Phase 1 Prostate Cancer Trial, Completed

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 who are reasonably active and able to care for themselves (rated 0 or 1 on a standard activity scale used by doctors)
• People with a life expectancy of at least 3 months
• People who are able to swallow tablets or capsules
• People whose blood counts fall within acceptable ranges — including white blood cells, platelets, and red blood cells — tested within 28 days before starting treatment, without having needed a blood transfusion in the prior 28 days
• People whose liver, kidney, and other organ function test results fall within acceptable ranges, tested within 28 days before starting treatment
• People whose fasting blood sugar is no higher than 150 mg/dL and whose longer-term blood sugar marker (HbA1c) is no higher than 7.5%
• People whose side effects from any previous cancer treatments have settled down to a mild level (except for hair loss or nerve-related symptoms)
• People with a confirmed diagnosis of ovarian cancer, breast cancer, or prostate cancer (note: breast and ovarian cancer patients may only join Part 1 of the trial; prostate cancer patients may join Part 1 or Part 2)
• People whose cancer has either spread to other parts of the body or is locally advanced and cannot be cured with current treatment
• For ovarian cancer (Part 1 only): People with a specific high-grade type of ovarian, fallopian tube, or primary peritoneal cancer who have already received at least one platinum-based chemotherapy, have a raised CA-125 blood marker (more than twice the upper normal limit), and have measurable disease on scans
• For breast cancer (Part 1 only): People with HER2-negative breast cancer (either hormone receptor-positive or triple-negative) who have received certain prior treatments, have not received more than two prior chemotherapy treatments for metastatic disease, and have measurable disease on scans
• For prostate cancer: People with a specific type of prostate cancer (adenocarcinoma, without small cell or neuroendocrine features) whose testosterone is at a very low level due to surgical or medical castration, who have shown signs of cancer progression (by PSA blood tests or scans), who have already received at least one second-generation hormone-blocking treatment (such as abiraterone or enzalutamide), and who have measurable disease on scans or bone lesions visible on a bone scan
• People who are able to provide a tumour tissue sample (a preserved tissue block or at least 12 tumour slides from the most recent biopsy) for central laboratory analysis — samples from bone metastases or fine needle aspirates are not acceptable
• People of childbearing potential who agree to use specified contraception during treatment and for at least 28 days after the last dose of ipatasertib, or 6 months after the last dose of rucaparib, whichever comes later

Who may not be able to join:

• People who are pregnant, breastfeeding, or planning to become pregnant during the study or within 28 days after the last dose of ipatasertib, or 6 months after the last dose of rucaparib
• People who have previously been treated with a PARP inhibitor, AKT inhibitor, or PI3K inhibitor (a specific group of targeted cancer drugs)
• People who have received any other experimental treatment within 14 days before starting this trial
• People who have cancer that has spread to the brain or nervous system and is causing symptoms, or has not yet been treated
• People with cancer-related pain that is not well controlled
• People who have had a minor surgical procedure within 5 days, or a major surgical procedure within 14 days, before starting the trial
• People with an active hepatitis C infection
• People with a current or past hepatitis B infection, indicated by a positive hepatitis B surface antigen or DNA test
• People with a known HIV infection
• People who, in the investigator's assessment, have misused alcohol or illicit drugs within the 12 months before screening
• People with a condition that affects the body's ability to absorb food or medication through the gut
• People who have had a serious infection requiring antibiotics within 14 days before starting treatment
• People with any serious medical condition or abnormal test results that, in the investigator's judgement, would make participation unsafe
• People who require ongoing use of corticosteroids (such as prednisone) at a dose of 10 mg per day or more, or an equivalent dose of similar anti-inflammatory or immune-suppressing medications, for a long-term condition
• People who have had another cancer within the past 5 years — with some exceptions, such as certain treated skin cancers, melanoma in situ, certain low-grade bladder cancers, or other cancers where curative treatment was received and the doctor considers the chance of return to be less than 5% over 5 years
• People with a history of significant heart or cardiovascular problems
• People with any other condition that, in the investigator's opinion, would make participation unsafe or affect the reliability of trial results
• Specific to the drug ipatasertib: People with Type 1 or Type 2 diabetes who require insulin at the time of joining the study
• Specific to ipatasertib: People with a history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) or active bowel inflammation (such as diverticulitis)
• Specific to ipatasertib: People who have taken certain strong medications known to significantly affect how the body processes drugs (called strong CYP3A inhibitors or inducers) within 4 weeks before starting the trial, or within five half-lives of that medication, whichever is longer (confirm with trial site)

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