Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/ Refractory Small Cell Lung Cancer
ConditionSmall Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSciTech Development, Inc.
About this trial
This study evaluates a fenretinide phospholipid suspension for the treatment of small cell lung cancer (SCLC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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/refractory disease of any stage if incurable in nature, is eligible for enrollment.
Disqualifiers
Mixed SCLC/NSCLC 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.
Trial design
Design model
Sequential
Treatments tested in this trial
Fenretinide
DrugIntravenous administration
Fenretinide
DrugIntravenous administration
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Standard Phase 1aExperimental treatment 1 intervention
Group B: Expanded Phase 1bExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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/mL) 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.
Time frame
From enrollment to end of treatment is 3 weeksSecondary outcomes
1
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
Time frame
From enrollment to end of treatment is 3 weeks2
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.
Time frame
From enrollment to end of treatment is 3 weeks3
Objective Response Rate (ORR)
ORR = (Number of patients with complete or partial response) / (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.
Time frame
From enrollment to end of treatment is 3 weeks4
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).
Time frame
From enrollment to end of treatment is 3 weeksSponsors and contacts
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Source ClinicalTrials.gov