Phase 1 Prostate Cancer Trial, Recruiting

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

Who might be able to join this trial:

Main study group:

• People who have been diagnosed with cancer of the pancreas, prostate, breast, or ovary, confirmed by laboratory testing of a tissue or cell sample.
• People whose cancer has a specific genetic change (mutation) in BRCA1, BRCA2, PALB2, or one of a long list of other related genes, confirmed by an approved laboratory report that the trial sponsor must review and approve before enrolment.

Exploratory study group (a smaller, separate group within the trial):

• People with ovarian, fallopian tube, or primary peritoneal cancer of a specific tissue type (high grade serous or high grade endometrioid), confirmed by tissue testing.
• People in this group whose cancer has a specific genetic mutation in BRCA1 or another related gene, confirmed by an approved laboratory report reviewed by the trial sponsor.
• People in this group whose cancer either did not get worse within 6 months of their last platinum-based chemotherapy (called "platinum sensitive"), or whose cancer did get worse within 6 months of that chemotherapy (called "platinum resistant").

All participants:

• People aged 18 or older.
• People who are well enough to carry out basic daily activities, as rated by a standard medical scale (ECOG score of 2 or below), assessed within 14 days of enrolling.
• People whose cancer has been shown to have progressed (gotten worse) on imaging scans within 28 days of enrolling, and whose disease can be measured using standard imaging guidelines.
• People who have at least one area of cancer that can be measured on scans.
• People whose blood test results show that their bone marrow, kidneys, and liver are functioning adequately within 14 days of enrolling — including acceptable levels of white blood cells, platelets, red blood cells, kidney function, liver enzymes, bilirubin, blood clotting factors, and protein levels (confirm specific thresholds with trial site).
• People who are willing to have a tumour biopsy before treatment starts and if/when the cancer progresses during the trial (exceptions may be made if a safe biopsy is not possible, with sponsor approval).
• People with a life expectancy of more than 3 months from the time of enrolling.
• People who are able to give written informed consent.
• People who are willing and able to follow all study requirements, including attending scheduled appointments and check-ups.
• Women who could become pregnant must have a negative pregnancy blood test within 14 days before enrolling, and again on the first day of treatment (unless the first test was done within 48 hours of enrolling).
• Women who could become pregnant, and men who are sexually active, must agree to use at least two reliable forms of contraception starting at least 14 days before enrolling, throughout the entire treatment period, and for 6 months after the last dose of the study drug.
• People who have had any number of prior cancer treatments, including prior PARP inhibitor therapy.
• People who are considered clinically stable at the time of joining the study.

Who may not be able to join:

• People with pancreatic cancer that is not the adenocarcinoma type.
• People who have a blockage in their bowel caused by cancer.
• People with brain or spinal cord tumours that are untreated or unstable (people with stable, symptom-free brain tumours who do not need steroid medication, or who have finished steroids with evidence of stability for at least 10 days, may still be considered).
• People who still have significant side effects (above a mild level) from previous cancer treatments, with the exception of certain blood-related side effects, mild to moderate nerve-related side effects, or hair loss.
• People with serious uncontrolled health conditions such as active infection, or uncontrolled breathing, heart, nerve, liver, kidney, or mental health problems that in the doctor's opinion would affect their ability to participate.
• People who have taken another experimental (non-approved) drug — other than a PARP inhibitor — within the 30 days before the first dose, or a PARP inhibitor within 14 days before the first dose.
• People with a weakened immune system, including those who are HIV-positive with a CD4+ cell count below 350 cells/uL, or those with active hepatitis B or C infection (people with previously treated and resolved hepatitis B or C may still be considered).
• People who have had major chest or abdominal surgery within 14 days before enrolling, or who have a surgical wound that has not fully healed.
• People who are receiving other systemic cancer treatments at the same time (some limited palliative radiation may be allowed — confirm with trial site).
• People who have another active cancer requiring treatment that could interfere with interpreting the trial results (each case must be discussed with the trial medical monitor).
• People with known conditions that make their skin very sensitive to sunlight (such as xeroderma pigmentosum or porphyria), or anyone who is not willing to follow strict sun protection rules — including wearing sunglasses and SPF50+ sunscreen when outdoors — during the study and for 3 months after the last dose, or who plans to use sunbeds or tanning booths during that period.
• Women who are pregnant or breastfeeding.
• People with an active eye surface disease at the time of enrolling, as confirmed by an eye specialist.
• People with a history of a specific type of scarring eye condition (cicatricial conjunctivitis), as assessed by an eye specialist.
• People who have received radiation therapy to a large area of the body, or to more than 30% of the bone marrow, within 4 weeks before the first dose (smaller palliative radiation to a limited area within 1 week before the first dose may also not be permitted — confirm with trial site).
• People whose heart's electrical activity shows a prolonged QT/QTc interval on repeated testing (above 450 ms) (confirm with trial site).
• People with a history of heart failure, low potassium levels, or a family history of a heart rhythm condition called long QT syndrome.
• People who are taking other medications known to prolong the QT/QTc interval.
• People who are taking strong medications that significantly affect how the body processes certain drugs (strong CYP3A4 inhibitors or inducers — confirm specific medications with trial site).
• People who have had another cancer within the past 5 years, with some exceptions such as certain early-stage or non-invasive cancers that have been surgically treated (confirm with trial site).

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