MesotheliomaPhase 2NCT04515836
Olaparib in Patients With HRD Malignant Mesothelioma
A Phase 2 study testing Olaparib in people with Mesothelioma and Homologous Recombination Deficiency, run by University of Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelioma, Homologous Recombination Deficiency
- What is being tested?
- Olaparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2021to 15 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have a medical diagnosis of malignant mesothelioma that has been confirmed by a physician.
- Participant must be able to sign a consent form stating that they choose (of their own free will) to participate in the study and agree to follow the study requirements and restrictions that are listed in the consent form.
- Must be willing to sign and date consent form before any mandatory study-specific procedures, sample collecting and tests.
- Willing to experience genetic testing to determine study eligibility. Must be willing to genetically test tumor and normal body cells.
- Before participating in the treatment phase of this study, participants must be willing to give their own consent (agreement) to have their samples collected for genetic and biomarker research.
- Age 18 or older.
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- Participant must show evidence of specific DNA changes/genetic mutations defined as follows: A) BAP1 loss (the loss of a protein called ubiquitin carboxyl-terminal hydrolase) verified by physicians at the University of Chicago using sampling tests AND/OR B) A mutation (abnormal change) in the participant's germ cells (reproductive cells) or somatic cells (non-reproductive cells) that disrupts protein function in at least one of the patient's genes.
- Prior treatment with cisplatin or carboplatin is required.
- Patients must have platinum-sensitive disease (cancer that responds to treatments with anticancer drugs containing metal platinum). For eligibility in this study, platinum-sensitive disease will be defined as no disease progression while on a platinum agent (chemotherapy drug) or for at least 3 months after completing treatment with a platinum agent.
- Patients must have normal organ and bone marrow function measured within 28 days prior to receiving study treatment. Normal bone marrow and organ function will be assessed using specific lab tests/ criteria set by the study's lead physician.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patients must have a life expectancy of 16 weeks or more.
- Must have a tumor that can be measured according to criteria set by the modified Response Evaluation Criteria in Solid Tumors (RECIST) standards for pleural mesothelioma and RECIST 1.1 for peritoneal and tunica vaginalis mesothelioma. Patients in the study must have at least one area of damaged tissue (a lesion) that has not received previous radiation treatment. This damaged tissue must be accurately measured at the beginning of the study as greater than or equal to 10 mm in the longest diameter (except lymph nodes which must have short axis greater than or equal to 15 mm). The patient's tumor would be measured using computed tomography (CT), which is suitable for accurate repeated measurements.
- Both male and female patients can participate in this study.
- If a woman is of childbearing potential and wishes to participate in the study, she most show evidence that she is not pregnant using a negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.
- Women who are postmenopausal and wish to participate in the study, must also show evidence of postmenopausal status. Postmenopausal status will be defined as: 1) A woman who does not experience menstruation (known as amenorrhea) for 1 year or more following the end of hormonal treatments. 2) Women who have reproductive/hormone levels in the post-menopausal range for women under 50 as confirmed by medical tests; 3) Radiation-induced oophorectomy (removal of one or more ovaries) with last menses greater than 1 year ago; 4) Menopause caused by chemotherapy with greater than 1 year since last menses 5) Surgical sterilization (bilateral oophorectomy or hysterectomy).
- Male patients must use a condom during treatment and for 3 months after the last dose of study drug (olaparib) when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential.
- NOTE 1: Tests to confirm the eligibility of participants who have the above mutations (altered germ or somatic cells) will take place at a germline or tumor sequencing lab that is certified under the Clinical Laboratory Improvement Amendments (CLIA). Eligibility of study participants will be confirmed once the physical leading this study receives the official mutation report from the lab and confirms that the participant's identified mutation fits the definition outlined above. All other patients must consent to tumor and normal sample sequencing as described in study procedures below during the prescreening phase to determine eligibility.
- NOTE 2: Rare exceptions of participants who may have conflicting evidence regarding protein function will be interpreted on an individual basis by the physician leading the study.
