MesotheliomaPhase 2NCT03531840
Olaparib in People With Malignant Mesothelioma
A Phase 2 study testing Olaparib and ClinOmics in people with Mesothelioma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: The drug olaparib may stop cancer cells from fixing damage to their deoxyribonucleic acid (DNA). It has been approved to treat certain cancers in people that were born with a mutation in the breast cancer (BRCA) gene. It has not been approved for treating mesothelioma. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Mesothelioma
- What is being tested?
- Olaparib and ClinOmics
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2018to 21 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically malignant mesothelioma confirmed by the National Cancer Institute (NCI) Laboratory of Pathology. Patients with pleural, peritoneal, pericardial or tunica vaginalis mesothelioma are eligible.
- Archival tumor samples must be available and sufficient for diagnostic and genetic testing; if archival sample insufficient for testing, subject must have lesions amenable to biopsy and be willing to undergo biopsy.
- Patients must have measurable disease.
- Patients must have progressive disease at study entry
- Patients must have received prior platinum and pemetrexed based therapies. Response to platinum is not an eligibility criterion for enrollment.
- Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of olaparib in patients <18 years of age, children are excluded from this study, but may be eligible for future pediatric trials.
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- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1.
- Patients must have a life expectancy of greater than or equal to 16 weeks
- Patients must have adequate organ and marrow function less than or equal to 5 days prior to Cycle 1 Day 1 (C1D1) as defined below:
- leukocytes greater than or equal to 3,000/mcL
- absolute neutrophil count greater than or equal to greater than or equal to 1,500/mcL without growth factor support
- platelets greater than or equal to 100,000/mcL
- hemoglobin greater than or equal to 10 g/dL with no blood transfusion in the past 28 days
- total bilirubin less than or equal to 1.5 x upper limits of normal (ULN) (unless Gilbert's Disease)
- Aspartate aminotransferase (AST) Serum glutamic oxaloacetic transaminase (SGOT)/Alanine aminotransferase (ALT) Serum glutamic-pyruvic transaminase (SGPT) less than or equal to 2.5 X institutional upper limit of normal (less than or equal to 5 X ULN in the presence of liver metastases)
- creatinine clearance greater than or equal to 51 mL/min (calculated using the -Cockcroft-Gault formula.
- Pre-clinical data indicate that olaparib can have adverse effects on embryofetal survival and development. It is further not known whether olaparib or its metabolites are found in seminal fluid. For these reasons:
- Women of childbearing potential and their partners, who are sexually active, must agree to the use of 2 highly effective forms of contraception in combination (male condom plus one other method or must totally/truly abstain from any form of sexual intercourse. This should be started from the signing of the informed consent, throughout their participation in the study and for at least 1 month after the last dose of olaparib.
- Male patients must use a condom during treatment and for 3 months after the last dose of 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. Male patients should not donate sperm throughout the period of taking olaparib and for 3 months following the last dose of olaparib.
- Acceptable birth control methods:
- Total sexual abstinence i.e., refrain from any form of sexual intercourse in line with the patients usual and/or preferred lifestyle. Abstinence must be for the total duration of the study treatment and for at least 1 month (for female patients) or 3 months (for male patients) after the last dose of study treatment. Periodic abstinence (e.g., calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Vasectomised sexual partner PLUS male condom. With participant assurance that partner received post-vasectomy confirmation of azoospermia.
- Tubal occlusion PLUS male condom
- Intrauterine Device PLUS male condom. Provided coils are copper-banded.
- Etonogestrel implants (e.g., Implanon, Norplant) PLUS male condom
- Normal and low dose combined oral pills PLUS male condom
- Hormonal shot or injection (e.g., Depo-Provera) PLUS male condom
- Intrauterine system device (e.g., levonorgestrel-releasing intrauterine system -Mirena) PLUS male condom
- Norelgestromin/ethinyl estradiol transdermal system PLUS male condom
- Intravaginal device (e.g., ethinyl estradiol and etonogestrel) PLUS male condom
- Cerazette (desogestrel) PLUS male condom. Cerazette is currently the only highly efficacious progesterone based pill.
- Ability of subject to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who are receiving any other investigational agents.
- Patients who have received any previous treatment with a Poly (ADP-ribose) polymerase (PARP) inhibitor, including olaparib.
- Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
- Patients with other malignancy documented as occurring within the last 1 year except: adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) documented as curatively treated or under control for greater than or equal to 1 year.
- Patients with features suggestive of Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) on peripheral blood smear.
- Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases 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.
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- History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to olaparib or its excipients.
