Phase 1 Trial of ST-001 nanoFenretinide

Brief Summary: Fenretinide has been shown to be a relatively safe and effective anticancer therapy; however, dose limiting toxicities due to the excipients used in previous formulations has impeded its therapeutic utility. The product formulation in the current study (ST-001) is a phospholipid suspension of nanoparticle sized fenretinide. The current study is a Phase 1 trial in relapsed/refractory (R/R) T-cell non-Hodgkin's lymphoma in order to determine the safety profile, pharmacology, and maximum tolerated dose (MTD) of ST-001 nanoFenretinide. Targeted T-cell non-Hodgkin's lymphoma (T-Cell NHL) indications include: (1) Cutaneous T-cell lymphoma (CTCL) including mycosis fungoides (MF) and Sézary Syndrome (SS); (2) non-cutaneous T-cell lymphoma (non-CTCL) subtypes: angioimmunoblastic T-cell lymphoma (AITL), peripheral T-cell lymphoma (PTCL) not otherwise specified (NOS); and, follicular T-cell lymphoma (FTCL) as defined in the 2016 revision of the WHO classification of lymphoid malignancies.

For participation and/or eligibility criteria, visit Clinicaltrials.gov website provided below.

Website: https://clinicaltrials.gov/study/NCT04234048

Sponsor: SciTech Development, LLC

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. 

Please refer to this study by its ClinicalTrials.gov identifier: NCT04234048

Study Contact

Name: Louis M Scarmoutzos, PhD

Phone Number: (617) 283-2182

Email: lou@scitechdevelopment.com

Recruiting

Participating Locations:

University of Colorado Anschutz Medical Campus
Aurora, CO, United States
Principal Investigator
Brad Haverkos, MD
Contact
Rebecca Reed, MPH-PHP
rebecca.reed@cuanschutz.edu
303-724-4874
Recruiting
Ann Arbor, MI, United States
Principal Investigator
Ryan A. Wilcox, MD, PhD
Contact
Tina Jones
Recruiting
UT MD Anderson Cancer Center
Houston, TX, United States
Principal Investigator
Auris O Huen, MD, PharmD
Contact
Toni Vasquez
Recruiting
Detroit, MI, United States
Principal Investigator
Dipenkumar Modi, MD
Contact
Erik Carr
Recruiting
Columbia University Irving Medical Center
New York, NY, United States
Principal Investigator
Barbara Pro
Contact
Anxhela Kalia
Recruiting
University of Pittsburgh Medical Center
Pittsburgh, PA, United States
Principal Investigator
Oleg Akilov, MD, PhD
Contact
Jasmine Hicks
Recruiting
University of Southern California
Los Angeles, CA, United States
Principal Investigator
Ann Mohrbacher, MD
Contact
Christine Duran
Recruiting