Actively Recruiting
Olaparib in Patients With HRD Malignant Mesothelioma
Led by University of Chicago · Updated on 2025-05-06
56
Participants Needed
1
Research Sites
373 weeks
Total Duration
On this page
Sponsors
U
University of Chicago
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this study, researchers will give olaparib (a drug) to mesothelioma patients who have specific changes in their DNA (known as gene mutations). Researchers will give this drug to each patient on the study to find out if it will help the patient's tumor shrink or stop growing.
CONDITIONS
Official Title
Olaparib in Patients With HRD Malignant Mesothelioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have a medical diagnosis of malignant mesothelioma confirmed by a physician.
- Ability to sign a consent form and agree to study requirements.
- Willingness to provide consent before study procedures and sample collection.
- Willingness to undergo genetic testing of tumor and normal cells.
- Must be 18 years or older.
- Evidence of specific DNA changes such as BAP1 loss or mutations disrupting protein function.
- Prior treatment with cisplatin or carboplatin chemotherapy.
- Platinum-sensitive disease with no progression during or for at least 3 months after platinum chemotherapy.
- Normal organ and bone marrow function within 28 days before study treatment.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 16 weeks.
- Measurable tumor lesion not previously treated with radiation, meeting size criteria by CT scan.
- Both males and females eligible.
- Women of childbearing potential must have a negative pregnancy test within 28 days before treatment.
- Postmenopausal women must show evidence of postmenopausal status.
- Male patients must use condoms during treatment and for 3 months after when having sex with women who are pregnant or of childbearing potential; female partners should use effective contraception.
You will not qualify if you...
- Any uncontrolled illness deemed unsuitable for participation.
- Other cancers unless treated with no evidence for 3 or more years, except certain skin and in situ cancers.
- Platinum-resistant disease with progression during or within 3 months after chemotherapy.
- Uncontrolled cardiac conditions or congenital long QT syndrome.
- Persistent toxicities above grade 2 from previous cancer therapy (except hair loss).
- Myelodysplastic syndrome or acute myeloid leukemia, or suggestive findings.
- Symptomatic brain metastases; stable corticosteroid use allowed if started 4 weeks prior.
- Spinal cord compression without definitive treatment and stable disease for 28 days.
- Poor medical risk from serious uncontrolled disorders or infections.
- Inability to swallow oral medication or gastrointestinal absorption issues.
- Compromised immune system, including HIV positive.
- Active hepatitis B or C infection; past resolved hepatitis B is allowed.
- Prior treatment with any PARP inhibitor including olaparib.
- Chemotherapy or radiotherapy within 3 weeks before study treatment (except for symptom relief).
- Use of strong or moderate CYP3A inhibitors or inducers within specified washout periods.
- Major surgery within 2 weeks before treatment without full recovery.
- Previous allogenic bone marrow or double umbilical cord blood transplant.
- Participation in another clinical trial with study drug within 1 month before this study.
- Known allergy to olaparib or its ingredients.
- Involvement in planning or conduct of the study.
- Unlikely to follow study procedures as judged by the lead physician.
- Pregnant or breastfeeding women.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Chicago Medical Center
Chicago, Illinois, United States, 60615
Actively Recruiting
Research Team
H
Hedy L Kindler, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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