Health Trials

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

Qualifiers

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.

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

Treatments tested in this trial

  • Fenretinide
  • Fenretinide

Treatment groups

44 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

University of Southern CaliforniaRecruiting90007, Los Angles, CaliforniaUnited StatesUnited States

Sponsors and collaborators

SciTech Development, Inc.

Lead sponsor

Source ClinicalTrials.gov