[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06922539":3,"trial-entities:NCT06922539":147,"trial-summary:NCT06922539":151},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":47,"secondary_outcomes":52,"sex":77,"minimum_age":78,"maximum_age":79,"healthy_volunteers":15,"eligibility_criteria":80,"std_ages":103,"locations":106,"central_contacts":136,"overall_officials":141,"references":145,"see_also_links":146},"NCT06922539","ST-001-020","Phase 1 Trial of ST-001 nanoFenretinide in Relapsed\u002F Refractory Small Cell Lung Cancer","A Phase 1b Trial in Relapsed\u002FRefractory Small Cell Lung Cancer to Determine the Clinical Activity, Safety Profile, and Pharmacology of ST-001, a Fenretinide Phospholipid Suspension (12.5 mg\u002FmL) for Intravenous Infusion","RECRUITING","2028-10-01","2026-08","2026-08-19","2025-12-11","SciTech Development, Inc.","INDUSTRY",false,"This study evaluates a fenretinide phospholipid suspension for the treatment of small cell lung cancer (SCLC).","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\u002Frefractory small cell lung cancer to determine the clinical activity, safety profile, and pharmacology of ST-001.",[19],"Small Cell Lung Cancer",[21,22,23,24,25,26,27],"fenretinide","SCLC","Relapsed\u002FRefractory","Relapsed\u002FRefractory SCLC","R\u002FR SCLC","ST-001","intravenous administration","INTERVENTIONAL","TREATMENT",[31],"PHASE1",{"count":33,"type":34},44,"ESTIMATED",[36,43],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":42},"DRUG","Fenretinide","Intravenous administration",[41],"Standard Phase 1a",[26],{"type":37,"name":38,"description":39,"armGroupLabels":44,"otherNames":46},[45],"Expanded Phase 1b",[26],[48],{"measure":49,"description":50,"timeFrame":51},"To evaluate the progression-free survival (PFS) of patients with relapsed or refractory small-cell lung cancer (SCLC) who are treated with ST-001 after receiving at least one prior systemic therapy.","Evaluate progression-free survival (PFS) in patients with relapsed or refractory small-cell lung cancer (SCLC) after prior platinum-based chemotherapy ± immunotherapy who are treated with ST-001 (12.5mg\u002FmL) for IV Infusion, using a Simon 2-stage study design with an interim analysis for futility. PFS is defined as the time from start of treatment to disease progression (increase in tumor size, new metastases) or death.","From enrollment to end of treatment is 3 weeks",[53,56,59,62,65,68,71,74],{"measure":54,"description":55,"timeFrame":51},"To describe the toxicity profile of ST-001 in patients with SCLC","Determine the number of participants with treatment-related adverse events as assessed by CTCAE v5.0",{"measure":57,"description":58,"timeFrame":51},"To observe and record anti-tumor activity of ST-001 in patients with SCLC","Preclinical studies with fenretinide suggest potential efficacy against SCLC. Patients will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. Objective Response Rate (ORR) and progression-free survival (PFS) will be used as tumor response endpoints in this study.",{"measure":60,"description":61,"timeFrame":51},"Objective Response Rate (ORR)","ORR = (Number of patients with complete or partial response) \u002F (Total number of evaluable patients) x 100. Minimum duration of individual patient participation is 3 weeks (one cycle of therapy) to be evaluable for response.",{"measure":63,"description":64,"timeFrame":51},"To describe the pharmacokinetics of fenretinide when ST-001 is administered by daily infusion for 5 consecutive days every 3 weeks.","The endpoint for the pharmacokinetic studies is to assess fenretinide blood plasma levels as a function of administered dose and to determine the following PK parameters: maximum fenretinide concentration (Cmax), time of Cmax (Tmax), volume of distribution (Vd), clearance (CL), elimination and fenretinide half-life (t½).",{"measure":66,"description":67,"timeFrame":51},"Cmax","Peak plasma fenretinide concentration (in ng\u002FmL)",{"measure":69,"description":70,"timeFrame":51},"Tmax","The time it takes for fenretinide to reach the maximum concentration (Cmax) after drug administration (in hours)",{"measure":72,"description":73,"timeFrame":51},"Vd","Volume of distribution; fenretinide's propensity to either remain in the plasma or redistribute to other tissue compartments (in liters)",{"measure":75,"description":76,"timeFrame":51},"t½","Fenretinide elimination and half-life; the time it takes for the amount of a drug's active substance in your body to reduce by half (hours)","ALL","18 