Clinical Trial: A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 2a, Dose-Escalation, Open-Label Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease

Brief Summary: This study is being conducted to evaluate the safety, tolerability, and activity of KD025 in adult subjects with chronic Graft versus Host Disease (cGVHD).

Detailed Summary: A total of 48 subjects will be enrolled to receive orally administered KD025 200 mg QD (once daily), KD025 200 mg BID (twice daily), or KD025 400 mg QD. Study drug will be administered in 28-day cycles for 6 cycles (24 weeks). Subjects may receive study drug in the inpatient or outpatient setting.
Sponsor: Kadmon Corporation, LLC

Current Primary Outcome:

• Overall response criteria (PR + CR) [ Time Frame: 24 weeks ]
  To evaluate overall response from baseline to 24 weeks after dosing with KD025 200 mg QD, KD025 200 mg BID, or KD025 400 mg QD in subjects with cGVHD. The overall response will be evaluated through the NIH Consensus Development Project on Clinical Trials in cGVHD.
• Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24 weeks ]
  To evaluate the safety and tolerability of KD025 200 mg QD, KD025 200 mg BID, or KD025 400 mg QD when administered for 24 weeks to subjects with cGVHD

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Kadmon Corporation, LLC

Dates:
Date Received: July 20, 2016
Date Started: August 2016
Date Completion:
Last Updated: February 7, 2017
Last Verified: February 2017