Phase 3 Ovarian Cancer Trial, Recruiting NCT05804370 Sponsor: NX Development Corp Condition: Ovarian Cancer
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Phase 3 Ovarian Cancer Trial, Recruiting

NCT05804370
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with, or are strongly suspected of having, primary ovarian cancer, peritoneal cancer, or fallopian tube cancer, or who have recurring ovarian cancer, and are scheduled for surgery to remove as much tumour as possible.
  • People who have had an MRI, PET, or CT scan within the last 30 days that shows a suspected tumour or tumour recurrence for which debulking surgery has been planned.
  • Women aged 18 years or older.
  • People who have healthy organ and bone marrow function and have been assessed as suitable candidates for surgery at the trial site.
  • People whose liver and kidney blood test results fall within the acceptable ranges required by the trial (confirm specific values with the trial site).
  • People who are able to understand the consent documents (available in English and Spanish, with translation support provided where needed) and are willing to sign a written consent form.
  • Women who are able to become pregnant must agree to use highly effective contraception for at least 42 days after receiving the single study drug dose.

Who may not be able to join:

  • People whose surgery is planned as a laparoscopy only, where the surgeon considers it unlikely that open surgery or tumour removal will take place.
  • People who have a known allergy or sensitivity to aminolevulinic acid (ALA) or porphyrins (substances related to the study drug).
  • People who have any form of porphyria (a group of conditions affecting how the body processes certain natural chemicals).
  • People who have an uncontrolled serious illness, including active infection, heart failure, unstable chest pain, irregular heart rhythm, or an uncontrolled psychiatric condition.
  • People who have received chemotherapy, tumour removal surgery, or radiation treatment within 21 days before the planned surgery.
  • People whose personal or medical circumstances may make it difficult to follow the study requirements, such as being unable to attend follow-up appointments or having been unable to have the required pre-operative scan.
  • People who are pregnant or plan to become pregnant during the study.
  • People who have participated in another investigational treatment trial within 21 days before or after receiving the study drug.
  • People who are taking certain medications or supplements that may increase sensitivity to light — including St. John's Wort, some antibiotics, water tablets, or diabetes medications — or who are using any skin products containing ALA, within 24 hours around the time of surgery (confirm the full list with the trial site).
  • People who are unwilling to sign the consent form or return for follow-up visits after surgery.
  • People who, in the opinion of the trial investigator, have any other condition that makes them unsuitable for the study.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Kristina Butler, MD, Mayo Clinic

Phone: 512-348-3885

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
NX Development Corp
Registry
ClinicalTrials.gov
Start date
30 May 2024
Est. completion
1 September 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To determine the clinical usefulness of Gleolan to detect epithelial ovarian cancer tissue not detected during SoC debulking surgery.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov