Study on Olaparib for Patients with Specific Genetic Changes in Malignant Mesothelioma

Inclusion Criteria

• Must have a confirmed diagnosis of malignant mesothelioma.
• Must be able to sign a consent form to participate and agree to follow study requirements.
• Willing to undergo genetic testing to determine eligibility, including testing of tumor and normal cells.
• Must consent to have samples collected for genetic and biomarker research before treatment.
• Age 18 or older.
• Must have specific DNA changes, such as BAP1 loss or mutations affecting protein function in certain genes.
• Must have had prior treatment with cisplatin or carboplatin.
• Must have cancer that responds to platinum-based chemotherapy.
• Must have normal organ and bone marrow function as per lab tests.
• ECOG performance status of 0-1.
• Life expectancy of 16 weeks or more.
• Must have a measurable tumor according to specific criteria.
• Both male and female patients can participate.
• Women of childbearing potential must show a negative pregnancy test before treatment.
• Postmenopausal women must provide evidence of their status.
• Male patients must use a condom during treatment and for 3 months after the last dose.
• Genetic testing for eligibility will be done in a certified lab.
• Rare exceptions regarding protein function will be considered individually by the study physician.

Exclusion Criteria

• Uncontrollable illness deemed unsuitable for participation.
• Other cancers unless treated and disease-free for 3+ years, except certain skin and cervical cancers.
• Cancer that does not respond to platinum chemotherapy.
• Uncontrolled heart conditions or congenital long QT syndrome.
• Persistent side effects from previous cancer therapy, except hair loss.
• Myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
• Cancer spread to the brain causing symptoms.
• Serious, uncontrolled medical disorders or infections.
• Unable to swallow oral medications or have digestive issues affecting absorption.
• Compromised immune system, e.g., HIV positive.
• Active hepatitis B or C infections.
• Previous treatment with PARP inhibitors.
• Recent chemotherapy or radiotherapy within 3 weeks.
• Use of certain strong or moderate cancer drugs that affect olaparib.
• Major surgery within 2 weeks of starting treatment.
• Previous bone marrow or cord blood transplant.
• Participation in another clinical study recently.
• Known allergy to olaparib or its ingredients.
• Involvement in the study planning or conduct.
• Lead physician decides participation is not suitable.
• Pregnant or breastfeeding women.