Olaparib in Patients With HRD Malignant Mesothelioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Olaparib
DrugOlaparib is a chemotherapy drug (packaged as a pill) that can be taken by mouth, twice daily.
Treatment groups
56 Participants
are divided into 1 treatment groupGroup A: Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Two years.Secondary outcomes
1
Overall Survival of Patients Taking Olaparib
To determine the length of time patients on the study are still alive after taking olaparib.
Time frame
Three years.2
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.
Time frame
Two years.3
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).
Time frame
Two years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Chicago
Lead sponsor
AstraZeneca
Collaborator
Source ClinicalTrials.gov