Moffitt logo

Clinical Trials Search

Clinical Trial 19800

Cancer Type: Malignant Hematology
Interventions:KD025 ()

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Aleksandr Lazaryan

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

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)

Summary

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

Objective

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)

Inclusion Criteria

  • Male and female subjects at least 16 years of age who have had allogenic hematopoietic cell transplant (HCT).
  • Previously received at least 2 and not more than 5 lines of systemic therapy for cGVHD
  • Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening
  • Have persistent cGVHD manifestations and systemic therapy is indicated
  • Karnofsky Performance Score of ≥ 60
  • Weight >/- 40 kg

  • Exclusion Criteria

  • Received a stable dose/regimen of systemic cGVHD treatments for at least 2 weeks prior to screening. Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, metholtrexate, rituximab, and extracorporeal photophoresis (ECP) are acceptable. Systemic investigational GVHD treatments are not permitted.
  • Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
  • Current treatment with ibrutinib. Prior treatment with ibrutinib is allowed with a washout of at least 28 days prior to randomization.
  • Pregnancy or breastfeeding
  • History of other severe illness that would make the subject, in the opinion of the physician, unsuitable for the study.
  • Known active hepatitis B (HBV) or hepatitis C (HCV) or history of human immunodeficiency virus (HIV).
  • Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of enrollment, with the exception of: (1) Completely resected basal cell or squamous cell carcinoma of the skin. (2) Carcinoma in situ of the cervix (3) Resected breast ductal carcinoma in situ (4) Prostate cancer with Gleason score > Has had previous exposure to KD025
  • Known allergy/sensitivity to KD025 or any other ROCK2 inhibitor
  • Treatment with any non-GVHD investigational agent, or any investigational device or procedure, within 28 days (or 5 half-lives, whichever is greater) of enrollment.
  • Other exclusions apply