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Study Summary
This trial will test the effects of olaparib on mesothelioma patients with specific DNA changes.
- Mesothelioma
- Homologous Recombination Deficiency
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 154 Patients • NCT02184195Awards & Highlights
Trial Design
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Who is running the clinical trial?
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- You must be 18 years old or above.You have received a bone marrow transplant from another person in the past.You are willing to take a genetic test to see if you are eligible for the study. This test will check your tumor and normal body cells.You must agree to allow us to collect samples of your genetic and biomarker information for research purposes before starting the treatment phase of this study.You must have been treated with cisplatin or carboplatin before.Your cancer must be responsive to platinum-based chemotherapy. This means that your cancer did not get worse while taking a platinum drug, or you went at least three months without your cancer getting worse after finishing platinum-based chemotherapy.You agree to allow researchers to study your genes and biomarkers.You must have been treated with cisplatin or carboplatin before.You still have side effects from a past cancer treatment, except for hair loss.You have a weakened immune system, such as being HIV positive.Your bone marrow and organs must be functioning normally, which will be checked with some medical tests before participating in the study.You are pregnant or currently breastfeeding.You must agree to sign a consent form before any study-related procedures, samples or tests can be done.You have been diagnosed by a doctor with malignant mesothelioma.You must be willing to sign a form saying that you want to be part of the study and follow all the rules listed in the form.You have specific changes in your DNA that have been confirmed by doctors at the University of Chicago. These changes are related to the loss of a protein called BAP1, or mutations that disrupt the function of at least one of your genes.The doctor thinks you will live for at least another 4 months.You have an illness that is not under control and may affect your ability to participate in the study.Both men and women are eligible to participate.If you are a male participant, you must use a condom during treatment and for 3 months after the last dose of study drug.You cannot have had any other type of cancer within the past 3 years, unless it has been successfully treated and there is no evidence of it anymore.You have spinal cord compression that has not been treated effectively.
- Group 1: Treatment Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Have any other investigations been conducted revolving around Olaparib?
"Presently, Olaparib is the focus of 188 active trials with 27 at Stage 3. Though Houston has a few clinical sites researching this drug, there are over 9250 locations that have registered for these investigations."
Is the research being conducted here unprecedented?
"At present, 188 ongoing trials involving Olaparib have been conducted in 1468 cities and 59 countries. The earliest of these studies was launched by AstraZeneca back in 2005, with 98 participants participating during the Phase 1 approval period. Since then, 63 more clinical research projects have been completed."
How hazardous are the effects of Olaparib on human health?
"Olaparib has been rated 2 on a scale of 1 to 3 due to the limited amount of clinical data affirming its safety, although there is yet no evidence ascertaining its efficacy."
For what conditions is Olaparib commonly prescribed?
"Olaparib is a possible treatment for advanced directives, malignant neoplasms of the ovary, and primary peritoneal cancer."
Are there any openings remaining for those wishing to participate in this trial?
"Affirmative. According to clinicaltrials.gov, this medical experiment is actively enrolling patients. Initially made public on February 19th 2021 and recently modified on May 12th 2021, the trial seeks 56 participants from one centre."
What is the maximum capacity of participants in this clinical experiment?
"Affirmative. According to the information found on clinicaltrials.gov, this medical trial which was originally made available on February 19th 2021 is currently recruiting participants. Approximately 56 individuals will be accepted at a single location for their involvement in this study."
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