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A Phase 2, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy (The ROCKstar Study)

Status
Closed
Cancer Type
Bone and Soft Tissue (including Sarcoma)
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03640481
Protocol IDs
KD025-213 (primary)
NCI-2018-02858
Study Sponsor
Kadmon Corporation, LLC

Summary

This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of KD025 in subjects with Chronic Graft Versus Host Disease (cGVHD) after at least 2 prior lines of systemic therapy

Objectives

Phase 2, open label, randomized, multicenter study in subjects with cGVHD who have previously been treated with at least 2 prior lines of systemic therapy. Approximately 126 subjects with active cGVHD will be randomized (1:1) to receive treatment with one of two KD025 regimens: - Arm A: KD025 200mg QD - Arm B: KD025 200mg BID Randomization will be stratified according to prior cGVHD treatment with ibrutinib (Yes / No) and severe cGVHD at baseline (Yes / No). Subjects may receive treatment in 28-day treatment cycles until progression of cGVHD. Subjects who have not achieved a response after 12 cycles of KD025 should be withdrawn if in the Investigator's judgment there is no evidence of clinical benefit. Subjects will undergo evaluations as outlined in the Study Assessments table. The primary endpoint is the overall response rate (ORR) with responses as defined by the 2014 National Institute of Health (NIH) Consensus Development Project on clinical trials in cGVHD.

Treatment Sites in Georgia

Georgia Cancer Center at Augusta University


1411 Laney Walker Boulevard
Augusta, GA 30912
www.augusta.edu/cancer/

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