Phase 2 Mesothelioma 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 who have been formally diagnosed with malignant mesothelioma by a doctor.
• People who are willing to sign a consent form of their own free will and agree to follow the study's requirements before any study procedures begin.
• People who are willing to undergo genetic testing of both their tumor cells and normal body cells to determine whether they meet the study's eligibility requirements.
• People who agree to have their samples collected for genetic and biomarker research before the treatment phase begins.
• People aged 18 or older.
• People whose cancer shows specific genetic changes — either the loss of a protein called BAP1 (confirmed by testing at the University of Chicago), or a mutation in reproductive or non-reproductive cells that disrupts the function of at least one gene.
• People who have previously been treated with the chemotherapy drugs cisplatin or carboplatin.
• People whose cancer responded to platinum-based chemotherapy, meaning the cancer did not progress during treatment or for at least 3 months after completing it.
• People whose bone marrow and organ function fall within normal ranges, as measured by lab tests taken within 28 days before starting study treatment.
• People with a physical functioning score of 0 or 1 on the ECOG scale, which means they are either fully active or have only minor limitations in physically strenuous activity (confirm with trial site).
• People with a life expectancy of 16 weeks or more.
• People who have at least one measurable area of cancer that has not previously been treated with radiation, meeting specific size requirements as assessed by CT scan.
• Both male and female people are eligible.
• Women of childbearing potential who can provide a negative pregnancy test result within 28 days before starting treatment, confirmed again before the first day of treatment.
• Women who are postmenopausal and can provide evidence of postmenopausal status through one of several accepted methods, including at least one year without a menstrual period following the end of hormonal treatment, hormone levels confirmed in the post-menopausal range by medical tests, removal of the ovaries with no period for more than one year, chemotherapy-related menopause with no period for more than one year, or surgical sterilisation such as removal of both ovaries or the uterus.
• Male participants who are willing to use a condom during treatment and for 3 months after the last dose of the study drug when having sex with a pregnant woman or a woman who could become pregnant. Female partners of male participants who could become pregnant should also use a highly effective form of contraception.

Who may not be able to join:

• People with serious uncontrolled illnesses that the lead study doctor considers unsuitable for trial participation.
• People who have had another type of cancer, unless it was treated and has shown no signs of returning for 3 or more years — with certain exceptions for specific low-risk cancer types including some skin cancers, early-stage cervical cancer, ductal carcinoma in situ (DCIS), and Stage 1, grade 1 endometrial cancer (confirm with trial site).
• People whose cancer did not respond to platinum-based chemotherapy, meaning the cancer progressed during treatment or within 3 months of completing it.
• People whose resting heart trace (ECG) shows uncontrolled or potentially reversible heart conditions, or people with a condition called congenital long QT syndrome.
• People who still have significant side effects from previous cancer treatment (above a certain severity level), other than hair loss.
• People with certain blood or bone marrow disorders, including myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML), or results that suggest these conditions may be present.
• People whose cancer has spread to the brain and who are showing symptoms of serious illness as a result (a brain scan is not required to confirm this; stable use of certain steroids started at least 4 weeks before treatment may be permitted — confirm with trial site).
• People with spinal cord compression, unless they have received a definitive treatment for it and their condition has been clinically stable for at least 28 days.
• People considered to be at high medical risk due to serious uncontrolled medical conditions, non-cancerous systemic disease, or active uncontrolled infection — for example, uncontrolled heart rhythm problems, a heart attack within the past 3 months, uncontrolled seizure disorder, or certain lung or psychiatric conditions.
• People who are unable to swallow tablets or capsules, or who have digestive conditions that are likely to affect how the study drug is absorbed by the body.
• People with a weakened immune system, including those who have tested positive for HIV.
• People with active Hepatitis B or C confirmed by medical testing. People with a past resolved Hepatitis B infection may be eligible. People who have tested positive for Hepatitis C may be eligible only if a further DNA test shows the virus is no longer active.
• People who have previously been treated with a type of drug called a PARP inhibitor, including the study drug olaparib.
• People who have received systemic chemotherapy or radiotherapy (other than for palliative purposes) within 3 weeks before starting the study treatment.
• People currently taking certain medications known as strong or moderate CYP3A inhibitors or inducers (a range of specific drugs that can interfere with how the study drug works in the body), unless those medications have been out of the person's system for the required period before starting the study drug (confirm specific washout periods with the trial site).
• People who have had major surgery within 2 weeks before starting study treatment, or who have not yet fully recovered from a major surgery.
• People who have previously had an allogeneic bone marrow transplant or a double umbilical cord blood transplant.
• People who have taken part in another clinical trial and received a study drug within the month before starting this study.
• People with a known allergy or sensitivity to olaparib or any of its ingredients.
• People who are involved in the planning or running of this trial.
• People who the lead study doctor believes are unlikely to follow the study procedures and requirements.
• Women who are pregnant or breastfeeding.

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