Years",null,{"inclusion":81,"exclusion":93,"raw_text":102},[82,83,84,85,86,87,88,89,90,91,92],"Small cell lung cancer (SCLC).","Patients must all have at least one measurable disease site using RECIST version 1.1 criteria.","Patients must have relapsed or refractory disease to prior treatment with platinum-based chemotherapy ± immunotherapy. There is no limit on the number of prior systemic treatment regimens.","Relapsed\u002Frefractory disease of any stage if incurable in nature, is eligible for enrollment.","Minimum of 3 weeks or 5 half-lives, whichever is shorter must have elapsed since last systemic treatment. A 1-week washout is required for palliative radiation treatment and 2-week washout is required for whole brain radiation treatment. Patients must have recovered from all clinically significant toxicity of last treatment and cleared the pharmacological agent(s) used previously.","ECOG performance status 0-1 (Karnofsky ≥60%).","Life expectancy greater than 6 months.","Patients must have normal organ and marrow function.","Triglyceride blood level (fasting) \\\u003C300mg\u002FdL at time of enrollment (normal: \\\u003C150mg\u002FdL; borderline high = 150-199mg\u002FdL; high = 200-499mg\u002FdL; very high = 500mg\u002FdL or higher).","Women of non-child bearing potential, that is women who have been menopausal or surgically sterile for more than 1 year, are eligible for enrolment in the study.","Informed consent of the patient or a legal authorized representative (LAR) must be obtained prior to any study related procedures.",[94,95,96,97,98,99,100,101],"Mixed SCLC\u002FNSCLC tumors are not eligible. Pregnant or breastfeeding women cannot take part in this study. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.","Patients who are receiving any other investigational agents. SCLC patients with history of CNS metastasis may be included if CNS disease is asymptomatic and controlled without progression at least 4 weeks after treatment with radiotherapy, and patient is either no longer taking corticosteroids or on a stable dose of corticosteroids.","History of allergic reactions or sensitivity to retinoids or to any excipients of ST-001.","Patients who require concurrent treatment with drugs that are strong CYP3A inducers are excluded from the trial.","Patients who require concurrent treatment with drugs that are strong to moderate CYP3A inhibitors are excluded from the trial.","Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NY heart classification III\u002FIV), unstable angina pectoris, cardiac arrhythmia, QTc interval \\>450 milliseconds for men and \\>460 milliseconds for women on baseline triplicate ECG, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","HIV-positive patients on combination antiretroviral therapy are ineligible. Patients with any active hepatitis infections. Presence of nyctalopia (night blindness), or hemeralopia (defective vision in a bright light, 'day blindness') at enrollment, or any other retinal, ophthalmological condition (e.g.: retinitis pigmentosa, choroidoretinitis and xerophthalmia), and glaucoma.","History of solid tumor malignancy other than the diseases under study, diagnosed within the last three (3) years of study enrollment, excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer, in situ breast cancer, in situ prostate cancer (patients must have shown no evidence of active disease for 2 years prior to enrollment).","Inclusion Criteria:\n\n* Small cell lung cancer (SCLC).\n* Patients must all have at least one measurable disease site using RECIST version 1.1 criteria.\n* Patients must have relapsed or refractory disease to prior treatment with platinum-based chemotherapy ± immunotherapy. There is no limit on the number of prior systemic treatment regimens.\n* Relapsed\u002Frefractory disease of any stage if incurable in nature, is eligible for enrollment.\n* Minimum of 3 weeks or 5 half-lives, whichever is shorter must have elapsed since last systemic treatment. A 1-week washout is required for palliative radiation treatment and 2-week washout is required for whole brain radiation treatment. Patients must have recovered from all clinically significant toxicity of last treatment and cleared the pharmacological agent(s) used previously.\n* ECOG performance status 0-1 (Karnofsky ≥60%).\n* Life expectancy greater than 6 months.\n* Patients must have normal organ and marrow function.\n* Triglyceride blood level (fasting) \\\u003C300mg\u002FdL at time of enrollment (normal: \\\u003C150mg\u002FdL; borderline high = 150-199mg\u002FdL; high = 200-499mg\u002FdL; very high = 500mg\u002FdL or higher).