Olaparib in Patients With HRD Malignant Mesothelioma
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|ClinicalTrials.gov Identifier: NCT04515836|
Recruitment Status : Not yet recruiting
First Posted : August 17, 2020
Last Update Posted : January 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Mesothelioma Homologous Recombination Deficiency||Drug: Olaparib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Olaparib in Homologous Recombination Deficient (HRD) Malignant Mesothelioma|
|Estimated Study Start Date :||April 2021|
|Estimated Primary Completion Date :||October 15, 2024|
|Estimated Study Completion Date :||October 15, 2025|
Experimental: Treatment Arm
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.
Olaparib is a chemotherapy drug (packaged as a pill) that can be taken by mouth, twice daily.
Other Name: Lynparza
- 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.
- Overall Survival of Patients Taking Olaparib [ Time Frame: Three years. ]To determine the length of time patients on the study are still alive after taking olaparib.
- Progression-Free Survival of Patients Taking Olaparib [ Time Frame: Two years. ]To determine the length of time patients taking olaparib can live with mesothelioma without their cancer getting worse.
- Frequency of Treatment-Related Side Effects/ Adverse Events [ Time Frame: Two years. ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04515836
|Contact: Hedy L Kindler, MDfirstname.lastname@example.org|
|United States, Illinois|
|University of Chicago Medical Center|
|Chicago, Illinois, United States, 60615|
|Principal Investigator:||Hedy L Kindler, MD||University of Chicago|