A Phase 1a/1b Trial in Relapsed/Refractory Small Cell Lung Cancer to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a Fenretinide Phospholipid Suspension (12.5 mg/mL) for Intravenous Infusion
SciTech Development, Inc.
Summary
This study evaluates a fenretinide phospholipid suspension for the treatment of small cell lung cancer (SCLC).
Description
Fenretinide has been shown to be a relatively safe and effective anticancer therapy; however, low fenretinide bioavailability and dose limiting toxicities due to 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 in relapsed/refractory small cell lung cancer to determine the safety profile, pharmacology, and maximum tolerated dose (MTD) of ST-001.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Small cell lung cancer (SCLC). * Patients must all have at least one measurable disease site using RECIST version 1.1 criteria. * Patients must have had prior treatment with radiation therapy or with platinum-based chemotherapy ± immunotherapy with no limit on the number of prior systemic treatment regimens. * Relapsed/refractory disease of any stage if incurable in nature, is eligible for enrollment. * Minimum of 4 weeks must have elapsed since last systemic treatment or radiation therapy treatment (or 6 weeks for any nitrosourea-containing regimens), and patients must…
Interventions
- DrugFenretinide
Intravenous administration
- DrugFenretinide
Intravenous administration
Location
- University of Southern CaliforniaLos Angles, California