- Patients who have had a whole blood transfusion within 120 days prior to enrollment. (Packed red blood cells and platelet transfusions are acceptable)
- Patients with persistent toxicities (greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 2) with the exception of alopecia,caused by previous cancer therapy
- Concomitant use of known strong or moderate cytochrome P450, family 3 (CYP3A) inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
- Concomitant use of known strong CYP3A inducers (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
- Resting electrocardiogram (ECG) with Fridericia's formula (QTcF) > 470 msec on 2 or more time points within a 24-hour period or family history of long Q wave, T wave (QT) syndrome
- Patients that have had major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant 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.
- Pregnant women are excluded from this study because olaparib has the potential for teratogenic or abortifacient effects. Women must either be post-menopausal or must have a negative pregnancy test (urine or serum) less than or equal to 28 days prior to enrollment and confirmed on day 1 of cycle 1 of study therapy. Postmenopausal is defined as:
- Amenorrheic for 1 year or more following cessation of exogenous hormonaltreatments
- Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50 years of age
- radiation-induced oophorectomy with last menses >1 year ago
- chemotherapy-induced menopause with >1-year interval since last menses
- surgical sterilisation (bilateral oophorectomy or hysterectomy)
- Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with olaparib, breastfeeding should be discontinued if the mother is treated with olaparib.
- Immunocompromised patients are excluded.
- Patients who are known to be serologically positive for human immunodeficiency virus (HIV). This includes HIV patients on antiretroviral therapy due to the potential for pharmacokinetic interactions with olaparib.
- Patients with known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids
- Previous allogeneic hematopoietic stem cell transplant, allogeneic bone marrow transplant or double umbilical cord blood transplant (duCBT)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Phase II Study of Olaparib in Subjects With Malignant Mesothelioma
Background:
The drug olaparib may stop cancer cells from fixing damage to their deoxyribonucleic acid (DNA). It has been approved to treat certain cancers in people that were born with a mutation in the breast cancer (BRCA) gene. It has not been approved for treating mesothelioma. But some people with mesothelioma have mutations in a gene, BRCA1 Associated Protein 1 (BAP1) related to BRCA. Researchers want to see if olaparib can work in patients with mutations in this gene. They also want to see if works on mutations in other genes or patients without any mutations. They want to see if olaparib causes mesothelioma tumors to shrink.
Read more
Objective:
To study the effect of olaparib on mesothelioma.
Eligibility:
People ages 18 and older with malignant mesothelioma that has already been treated
Design:
Participants will be screened with
Sample of tumor tissue or fluid
Medical history
Physical exam
Blood, heart, and urine tests
Scans and x-rays
Participants will give blood and tissue samples. These will be genetically tested.
The study will be done in 21-day cycles.
Participants will take tables of the study drug 2 times each day. They will get information on what food and drugs to avoid during the study. They will get information about birth control. They will keep a diary of doses and symptoms.
Participants will have blood and urine tests and scans every few weeks.
Participants will be told any important genetic testing results.
Participants will stay in the study until their disease gets worse or the participant or their doctor chooses to stop it.
About 30 days after stopping the study drug, participants will have a follow-up visit. They will have a medical history, physical exam, blood tests, and scans.
Some participants will continue to have scans every 6 weeks.
...
Read the detailed description
Background:
- Malignant mesothelioma is an invasive and often fatal neoplasm that arises from mesothelium that lines several organs.
- Recent studies have identified germline mutations in the gene encoding breast cancer type 1 (BRCA1) associated protein-1 (BAP1) which can predispose to mesothelioma
- In addition to mesothelioma, germline BAP1 mutations confer increased susceptibility for the development of several other tumors including uveal melanoma, cutaneous melanoma, renal cell cancers and possibly other cancers
- In addition to BAP1, we found several novel germline variants that have previously not been associated with risk of developing mesothelioma.
- As evidenced by recent data derived from ovarian and prostate cancer patients, mutations in deoxyribonucleic acid (DNA) repair genes can define subgroups of cancer patients with distinct vulnerabilities to DNA damage response inhibitors.
- Olaparib is a Poly (ADP-ribose) polymerase (PARP) inhibitor indicated as monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated
- Both established and patient derived mesothelioma cell lines with mutated DNA repair genes are sensitive to olaparib.
Objective:
-Determine the efficacy with respect to objective response rate of olaparib in patients with malignant mesothelioma based on somatic or germline mutation status of DNA repair genes
Eligibility:
- Patients must have progressive, histologically or cytologically confirmed malignant mesothelioma.