Who cannot join
- Medical conditions:
- Any evidence of uncontrollable illness that the physician leading this study deems undesirable for the patient to participate in the trial.
- Other malignancy (tumor/cancer) unless it has been treated with no evidence of disease for 3 or more years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.
- Patients with BAP1 tumor predisposition syndrome will be included in the trial. These patients may be eligible if they have a history of syndrome-related cancers, provided they completed their surgery and chemotherapy more than three years prior to registration, and the patient remains free of disease that continues to re-occur or spread to other parts of the body.
- Patients with cancer that does not respond to platinum chemotherapy drugs (known as platinum-resistant disease), defined as disease progression during or within 3 months of receiving chemotherapy.
- Resting electrocardiogram (ECG) that shows the patient has uncontrolled, potentially reversible cardiac conditions or patients with congenital long QT syndrome (a heart rhythm condition that can cause fast, chaotic heartbeats), as judged by the study's lead physician.
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- Persistent toxicities (greater than the Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
- Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with findings suggestive of MDS/AML.
- Patients with cancer cells that have moved from one part of their body to the brain (brain metastases) causing the patient to show symptoms/signs of more serious illness. A scan to confirm the absence of cancerous cells in the brain is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment.
- Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-cancerous systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
- Patients unable to swallow oral medications and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- Patients who have a compromised immune system, e.g., patients who have tested positive for human immunodeficiency virus (HIV).
- Patients with known active hepatitis (i.e. Hepatitis B or C) confirmed by medical tests; patients with a past or resolved Hepatitis B infection are eligible. Patients positive for hepatitis C virus are eligible only if samples of the patient's DNA tests negative for hepatitis C, according to genetic tests (using polymerase chain reaction).
- Prior/concomitant therapy (medications/treatments that may conflict with the study drug, olaparib):
- Any previous treatment with a type of drug/substance called a PARP inhibitor (which stands for poly-ADP ribose polymerase inhibitor), including olaparib.
- Receipt of any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment.
- Patients who are using strong cancer drugs called CYP3A inhibitors (also called Cytochrome P-450) for treatment (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). Any treatment previously taken by the patient must be washed out of the patient's system 2 weeks before taking olaparib in this study.
- Patients who are using known strong CYP3A inducers (drugs for cancer patients including phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). Any patients taking enzalutamide must have the drug washed out of their system 5 weeks before stating olaparib in this study; patients taking phenobarbital and other agents must have the drug washed out of their system 3 weeks before taking olaparib in this study.
- Major surgery within 2 weeks of starting study treatment; patients must have recovered from any effects of any major surgery.
- Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
- Prior/concurrent clinical study experience:
- Participation in another clinical study where the patient received a study drug in the last month before starting this study.
- Patients with a known hypersensitivity to olaparib or any of the ingredients in the product.
- Other exclusions:
- Involvement in the planning and/or conduct of the study.
- The lead study physician deciding that the patient should not participate in the study if the patient is unlikely to follow study procedures, restrictions and requirements.
- Pregnant or breast-feeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60615
About this study
Official title: Phase II Trial of Olaparib in Homologous Recombination Deficient (HRD) Malignant Mesothelioma
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
- Mesothelioma, Homologous Recombination Deficiency
- Being tested
- Olaparib
- Keywords
- mesothelioma, lung cancer, malignant mesothelioma
- Medical subject headings
- Mesothelioma, Lung Neoplasms, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaparibDrug
Also called Lynparza
Olaparib is a chemotherapy drug (packaged as a pill) that can be taken by mouth, twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Olaparib will be given orally to patients in 28-day cycles. Patients will attend the clinic on days 1 (first day of treatment) and 15 of the first cycle following the beginning of study treatment and then every 4 weeks (day 1 of every cycle) until discontinuation of treatment. Receives: Drug: Olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate of Patients to Olaparib
To determine the percentage of patients with mesothelioma tumors (containing certain gene/cell mutations) that shrink or stop growing as a response to olaparib.
Measured: Two years.
