Phase 1 Multiple Sclerosis 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:

• Adults aged 18 or older at the time of giving consent to participate.
• Women in Cohort A (hormone receptor-positive, HER2-negative breast cancer) must be postmenopausal, meaning they have not had a menstrual period for 12 or more consecutive months without another medical explanation.
• People in Cohort B (kidney cancer, neuroendocrine tumors, tuberous sclerosis-related tumors, or liver cancer) can be male or female adults with advanced disease.
• Cohort A participants must have advanced (spread or inoperable) hormone receptor-positive, HER2-negative breast cancer that is Stage IV or locally advanced, and must have already tried hormone-based treatments that stopped working, or had a cancer return within 6 months of completing chemotherapy.
• Cohort B participants must have a confirmed diagnosis of one of the listed cancer types that has spread or cannot be removed by surgery, and must have already tried at least one standard treatment that did not work or was not tolerated (unless no standard treatment exists for that cancer type).
• Participants must currently be taking stable doses of metformin or a statin medication.
• Participants must have a general health status rated at 2 or below on the ECOG scale, meaning they are able to carry out some daily activities (confirm with trial site).
• Participants must have a life expectancy of at least 3 months.
• Participants must have blood counts, kidney function, and liver function that meet specific minimum levels on tests done within 7 days before joining (confirm details with trial site).
• Other routine blood test results must be considered normal or not medically concerning by the lead doctor.
• Participants must not be breastfeeding, and breastfeeding must stop before the first dose of the study drug.
• Women who could become pregnant must use effective contraception during the study and for 8 weeks after the last dose; men with female partners who could become pregnant must use effective contraception during the study and for 4 weeks after the last dose.
• Participants must be willing and able to follow all study requirements and attend all study visits.
• Participants must be able to understand the nature of the study, as assessed by the clinic staff.

Who may not be able to join:

• People with a history of another cancer, unless it was adequately treated non-melanoma skin cancer, cervical cancer in situ that was cured, breast cancer in situ that was cured, or another cancer that was cured with no signs of return for more than 5 years.
• People who have not fully recovered from side effects of previous cancer treatments (such as chemotherapy, hormone therapy, immunotherapy, targeted therapy, or radiation), where those side effects are still rated at Grade 1 or above — except for hair loss.
• People who received chemotherapy within the past 30 days (or 42 days for certain specific drugs), or immunotherapy, anti-tumour hormone therapy, or radiotherapy within the past 30 days.
• People who had major surgery within the past 30 days, or who have not yet fully recovered from a previous major surgery.
• People experiencing nerve damage or numbness (peripheral neuropathy) rated above Grade 1 at the time of screening (confirm with trial site).
• People with active brain metastases (cancer that has spread to the brain and is currently active); people whose brain metastases have been treated and show no active disease, and who have been off all related treatments including steroids for at least 3 months, may still be considered.
• People with any other significant ongoing medical condition beyond cancer, including serious heart, liver, kidney, lung, neurological, psychiatric, immune, or blood-related conditions, unless the lead doctor determines it is not clinically significant.
• People with a history of difficulty donating blood or problems with accessing a central line (a type of intravenous line used during treatment).
• People with a known history of HIV, Hepatitis B, or Hepatitis C (blood tests to confirm absence are required within 7 days before joining).
• People with a history of alcohol abuse or dependence within the past year.
• People with a current history of dependence on drugs such as marijuana, amphetamines, barbiturates, cocaine, opiates, or benzodiazepines.
• People with a known allergy or sensitivity to everolimus, similar drugs (rapamycin derivatives), or their ingredients.
• People with a history of severe allergic reactions such as anaphylaxis or severe swelling (angioedema).
• People who are currently participating in another clinical trial involving experimental treatments or investigational devices, or who have done so within the past 30 days.
• People who have taken certain strong medications that affect how the body processes drugs (specific CYP enzyme inhibitors or inducers, such as fluconazole, ketoconazole, rifampin, or carbamazepine) within the 14 days before joining and throughout the study (confirm full list with trial site).
• People who have an active infection currently being treated with antibiotics, antiviral, or antifungal medications within the past 14 days.
• People who are pregnant or breastfeeding.

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