Gleolan for Ovarian Cancer

Recruiting at 4 trial locations

Overseen By Kristina Hadley, MSN, RN

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: NX Development Corp

Must not be taking: Phototoxic substances

Disqualifiers: Porphyria, Uncontrolled illness, Pregnancy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

170 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Gleolan, a drug used during surgery to help doctors see ovarian cancer tumors more clearly. The goal is to assess the safety and usefulness of Gleolan for spotting these tumors in real-time. This could enhance the effectiveness of surgery for patients with suspected or confirmed ovarian, peritoneal, or fallopian tube cancer. Women scheduled for surgery for these conditions, who have had a recent scan showing a suspected tumor, might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in cancer surgery.

Will I have to stop taking my current medications?

The trial requires participants to stop using certain phototoxic substances (medications that make the skin sensitive to light) like St. John's wort and some antibiotics for 24 hours during the perioperative period (around the time of surgery). Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

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

Research has shown that Gleolan, also known as aminolevulinic acid hydrochloride, already has FDA approval for surgeries like brain surgery, indicating prior safety testing in humans. In earlier studies involving 527 patients, Gleolan was generally well-tolerated. Some side effects occurred, typically mild to moderate, such as nausea and changes in vision, like seeing colors. Most participants did not experience serious issues. Although this trial will focus on ovarian cancer, previous data suggests that Gleolan is likely safe for use in surgeries. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ovarian cancer?

Unlike the standard treatments for ovarian cancer, which typically involve surgery, chemotherapy, and sometimes targeted therapies, Gleolan offers a novel approach by enhancing intraoperative imaging. Gleolan is unique because it acts as a fluorescent agent that helps surgeons better visualize cancerous tissue during surgery, potentially leading to more precise tumor removal. Researchers are excited about Gleolan as it could improve surgical outcomes and reduce the likelihood of cancer recurrence by ensuring a more thorough and accurate excision of cancerous tissues.

What evidence suggests that Gleolan is effective for detecting ovarian cancer?

Research has shown that Gleolan helps doctors see ovarian cancer tumors more clearly during surgery. One study found that Gleolan highlighted areas that might otherwise be missed, making tumor removal easier. This enables doctors to perform more thorough surgeries, potentially leading to better patient outcomes. Early trials demonstrated improved response and survival rates, although long-term survival remains a challenge. Overall, Gleolan aids in identifying more cancer spots, potentially making surgeries more effective. ^{3 4 6 7 8}

Who Is on the Research Team?

Kristina A. Butler, M.D.

Principal Investigator

Mayo Clinic

John McBroom, MD

Principal Investigator

Luminis Health

Are You a Good Fit for This Trial?

This trial is for patients with a new or returning diagnosis of epithelial ovarian cancer who are scheduled for surgery to remove the tumor. It includes those who may be treatment-naïve or have had prior therapy, specifically targeting primary epithelial ovarian, peritoneal, or fallopian tube cancers.

Inclusion Criteria

I am diagnosed with or suspected to have ovarian, peritoneal, or fallopian tube cancer and plan to have surgery to remove it.

I may or may not have received initial treatment for my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Part A1 - Training

Open-label training phase to optimize workflow and collect data on tumor-to-background ratio using Gleolan-induced fluorescence

1 week

1 visit (in-person)

Part A2 - Training

Open-label training phase to optimize workflow and obtain data for sample size estimation for Part B

1 week

1 visit (in-person)

Part B - Randomized Pivotal

Evaluation of safety, diagnostic performance, and clinical usefulness of Gleolan for real-time detection and visualization during debulking surgery

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Gleolan

Trial Overview The study tests Gleolan's ability to help surgeons see and remove ovarian cancer tumors in real-time during debulking surgery. This Phase 3 trial will assess its safety, diagnostic accuracy, and clinical value over an approximate period of 18 months with two weeks of individual participation.

How Is the Trial Designed?

Group I: Patients Receiving Gleolan Experimental Treatment 1 Intervention

All patients in this arm will receive Gleolan and undergo intraoperative imaging

Who Is Running the Clinical Trial?

NX Development Corp

Lead Sponsor

Trials

4

Recruited

330+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10749305/

Optimized complete cytoreduction in ovarian cancer ... Intraoperative administration of 5-ALA led to improved complete cytoreduction by identification and resection of additional ovarian cancer tumor manifestations.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05804370

Study Details | NCT05804370 | Gleolan for Visualization of ... This Phase 3 study is designed to investigate the safety, diagnostic performance, and clinical usefulness of Gleolan for the real-time detection and ...

3. mayo.edu mayo.edu/research/clinical-trials/cls-20557236

Gleolan for Visualization of Newly Diagnosed or Recurrent ... The purpose of this study is to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan ( ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7005471/

Review of clinical trials in intraoperative molecular imaging ... The primary study objective is to confirm the efficacy of IMI in detecting additional ovarian cancer lesions that are not detected by standard- ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1011134401001798

Effects of 5-aminolaevulinic acid on human ovarian cancer ... These initial trials have resulted in improved response and survival rates, but patients are rarely cured and only about 30% will survive 5 years after ...

6. gleolan.com gleolan.com/hcp

Health Care Professional Gleolan (aminolevulinic acid HCl) is the first and only FDA-approved optical imaging agent for use during fluorescence-guided surgery (FGS) in patients with ...

7. fda.gov fda.gov/drugs/resources-information-approved-drugs/aminolevulinic-acid-hydrochloride-known-ala-hcl-gleolan-nx-development-corp-optical-imaging-agent

Aminolevulinic acid hydrochloride, known as ALA HCl ... 38% in the control arm, with the difference of 26% (95% CI: 16%, 36%). The safety of ALA is supported by 5 clinical trials that included 527 ...

8. ema.europa.eu ema.europa.eu/en/documents/product-information/gliolan-epar-product-information_en.pdf

Gliolan, INN-5-aminolevulinic acid hydrochloride - EMA Summary of the safety profile. Adverse reactions observed after the use of this medicinal product for fluorescence-guided glioma resection are divided into the ...