Secondary outcomes (3)
Overall Survival of Patients Taking Olaparib
To determine the length of time patients on the study are still alive after taking olaparib.
Measured: Three years.
Progression-Free Survival of Patients Taking Olaparib
To determine the length of time patients taking olaparib can live with mesothelioma without their cancer getting worse.
Measured: Two years.
Frequency of Treatment-Related Side Effects/ Adverse Events
To determine the frequency of treatment-related side effects/ adverse events reported among study participants. These side effects will be assessed by attribution (source), type and grade. Adverse events/side effects will be graded using the NCI Common Terminology Criteria for Adverse Events (Version 5).
Measured: Two years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start19 Feb 2021
- Primary completion15 Apr 2028 (estimated)
- Study completion15 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Hedy L Kindler, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515836
- Sponsor's protocol ID
- IRB20-0117
- Status last verified
- May 2025
- First submitted
- 18 Jul 2020
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Olaparib in Homologous Recombination Deficient (HRD) Malignant Mesothelioma
- ClinicalTrials.gov ID
- NCT04515836
- Acronym / sponsor ID
- IRB20-0117
- Conditions
- Mesothelioma, Homologous Recombination Deficiency
- Keywords
- mesothelioma, lung cancer, malignant mesothelioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 15 Apr 2028 (estimated)
- Study completion
- 15 Apr 2028 (estimated)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: OlaparibOlaparib will be given orally to patients in 28-day cycles. Patients will attend the clinic on days 1 (first day of treatment) and 15 of the first cycle following the beginning of study treatment and then every 4 weeks (day 1 of every cycle) until discontinuation of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Must have a medical diagnosis of malignant mesothelioma that has been confirmed by a physician.
- Participant must be able to sign a consent form stating that they choose (of their own free will) to participate in the study and agree to follow the study requirements and restrictions that are listed in the consent form.
- Must be willing to sign and date consent form before any mandatory study-specific procedures, sample collecting and tests.
- Willing to experience genetic testing to determine study eligibility. Must be willing to genetically test tumor and normal body cells.
- Before participating in the treatment phase of this study, participants must be willing to give their own consent (agreement) to have their samples collected for genetic and biomarker research.
Key exclusion criteria (28 listed)
- Any evidence of uncontrollable illness that the physician leading this study deems undesirable for the patient to participate in the trial.
- Other malignancy (tumor/cancer) unless it has been treated with no evidence of disease for 3 or more years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.
- Patients with BAP1 tumor predisposition syndrome will be included in the trial. These patients may be eligible if they have a history of syndrome-related cancers, provided they completed their surgery and chemotherapy more than three years prior to registration, and the patient remains free of disease that continues to re-occur or spread to other parts of the body.
- Patients with cancer that does not respond to platinum chemotherapy drugs (known as platinum-resistant disease), defined as disease progression during or within 3 months of receiving chemotherapy.
- Resting electrocardiogram (ECG) that shows the patient has uncontrolled, potentially reversible cardiac conditions or patients with congenital long QT syndrome (a heart rhythm condition that can cause fast, chaotic heartbeats), as judged by the study's lead physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlaparibAlso: LynparzaOlaparib is a chemotherapy drug (packaged as a pill) that can be taken by mouth, twice daily. | Drug | Treatment Arm |
Primary outcome
Objective Response Rate of Patients to Olaparib
Time frame: Two years.
To determine the percentage of patients with mesothelioma tumors (containing certain gene/cell mutations) that shrink or stop growing as a response to olaparib.
3 secondary outcomes
Overall Survival of Patients Taking Olaparib
Time frame: Three years.
Progression-Free Survival of Patients Taking Olaparib
Time frame: Two years.
Frequency of Treatment-Related Side Effects/ Adverse Events
Time frame: Two years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hedy L Kindler, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olaparib in people with Mesothelioma and Homologous Recombination Deficiency, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hedy L Kindler, MD (773-702-0360, hkindler@medicine.bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate of Patients to Olaparib (time frame: Two years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.