Phase 3 Ovarian Cancer Trial, By Invitation NCT05645536 Sponsor: Tolmar Inc. Condition: Ovarian Cancer
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Phase 3 Ovarian Cancer Trial, By Invitation

NCT05645536
By Invitation 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:

For women:

  • You must have already completed the Week 48 visit (Visit 9) of the TOL2506A study and be considered suitable to continue hormone therapy with ovarian suppression
  • You must be able to understand what this study involves and sign a consent form agreeing to take part
  • You must be between 18 and 51 years old (inclusive)

For men:

  • You must have already completed the Week 48 visit (Visit 9) of the TOL2506A study and be considered suitable to continue hormone therapy with GnRH agonist treatment
  • You must be able to understand what this study involves and sign a consent form agreeing to take part

Who may not be able to join:

For women and men (shared criteria):

  • You are underweight, with a body mass index (BMI) below 18 (a measure of weight relative to height)
  • Your doctors estimate you have less than 12 months to live
  • Your general health and ability to carry out daily activities is severely limited (confirm with trial site)
  • Your liver is not working well enough, based on blood tests showing certain liver-related values are too high, or you have severe liver disease
  • Your kidneys are not working well enough, based on blood tests or urine tests showing poor kidney function
  • Your heart electrical activity (measured by a heart tracing test called an ECG) shows an abnormally fast heart rate, or irregular electrical patterns (confirm with trial site)
  • You have started taking any new medications known to affect the heart's electrical rhythm
  • You have developed any new physical or mental health condition, addiction, or other disorder that the study doctor believes could interfere with your participation or make it unsafe to continue the study treatment
  • You have developed new problems tolerating the study drug TOL2506 that would prevent you from continuing treatment

Additional criteria for women only:

  • You are currently taking certain hormonal medications, including oral or skin patch hormone therapy, estrogen, progesterone, androgens, or hormonal contraceptives
  • You are sexually active with a male partner and are not willing to use at least two non-hormonal methods of contraception throughout the study
  • You could become pregnant and your pregnancy test at screening comes back positive

Additional criteria for men only:

  • You are currently taking oral or skin patch hormone therapy

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 9 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.

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Trial details

Status
By Invitation
Phase
Phase 3
Sponsor
Tolmar Inc.
Registry
ClinicalTrials.gov
Start date
28 December 2022
Est. completion
1 June 2028

Where this trial is recruiting

🇦🇷 Argentina 🇧🇷 Brazil 🇮🇳 India 🇲🇽 Mexico Puerto Rico 🇺🇸 United States

Primary endpoints

The occurrences of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

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: 9 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