Fenretinide for Small Cell Lung Cancer

Overseen By Louis M Scarmoutzos, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: SciTech Development, Inc.

Must not be taking: CYP3A inducers, CYP3A inhibitors

Disqualifiers: Mixed SCLC/NSCLC, CNS metastasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of a new treatment, fenretinide, for small cell lung cancer (SCLC). The goal is to determine the safe dose and evaluate its effectiveness for individuals whose cancer has returned or stopped responding to other treatments. It suits those previously treated with radiation or chemotherapy and who have at least one measurable tumor. Participants should have small cell lung cancer without a mix of other types and have experienced treatment failure or relapse. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot take part if you need drugs that strongly affect certain liver enzymes (CYP3A inducers or inhibitors). Also, if you are on HIV medication or have certain eye conditions, you may not be eligible.

Is there any evidence suggesting that fenretinide is likely to be safe for humans?

Research has shown that fenretinide is generally safe for humans. It was tested in over 3,000 women for breast cancer prevention and proved to be safe. Researchers are now studying it for small cell lung cancer (SCLC).

Studies indicate that fenretinide can effectively target and kill cancer cells. However, concerns exist about its absorption in the body. Some patients have experienced side effects that limit their dosage.

The FDA approved fenretinide for further study in SCLC after a thorough safety review, confirming it passed safety checks for human testing. While this is reassuring, it's important to remember that every treatment can have side effects, and responses may vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Fenretinide is unique because it offers a new approach to treating small cell lung cancer by utilizing its active ingredient, a synthetic derivative of vitamin A. Unlike standard chemotherapy options, which often target rapidly dividing cells indiscriminately, fenretinide specifically induces cancer cell death through a process called apoptosis. Researchers are excited about this treatment because it has the potential to be more targeted and less toxic than existing therapies, potentially leading to fewer side effects for patients. Additionally, its novel mechanism of action might offer hope for those who have not responded well to traditional treatments.

What evidence suggests that fenretinide might be an effective treatment for small cell lung cancer?

Research has shown that fenretinide has potential as a cancer treatment. In earlier studies, patients with small cell lung cancer (SCLC) generally tolerated fenretinide well, and about 24% experienced disease stabilization, meaning their cancer did not worsen. However, poor absorption by the body has sometimes reduced its effectiveness. In this trial, participants will receive a new version, ST-001, designed to improve absorption through a special suspension. Overall, this new approach could lead to better outcomes for people with SCLC. ^{1 3 4 6 7}

Who Is on the Research Team?

Ali Moiin, MD

Principal Investigator

SciTech Development, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with small cell lung cancer (SCLC) who have relapsed or are not responding to treatment. They must have had prior treatments like radiation or chemotherapy, be in fairly good health with a life expectancy over 6 months, and their body should be functioning well after previous treatments. Women eligible must not be able to bear children.

Inclusion Criteria

I have small cell lung cancer.

* Patients must all have at least one measurable disease site using RECIST version 1.1 criteria.

I have had radiation or platinum-based chemotherapy, with or without immunotherapy, for my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ST-001 via 4-hour IV infusion daily for five consecutive days, every 3 weeks

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fenretinide

Trial Overview The study is testing ST-001 nanoFenretinide, a new form of the drug fenretinide suspended in phospholipids, as a potential treatment for SCLC that has come back or isn't responding to standard therapies.

How Is the Trial Designed?

Group I: Standard Phase 1a Experimental Treatment 1 Intervention

During the Standard Phase 1a, three patients are enrolled into each dose level cohort and the three patients must be evaluated for cycle 1 toxicity before the decision can be made to open the next higher dose level.

Group II: Expanded Phase 1b Experimental Treatment 1 Intervention

Expansion of the dose-finding Phase 1a to determine the safety and maximum tolerated dose (MTD) of the investigative drug product (ST-001).

Who Is Running the Clinical Trial?

SciTech Development, Inc.

Lead Sponsor

Trials

1

Recruited

50+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06922539

ST-001 nanoFenretinide in Relapsed/ Refractory Small ... Fenretinide has been shown to be a relatively safe and effective anticancer therapy; however, low fenretinide bioavailability and dose limiting toxicities ...

2. cancernetwork.com cancernetwork.com/view/fda-accepts-ind-application-for-st-001-in-relapsed-refractory-sclc

FDA Accepts IND Application for ST-001 in Relapsed ... The FDA has approved an investigational new drug application (IND) for ST-001, a novel fenretinide phospholipid suspension, as an intravenous therapy for ...

3. targetedonc.com targetedonc.com/view/fda-clears-ind-application-for-st-001-in-sclc

FDA Clears IND Application for ST-001 in SCLC ST-001, an intravenous nanoformulation of fenretinide, will be evaluated in a phase 1a/1b small cell lung cancer trial.

4. scitechsdp.com scitechsdp.com/scitech-development-announces-2nd-fda-approval-of-a-phase-1-a-b-ind-for-st-001-new-ind-targets-the-treatment-of-relapsed-refractory-small-cell-lung-cancer-following-its-previous-approval-in-the-treat/

SciTech Development Announces 2nd FDA Approval of a ... The US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for “A Phase 1a/b Trial in Relapsed/Refractory Small Cell ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19225720/

Phase II Trial of Fenretinide (NSC 374551) in Patients With ... Fenretinide is well tolerated in patients with SCLC and stabilization of disease was noted in 24% of patients with this aggressive disease.

6. scitechdevelopment.com scitechdevelopment.com/the-product

Lead Drug Product | ST-001 nanoFenretinide There is ample evidence in the scientific literature that demonstrates that fenretinide is cytotoxic and destroys cancer cells by inducing apoptosis (programmed ...

7. nfcr.org nfcr.org/translational-research/scitech/

ST-001 Fenretinide, a synthetic small-molecule which has been clinically tested as a breast cancer prevention drug in more than 3,000 women, has been shown to be safe ...