A Phase 1b, open-label, randomized, dose-finding multicenter study to evaluate thesafety, pharmacokinetics andefficacy of GDC-8264 in combination with standard of care in the treatment of acutegraft-versus-host disease in patients who have undergone allogeneic hematopoieticstem cell transplantation
Study of GDC-8264 in Stem Cell Transplant Patients with Acute Graft-Versus-Host-Disease (acute GVHD)
Sponsor: Genentech, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAU3835
U.S. Govt. ID: NCT05673876
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: This study is testing a drug called GDC-8264, which is being developed to treat acute graft-versus-host-disease (acute GVHD). GDC-8264 is an experimental drug, which means health authorities have not approved GDC-8264 in combination with standard medications for the treatment of acute GVHD. The purpose of this study is to evaluate the effects, good or bad, of GDC-8264 plus standard medications on patients who have been diagnosed with acute GVHD and have increased risk of poor clinical response to standard treatment. GDC-8264 will be given to you as pills every day throughout the study treatment period in addition to the standard medications, prednisone or methylprednisolone. You will receive GDC-8264 to treat acute GVHD after HSCT (hematopoietic stem cell transplantation). The goal is for GDC-8264 to reduce the amount of tissue damage caused by acute GVHD and improve outcomes for patients with more severe or high-risk disease.
This study is closed
Ran Reshef, MD
Do You Qualify?
Are you at least 18 years old? Yes No
Do you have Acute Graft-Versus-Host-Disease (acute GVHD)? Yes No
Have you had stem cell transplant? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Research Nurse Navigator