Phase 1 Ovarian Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People diagnosed with ovarian, fallopian tube, or primary peritoneal cancer that has come back more than 6 months after finishing their last platinum-based chemotherapy treatment, and whose cancer is considered suitable for platinum-based chemotherapy again.
• People whose cancer has been confirmed to have returned or grown, based on standard imaging and assessment criteria.
• People who have had at least one previous course of platinum-based chemotherapy; prior treatment with bevacizumab or PARP inhibitors is also allowed (note: people with a BRCA gene mutation should discuss standard PARP inhibitor maintenance treatment with their doctor before considering this trial).
• People who are reasonably active and able to care for themselves, with a general health score of 0–2 on a standard medical scale, and a life expectancy of at least 3 months.
• People whose kidneys, liver, and blood counts are functioning within acceptable ranges, as measured by specific laboratory tests (confirm details with trial site).
• People who are able to swallow a tablet or liquid form of the study drug (CPI-0209).
• People who are able to give informed consent and follow all study requirements.
• People who have had cancer spread to the brain, provided that treatment for this was completed at least 8 weeks before joining the trial, they are not experiencing symptoms, have not needed steroid medications for at least 4 weeks after radiation, and repeat scans show the brain disease is stable or has reduced.
• People who are able to become pregnant (defined as having had a menstrual cycle in the last year and not having had both ovaries removed or a hysterectomy) must agree to use a highly effective method of contraception, or abstain from vaginal intercourse, for at least 183 days after stopping the study treatment.

Who may not be able to join:

• People whose cancer is classified as borderline or low malignant potential.
• People whose cancer returned or grew within 6 months of finishing platinum-based chemotherapy (considered platinum-resistant).
• People with a known allergy or sensitivity to any ingredient in the study drug CPI-0209.
• People with digestive system problems that could significantly affect how the study drug is absorbed by the body.
• People who currently have, or have had, another cancer within the past 3 years — with some exceptions, such as certain treated skin cancers or cervical cancer treated with curative intent (the trial team will assess on a case-by-case basis).
• People with a known history of HIV infection.
• People who currently have an active infection that requires treatment with systemic medication.
• People with other serious or uncontrolled medical conditions that the investigator believes would make participation unsafe or affect ability to follow the study protocol (such as certain heart, lung, liver, or pancreatic conditions, or uncontrolled infections).
• People currently taking warfarin or similar blood-thinning medications derived from coumadin; certain other blood thinners such as heparin or fondaparinux are allowed.
• People using herbal supplements that have not been stopped at least 7 days before starting the study drug.
• People who are unwilling to stop eating grapefruit, grapefruit juice, or Seville oranges — or foods containing these — from the time of joining the trial through the end of participation, as these can affect how the study drug works.
• People who are pregnant or breastfeeding.
• People who have participated in another clinical trial within 30 days before joining, or within 5 half-lives of the previous trial drug, whichever is longer.
• People who have had radiotherapy within the past 4 weeks (or limited palliative radiation within 2 weeks) and have not recovered sufficiently from its side effects, or where a large portion of their bone marrow was in the radiation field.
• People who have had major surgery within 14 days before starting the study drug, or who have not recovered from major surgery.
• People who still have significant side effects (above a mild level) from previous cancer treatments, with some exceptions such as hair loss, mild nerve-related symptoms, or well-controlled hormonal side effects.
• People with severe nerve damage (grade 3 neuropathy) prior to starting the trial.
• People with significantly reduced liver function, classified as Child-Pugh score B or C (confirm with trial site).

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