Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)

• Status: Not yet recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

This Phase 3 study is designed to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan (aminolevulinic acid hydrochloride, also referred to as ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real-time detection and visualization of de novo or recurrent epithelial ovarian cancer during tumor debulking.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NX Development Corp
• Treatments: Aminolevulinic Acid

Criteria

Inclusion Criteria:

1. Study will be limited to patients with the following diagnoses who plan to undergo surgical cytoreduction or interval debulking: a. primary diagnosis or high clinical suspicion of primary epithelial ovarian cancer, b. suspected epithelial, peritoneal, or fallopian tube cancer, c. recurrent epithelial ovarian cancer.

Note: participants with a diagnosis of (a) or (b) may be treatment-naïve or have received neoadjuvant therapy, as clarified in Exclusion Criteria 6 and 9.

2. A pre-operative magnetic resonance image (MRI), positron emission tomography (PET), or computed tomography (CT) ≤ 30 days of study enrollment documenting a suspected tumor or suspected recurrence of tumor for which surgical debulking is indicated and has been planned.

3. Females (only) age ≥ 18 years.

4. Study participants must have normal organ and bone marrow function and be appropriate surgical candidates per site SoC.

5. Study participant must have recording of each parameter as defined below:

Bilirubin: Below upper limit of normal AST (SGOT): < 2.5 X institutional upper limit of normal ALT (SGPT): < 2.5 X institutional upper limit of normal Creatinine: Below upper limit of normal OR Creatinine clearance: >60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal

6. The study subject t must demonstrate the ability to understand the informed consent document and the willingness and ability to sign a written informed consent document. The study consent documents will be prepared in English and Spanish. Translation for non-English speaking participants will be provided as appropriate by institution, as required.

7. Women of childbearing potential must agree to use highly effective forms of contraception for at least 42 days after the one-time use of the Gleolan study drug.

Exclusion Criteria:

1. Patient is to undergo laparoscopy and their surgeon believes it is unlikely that laparotomy/debulking will occur.

2. Hypersensitivity to aminolevulenic acid (ALA) or porphyrins.

3. Acute or chronic types of porphyria.

4. Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness.

5. Patient has had chemotherapy, tumor resection or radiation treatment within 21 days prior to surgery.

6. Social or medical situations that would limit compliance with study requirements (e.g. ability to travel for follow-up or inability to obtain appropriate pre-op MRI, PET, or CT.

7. Women who are pregnant or plan to become pregnant during study participation.

8. Simultaneous participation in another investigational treatment trial in the 21 days directly preceding or after study drug administration.

9. Simultaneous use of other potentially phototoxic substances (e.g., St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines), and topical preparations containing ALA for 24 hours during the perioperative period.

10. Unwillingness by study participant to sign consent or return for subsequent visits following surgery.

11. Any condition that in the opinion of the Investigator would exclude the study participant as a viable candidate for this study.