FL118 for Pancreatic Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Roswell Park Cancer Institute

Must not be taking: Mitomycin C, Nitrosourea

Disqualifiers: Organ transplant, Heart failure, others

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

Compensation: Varies

Number of Visits: 5

Duration: 28 days per cycle, repeated

Trial Summary

What is the purpose of this trial?

This phase I trial tests the safety, side effects, and best dose of FL118 in treating patients with pancreatic ductal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). FL118 is a small anti-tumor molecule that inhibits the expression of multiple cancer-associated anti-apoptotic proteins. An anti-apoptotic protein is a protein that interferes with or inhibits cell death. In adults, apoptosis is used to rid the body of cells that have been damaged beyond repair. Apoptosis also plays a role in preventing cancer. If apoptosis is for some reason prevented, it can lead to uncontrolled cell production that can subsequently develop into a tumor. FL118 has been shown to inhibit or block the proteins that prevent damaged/mutated (genetically changed) cells from dying, and, by doing so, prevent the growth of cancerous cells and tumor development.

Research Team

Christos Fountzilas, MD, FACP

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

This trial is for adults with advanced pancreatic ductal adenocarcinoma, which may have spread. Participants should be able to undergo procedures like biopsies and imaging scans. Specific eligibility criteria are not provided, but typically include factors like overall health status and prior treatments.

Inclusion Criteria

Life expectancy of greater than 3 months

Use of highly effective contraception for females of reproductive potential and use of condoms or other methods for males of reproductive potential

My cancer got worse or I couldn't tolerate my first treatment for advanced disease.

Exclusion Criteria

I have not had a bowel obstruction or perforation in the last 3 months.

I am currently on medication for an infection.

I have had an organ transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive FL118 orally on days 1, 8, and 15 of each 28-day cycle. Blood samples and imaging are conducted throughout the trial.

28 days per cycle, repeated

3 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and then every 3 months for up to 12 months.

12 months

1 visit at 30 days, then every 3 months

Treatment Details

Interventions

• FL118

Trial Overview The trial is testing the safety and optimal dosage of FL118, a molecule designed to block certain proteins that prevent cell death. By inhibiting these proteins, FL118 aims to stop cancer cells from multiplying and forming tumors.

Participant Groups

Group I: Treatment (FL118) Experimental Treatment 5 Interventions

Patients receive FL118 PO on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples and CT or MRI throughout the trial. Patients may optionally undergo biopsy at screening and on study.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+