INCB039110 in Combination With Corticosteroids for the Treatment of Acute Graft Versus Host Disease
Brief Summary: To determine if INCB039110 in combination with corticosteroids is safe and tolerable in patients with Grade IIB-IVD acute graft-versus-host disease (GVHD).
Detailed Summary:
Sponsor: Incyte Corporation
Current Primary Outcome: Assess safety and tolerability of study treatment as measured by the frequency and severity of adverse events and serious adverse events [ Time Frame: First dose of study drug to 30 days after the last dose of study drug ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Overall Response Rate (ORR) [ Time Frame: Days 14, 28, 56 and 100 ]
- Maximum Observed Plasma Concentration (Cmax) of the two treatment groups INCB039110 [ Time Frame: Day 1 and Day 7 ]
- Time to Reach the Maximum Plasma Concentration (Tmax) of the two treatment groups INCB039110 [ Time Frame: Day 1 and Day 7 ]
- Area Under the Plasma Concentration-time Curve (AUC) of the two treatment groups INCB039110 [ Time Frame: Day 1 and Day 7 ]
- Minimum observed plasma concentration (Cmin) of the two treatment groups INCB039110 [ Time Frame: Day 1 and Day 7 ]
Original Secondary Outcome: Same as current
Information By: Incyte Corporation
Dates:
Date Received: November 20, 2015
Date Started: December 2015
Date Completion: July 2017
Last Updated: January 4, 2017
Last Verified: January 2017
