Actively Recruiting
ST-001 nanoFenretinide in Relapsed/ Refractory Small Cell Lung Cancer
Led by SciTech Development, Inc. · Updated on 2025-12-15
44
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study evaluates a fenretinide phospholipid suspension for the treatment of small cell lung cancer (SCLC).
CONDITIONS
Official Title
ST-001 nanoFenretinide in Relapsed/ Refractory Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of small cell lung cancer (SCLC).
- At least one measurable disease site per RECIST 1.1 criteria.
- Prior treatment with radiation or platinum-based chemotherapy with or without immunotherapy.
- Relapsed or refractory disease of any stage if incurable.
- At least 4 weeks since last systemic or radiation treatment (6 weeks if nitrosourea-based).
- ECOG performance status of 0 or 1 (Karnofsky 60% or higher).
- Life expectancy over 6 months.
- Normal organ and marrow function.
- Fasting triglyceride level under 300 mg/dL at enrollment.
- Women must be non-childbearing (menopausal or surgically sterile for over 1 year).
- Informed consent obtained from patient or legally authorized representative.
You will not qualify if you...
- Mixed small cell and non-small cell lung cancer tumors.
- Pregnant or breastfeeding women.
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) before study entry or unresolved adverse events from prior treatments.
- Receiving other investigational agents.
- History of central nervous system metastases unless asymptomatic and controlled without progression for at least 4 weeks.
- Allergic reactions or sensitivity to retinoids or ST-001 ingredients.
- Concurrent treatment with strong CYP3A inducers or moderate to strong CYP3A inhibitors.
- Uncontrolled illnesses such as active infections, symptomatic heart failure, unstable angina, cardiac arrhythmias, prolonged QTc interval, or psychiatric/social conditions limiting compliance.
- HIV-positive patients on combination antiretroviral therapy.
- Active hepatitis infections.
- Presence of night blindness, day blindness, or other retinal or eye conditions including glaucoma.
- History of other solid tumors diagnosed within last 3 years, except certain treated skin or in situ cancers without active disease for 2 years.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Southern California
Los Angles, California, United States, 90007
Actively Recruiting
Research Team
L
Louis M Scarmoutzos, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here