Clinical Trial: GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graf
Brief Summary: The purpose of this study is to evaluate itacitinib or placebo in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).
Detailed Summary:
Sponsor: Incyte Corporation
Current Primary Outcome: Overall response rate based on Center for International Blood and Marrow Transplant Research (CIBMTR) response index [ Time Frame: Day 28 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Nonrelapse mortality [ Time Frame: Month 6 ]Defined as the percentage of participants who died due to causes other than malignancy relapse.
- Duration of response [ Time Frame: Baseline through 30-35 days after end of treatment, expected to average approximately 6 months ]Defined as the interval from first response until GVHD progression or death.
- Cmax of itacitinib when administered in combination with corticosteroids [ Time Frame: Protocol-defined timepoints up to Day 28 ]Defined as maximum observed plasma concentration.
- Cmin of itacitinib when administered in combination with corticosteroids [ Time Frame: Protocol-defined timepoints up to Day 28 ]Defined as minimum observed plasma concentration.
- Tmax of itacitinib when administered in combination with corticosteroids [ Time Frame: Protocol-defined timepoints up to Day 28 ]Defined as time to maximum plasma concentration.
- AUC of itacitinib when administered in combination with corticosteroids [ Time Frame: Protocol-defined timepoints up to Day 28 ]Defined as area under the concentration-time curve.
- CL/F of itacitinib when administered in combination with corticosteroids [ Time Frame: Protocol-defined timepoints up to Day 28 ]Defined as oral dose clearance.
Original Secondary Outcome: Same as current
Information By: Incyte Corporation
Dates:
Date Received: May 2, 2017
Date Started: June 2017
Date Completion: March 2020
Last Updated: May 2, 2017
Last Verified: May 2017