Phase 1 Ovarian Cancer Trial, Recruiting NCT06430541 Sponsor: University of Colorado, Denver Condition: Ovarian Cancer
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Phase 1 Ovarian Cancer Trial, Recruiting

NCT06430541
Recruiting Phase 1

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:

  • You are 21 years of age or older
  • You have been diagnosed with early-stage breast cancer (stage 1 or 2) that is considered low risk, finished your main treatments (surgery, chemotherapy, and/or radiation) more than 6 months ago, and your oncologist estimates your chance of the cancer coming back within 10 years is less than 20%
  • OR you have been diagnosed with late-stage ovarian cancer (stage 3 or 4) that is considered high risk, you are currently in remission, and your oncologist estimates your chance of the cancer coming back within 10 years is more than 80%
  • You are generally well enough to carry out light activity and daily self-care (confirm with trial site for specific fitness standards)
  • You are able to swallow and take medication by mouth
  • You are experiencing fear of your cancer coming back, both at the screening appointment and at the start of the study
  • You have someone in your life who can accompany you home (or to another safe place) after each study dose
  • If you are able to become pregnant, you agree to use reliable birth control throughout the study

Who may not be able to join:

  • You have unstable or serious health conditions such as heart failure, certain heart rhythm problems, a recent heart attack, severely high blood pressure, kidney failure, severe liver problems, or breathing failure (confirm with trial site for full list)
  • Your blood pressure at screening or at the start of the study is higher than 140/90 mmHg
  • You have a significant brain or nervous system condition, such as epilepsy, a history of stroke, a brain tumour, a brain aneurysm, or dementia
  • You have, or have had in the past, a serious mental health condition such as schizophrenia, schizoaffective disorder, bipolar disorder, or depression with psychotic features
  • A close biological relative (such as a parent or sibling) has been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder with psychotic features
  • The study team believes, based on their clinical judgement, that you may be at risk of an unsafe emotional or behavioural reaction, such as severe agitation or violent behaviour
  • You have had a moderate or severe alcohol or drug use problem within the past year (excluding caffeine and nicotine)
  • You have used hallucinogenic substances such as LSD or psilocybin (magic mushrooms) in the last 12 months, or more than 25 times in your lifetime
  • You have had significant thoughts of suicide or self-harm recently, as assessed using a standard clinical questionnaire (confirm with trial site for specific details)
  • You have a history of a condition called hallucinogen persisting perception disorder (HPPD), where visual disturbances continue long after using a hallucinogenic substance
  • You are currently pregnant or breastfeeding
  • You show signs of significant memory or thinking difficulties, as measured by a standard cognitive test (confirm with trial site for specific score threshold)
  • You are currently taking certain medications, including antidepressants, antipsychotics, mood stabilisers, certain herbal supplements (such as St. John's Wort), or several other specific drugs (confirm with trial site for the full list)
  • You test positive for certain drugs in a urine test at the time of screening (unless the medication has been prescribed to you)
  • The study team judges that a mental health condition would make it unsafe or unsuitable for you to participate
  • The study team identifies any other physical symptom, medication, or finding that makes you unsuitable for the study, based on their clinical judgement
  • You have a known allergy or intolerance to any ingredient in the study drug
  • You do not speak English
  • You are currently enrolled in another clinical trial focused on treating anxiety, depression, or emotional distress

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 13 July 2026
Phase 1: approximately ~10% 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: Stacy Fischer, MD, University of Colorado, Denver

Phone: 303-724-5729

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 1
Registry
ClinicalTrials.gov
Start date
21 November 2024
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Fear of Cancer Recurrence Inventory

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: 13 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