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
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 |
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
Investigator
Ran Reshef, MD
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 |