- Age greater than or equal to 18 years
- Patients must have received prior platinum and pemetrexed based therapies
- Adequate organ and bone marrow function
Design:
- This is a phase II, single center study of olaparib in subjects with malignant mesothelioma
- All subjects will take olaparib by mouth twice daily until disease progression or intolerable side effects
- Subjects will be assessed for safety (continuously) and efficacy (every 6 weeks)
- Subjects will be analyzed in 3 separate comparison groups according to their mutation status
- Comparison Group 1: Patients with a germline mutation in DNA repair genes
- Comparison Group 2: Patients with BAP1 somatic mutations
- Comparison Group 3: Patients with neither germline mutations nor BAP 1 somatic mutations
- Up to 30 evaluable subjects will be enrolled
- Conditions
- Mesothelioma
- Being tested
- Olaparib, ClinOmics
- Keywords
- DNA Mismatch Repair, BAP1, BRCA
- Medical subject headings
- Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaparibDrug
Also called Lynparza
All subjects will take olaparib by mouth twice per day until disease progression or unacceptable toxicity
ClinOmicsDevice
Non-significant risk (NSR) device
| Study group | Role | What they receive |
|---|---|---|
| Arm 1/Olaparib | Experimental | Twice daily oral olaparib Receives: Drug: Olaparib; Device: ClinOmics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Objective Response
Number of participants overall who experienced partial or complete response. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.
Measured: 6 months after enrollment of last patient
Number of Participants With Germline Deoxyribonucleic Acid (DNA) Repair Mutation Who Experienced Partial or Complete Response.
Number of participants with germline deoxyribonucleic acid (DNA) repair mutation who experienced partial or complete response. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.
Measured: 6 months after enrollment of last patient
Percentage of Participants With Breast Cancer Type 1 Associated Protein-1 (BAP1) Somatic Mutations Who Experienced Partial or Complete Response.
Percentage of participants with germline deoxyribonucleic acid (DNA) repair mutation who experienced partial or complete response. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.
Measured: 6 months after enrollment of last patient
Percentage of Subjects With Neither Germline Deoxyribonuclecic Acid (DNA) Repair Mutations Nor Somatic Breast Cancer Type 1 Associated Protein-1 (BAP1) Mutations Who Experienced Partial or Complete Response.
Percentage of subjects with neither germline DNA repair mutations nor somatic BAP1 mutations who experienced partial or complete response.Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.
Measured: 6 months after enrollment of last patient
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Measured: Adverse events were recorded from the study start date until prior to the study completion date, approximately 27 months and 11 days.
Secondary outcomes (1)
Number of Participants With Dose Limiting-toxicities (DLT's)
Dose Limiting-toxicities (DLT's) is defined as
Measured: 21 days after enrollment of last subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start11 Jul 2018
- Primary completion4 Dec 2019
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Raffit Hassan, M.D., National Cancer Institute (NCI)
- Investigators
- Raffit Hassan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531840
- Sponsor's protocol ID
- 180097
- Other IDs
- 18-C-0097
- Status last verified
- Mar 2021
- First submitted
- 18 May 2018
- Last updated
- 9 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Olaparib in Subjects With Malignant Mesothelioma
- ClinicalTrials.gov ID
- NCT03531840
- Acronym / sponsor ID
- 180097
- Conditions
- Mesothelioma
- Keywords
- DNA Mismatch Repair, BAP1, BRCA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Posted 11 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
The drug olaparib may stop cancer cells from fixing damage to their deoxyribonucleic acid (DNA). It has been approved to treat certain cancers in people that were born with a mutation in the breast cancer (BRCA) gene. It has not been approved for treating mesothelioma. But some people with mesothelioma have mutations in a gene, BRCA1 Associated Protein 1 (BAP1) related to BRCA. Researchers want to see if olaparib can work in patients with mutations in this gene. They also want to see if works on mutations in other genes or patients without any mutations. They want to see if olaparib causes mesothelioma tumors to shrink.
Objective:
To study the effect of olaparib on mesothelioma.
Eligibility:
People ages 18 and older with malignant mesothelioma that has already been treated
Design:
Participants will be screened with
Sample of tumor tissue or fluid
Medical history
Physical exam
Blood, heart, and urine tests
Scans and x-rays
Participants will give blood and tissue samples. These will be genetically tested.
The study will be done in 21-day cycles.
Participants will take tables of the study drug 2 times each day. They will get information on what food and drugs to avoid during the study. They will get information about birth control. They will keep a diary of doses and symptoms.
Participants will have blood and urine tests and scans every few weeks.
Participants will be told any important genetic testing results.
Participants will stay in the study until their disease gets worse or the participant or their doctor chooses to stop it.
About 30 days after stopping the study drug, participants will have a follow-up visit. They will have a medical history, physical exam, blood tests, and scans.
Some participants will continue to have scans every 6 weeks.
...
Detailed description
Background:
- Malignant mesothelioma is an invasive and often fatal neoplasm that arises from mesothelium that lines several organs.
- Recent studies have identified germline mutations in the gene encoding breast cancer type 1 (BRCA1) associated protein-1 (BAP1) which can predispose to mesothelioma
- In addition to mesothelioma, germline BAP1 mutations confer increased susceptibility for the development of several other tumors including uveal melanoma, cutaneous melanoma, renal cell cancers and possibly other cancers
- In addition to BAP1, we found several novel germline variants that have previously not been associated with risk of developing mesothelioma.
