Gleolan for Ovarian Cancer Surgery

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

Recruiting Phase 3 Interventional Study
Ovarian Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Diagnostic
Participants needed
170 (estimated)
Sponsor
NX Development Corp · Industry
Who this trial is looking for

This trial is looking for women with ovarian cancer who will have surgery to remove tumors. Participants will take a drug called Gleolan before their surgery to help doctors see the cancer better.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with ovarian cancer or have a suspected tumor.
  • I plan to have surgery to remove the tumor.
  • I am a woman aged 18 or older.
  • I have had an MRI, PET, or CT scan within the last 30 days showing a tumor.
  • I have normal organ and bone marrow function.
  • I can understand and sign the consent form.
  • I will use effective contraception if I can become pregnant.

You may not be able to join if

  • I will have a laparoscopy instead of debulking surgery.
  • I am allergic to aminolevulinic acid or similar substances.
  • I have porphyria, either acute or chronic.
  • I have a serious ongoing illness.
  • I have had chemotherapy, surgery, or radiation within the last 21 days.
  • I have a situation that makes it hard for me to follow study requirements.
  • I am pregnant or planning to become pregnant during the trial.
  • I am participating in another trial or taking substances that make the study drug unsafe.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial

This Phase 3 study is designed to investigate the safety, diagnostic performance, and clinical usefulness of Gleolan for the real-time detection and visualization of epithelial ovarian cancer tumors during debulking surgery. The study is planned to run for about 18 months with individual study participation lasting about two (2) weeks.

Trial Locations
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Eligibility 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…
Contacts

Michael Giammona

512-348-3885

mgiammona@nxdevcorp.com

CONTACT

Ron Mims

505-681-3537

rmims@nxdevcorp.com

CONTACT