\n* Women of non-child bearing potential, that is women who have been menopausal or surgically sterile for more than 1 year, are eligible for enrolment in the study.\n* Informed consent of the patient or a legal authorized representative (LAR) must be obtained prior to any study related procedures.\n\nExclusion Criteria:\n\n* Mixed SCLC\u002FNSCLC tumors are not eligible. Pregnant or breastfeeding women cannot take part in this study. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n* Patients who are receiving any other investigational agents. SCLC patients with history of CNS metastasis may be included if CNS disease is asymptomatic and controlled without progression at least 4 weeks after treatment with radiotherapy, and patient is either no longer taking corticosteroids or on a stable dose of corticosteroids.\n* History of allergic reactions or sensitivity to retinoids or to any excipients of ST-001.\n* Patients who require concurrent treatment with drugs that are strong CYP3A inducers are excluded from the trial.\n* Patients who require concurrent treatment with drugs that are strong to moderate CYP3A inhibitors are excluded from the trial.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NY heart classification III\u002FIV), unstable angina pectoris, cardiac arrhythmia, QTc interval \\>450 milliseconds for men and \\>460 milliseconds for women on baseline triplicate ECG, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* HIV-positive patients on combination antiretroviral therapy are ineligible. Patients with any active hepatitis infections. Presence of nyctalopia (night blindness), or hemeralopia (defective vision in a bright light, 'day blindness') at enrollment, or any other retinal, ophthalmological condition (e.g.: retinitis pigmentosa, choroidoretinitis and xerophthalmia), and glaucoma.\n* History of solid tumor malignancy other than the diseases under study, diagnosed within the last three (3) years of study enrollment, excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer, in situ breast cancer, in situ prostate cancer (patients must have shown no evidence of active disease for 2 years prior to enrollment).",[104,105],"ADULT","OLDER_ADULT",[107,123],{"facility":108,"status":8,"city":109,"state":110,"zip":111,"country":112,"contacts":113,"geoPoint":120},"University of Southern California","Los Angeles","California","90007","United States",[114,117],{"name":115,"role":116},"Angelina Lee","CONTACT",{"name":118,"role":119},"Jacob S Thomas, M.D.","PRINCIPAL_INVESTIGATOR",{"lat":121,"lon":122},34.05223,-118.24368,{"facility":124,"status":8,"city":125,"state":126,"zip":127,"country":112,"contacts":128,"geoPoint":133},"Henry Ford Cancer Institute","Detroit","Michigan","48202",[129,131],{"name":130,"role":116},"Dalia Abdullah",{"name":132,"role":119},"Bindu R Potugari, M.D.",{"lat":134,"lon":135},42.33143,-83.04575,[137],{"name":138,"role":116,"phone":139,"email":140},"Louis M Scarmoutzos, Ph.D.","617-283-2182","lou@scitechdevelopment.com",[142],{"name":143,"affiliation":13,"role":144},"Ali Moiin, MD","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":148,"biomarkers":150},[149],"Lung Small Cell Carcinoma",[],{"nct_id":4,"found":152,"summary":153,"prompt_version":163},true,{"design":154,"status":155,"heading":156,"summary":157,"follow_up":158,"word_count":159,"commitments":160,"compensation":161,"drugs_mentioned":162},"This is a Phase 1 interventional study, meaning it's an early-stage trial to test a new treatment. It plans to enroll 44 participants.","completed","Phase 1 Trial of ST-001 nanoFenretinide for Small Cell Lung Cancer","This study is testing a new form of a drug called ST-001 nanoFenretinide, which uses tiny particles (nanoparticles) to deliver the medicine, for people with small cell lung cancer (SCLC). This drug works by using an immunotherapy mechanism. You may be able to join if you have SCLC that has come back or hasn't responded to previous treatments, including platinum-based chemotherapy, and you have at least one measurable tumor. The main goal is to see how long people live without their cancer growing (progression-free survival) when treated with ST-001. The study is currently unclear about its recruitment status and plans to enroll 44 participants.","The primary endpoint, progression-free survival, is measured from enrollment to the end of treatment, which is 3 weeks.",104,"Not specified in the trial record.","Not stated in the trial record.",[38],"v2"]