- As evidenced by recent data derived from ovarian and prostate cancer patients, mutations in deoxyribonucleic acid (DNA) repair genes can define subgroups of cancer patients with distinct vulnerabilities to DNA damage response inhibitors.
- Olaparib is a Poly (ADP-ribose) polymerase (PARP) inhibitor indicated as monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated
- Both established and patient derived mesothelioma cell lines with mutated DNA repair genes are sensitive to olaparib.
Objective:
-Determine the efficacy with respect to objective response rate of olaparib in patients with malignant mesothelioma based on somatic or germline mutation status of DNA repair genes
Eligibility:
- Patients must have progressive, histologically or cytologically confirmed malignant mesothelioma.
- Age greater than or equal to 18 years
- Patients must have received prior platinum and pemetrexed based therapies
- Adequate organ and bone marrow function
Design:
- This is a phase II, single center study of olaparib in subjects with malignant mesothelioma
- All subjects will take olaparib by mouth twice daily until disease progression or intolerable side effects
- Subjects will be assessed for safety (continuously) and efficacy (every 6 weeks)
- Subjects will be analyzed in 3 separate comparison groups according to their mutation status
- Comparison Group 1: Patients with a germline mutation in DNA repair genes
- Comparison Group 2: Patients with BAP1 somatic mutations
- Comparison Group 3: Patients with neither germline mutations nor BAP 1 somatic mutations
- Up to 30 evaluable subjects will be enrolled
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1/Olaparib | Experimental | Drug: Olaparib, Device: ClinOmicsTwice daily oral olaparib |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Patients must have histologically or cytologically malignant mesothelioma confirmed by the National Cancer Institute (NCI) Laboratory of Pathology. Patients with pleural, peritoneal, pericardial or tunica vaginalis mesothelioma are eligible.
- Archival tumor samples must be available and sufficient for diagnostic and genetic testing; if archival sample insufficient for testing, subject must have lesions amenable to biopsy and be willing to undergo biopsy.
- Patients must have measurable disease.
- Patients must have progressive disease at study entry
- Patients must have received prior platinum and pemetrexed based therapies. Response to platinum is not an eligibility criterion for enrollment.
Key exclusion criteria (26 listed)
- Patients who are receiving any other investigational agents.
- Patients who have received any previous treatment with a Poly (ADP-ribose) polymerase (PARP) inhibitor, including olaparib.
- Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
- Patients with other malignancy documented as occurring within the last 1 year except: adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) documented as curatively treated or under control for greater than or equal to 1 year.
- Patients with features suggestive of Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) on peripheral blood smear.
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: LynparzaAll subjects will take olaparib by mouth twice per day until disease progression or unacceptable toxicity | Drug | Arm 1/Olaparib |
| ClinOmicsNon-significant risk (NSR) device | Device | Arm 1/Olaparib |
Primary outcome
Number of Participants With an Objective Response
Time frame: 6 months after enrollment of last patient
Number of participants overall who experienced partial or complete response. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.
Number of Participants With Germline Deoxyribonucleic Acid (DNA) Repair Mutation Who Experienced Partial or Complete Response.
Time frame: 6 months after enrollment of last patient
Number of participants with germline deoxyribonucleic acid (DNA) repair mutation who experienced partial or complete response. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.
Percentage of Participants With Breast Cancer Type 1 Associated Protein-1 (BAP1) Somatic Mutations Who Experienced Partial or Complete Response.
Time frame: 6 months after enrollment of last patient
Percentage of participants with germline deoxyribonucleic acid (DNA) repair mutation who experienced partial or complete response. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.
Percentage of Subjects With Neither Germline Deoxyribonuclecic Acid (DNA) Repair Mutations Nor Somatic Breast Cancer Type 1 Associated Protein-1 (BAP1) Mutations Who Experienced Partial or Complete Response.
Time frame: 6 months after enrollment of last patient
Percentage of subjects with neither germline DNA repair mutations nor somatic BAP1 mutations who experienced partial or complete response.Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Time frame: Adverse events were recorded from the study start date until prior to the study completion date, approximately 27 months and 11 days.
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
1 secondary outcome
Number of Participants With Dose Limiting-toxicities (DLT's)
Time frame: 21 days after enrollment of last subject
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
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. This study is not recruiting at the moment.
Raffit Hassan, M.D. principal investigator
National Cancer Institute (NCI)
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 and ClinOmics in people with Mesothelioma, run by National Cancer Institute (NCI) 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 32 inclusion and 26 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: finished, as of the sponsor's last update on 9 Apr 2021. 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?
Yes. Results are posted in the registry (first posted 11 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With an Objective Response (time frame: 6 months after enrollment of last patient). The study lists 5 primary outcomes in all. 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 9 Apr 2021.