BridgeMD
New treatment option for Mesothelioma
Official title Olaparib in Patients With HRD Malignant Mesothelioma
ClinicalTrials.gov ID: NCT04515836
What this study is testing
What is Olaparib?
Olaparib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for mesothelioma.
Also referred to as Lynparza.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Patients with BAP1 tumor predisposition syndrome will be included in the trial. These patients may be eligible if they have a history of...
- Patients with cancer that does not respond to platinum chemotherapy drugs (known as platinum-resistant disease), defined as disease progression...
- Resting electrocardiogram (ECG) that shows the patient has uncontrolled, potentially reversible cardiac conditions or patients with congenital long...
See the full eligibility criteria
Who can 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.