A Phase 1a/1b Trial in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma to Determine theSafety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a fenretinide phospholipidsuspension (12.5 mg/mL) for Intravenous Infusion
Sponsor: |
SciTech Development, LLC |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAU7936 |
U.S. Govt. ID: |
NCT04234048 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
The purpose of this study is to see what effects, good and/or bad, the study drug, ST-001, has on you and your cancer, to find the best dose for treating your condition, and to see how safe ST-001 is for participants with your condition. This study will help us understand more about whether intravenous (injected into the vein) ST-001, will be a useful study treatment for subjects with Relapsed/Refractory T-cell Non-Hodgkin Lymphoma (T-Cell NHL). Relapsed or refractory disease means your disease that has come back after initial treatment or did not respond to initial treatment. Approximately 46 patients will be enrolled across 5-10 clinical sites nationwide. ST-001 has not been studied in human clinical trials yet.
Investigator
Barbara Pro, MD
Are you at least 18 years of age or older? |
Yes |
No |
Do you have relapsed or refractory disease after at least two prior systemic drug treatment regimens? |
Yes |
No |
Are you willing to come into the clinic for additional evaluations and treatment? |
Yes |
No |