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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 study's lead physician.
Must have a medical diagnosis of malignant mesothelioma that has been confirmed by a physician.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Uptwo years.
Awards & highlights
No Placebo-Only Group
Study Summary
This trial will test the effects of olaparib on mesothelioma patients with specific DNA changes.
Eligible Conditions
- Mesothelioma
- Homologous Recombination Deficiency
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
Your bone marrow and organs must be functioning normally, which will be checked with some medical tests before participating in the study.
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You have been diagnosed by a doctor with malignant mesothelioma.
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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.
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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.
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You must have been treated with cisplatin or carboplatin before.
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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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate of Patients to Olaparib
Secondary outcome measures
Frequency of Treatment-Related Side Effects/ Adverse Events
Overall Survival of Patients Taking Olaparib
Progression-Free Survival of Patients Taking Olaparib
Side effects data
From 2023 Phase 3 trial • 154 Patients • NCT0218419549%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Dyspnoea
11%
Alanine aminotransferase increased
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Neuropathy peripheral
10%
Pruritus
9%
Thrombocytopenia
9%
Dizziness
9%
Hyperglycaemia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
9%
Aspartate aminotransferase increased
8%
Blood creatinine increased
8%
Weight decreased
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Dysgeusia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
General physical health deterioration
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Bladder papilloma
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2017
Completed Phase 4
~1270
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
972 Previous Clinical Trials
795,637 Total Patients Enrolled
9 Trials studying Mesothelioma
1,200 Patients Enrolled for Mesothelioma
AstraZenecaIndustry Sponsor
4,182 Previous Clinical Trials
289,630,321 Total Patients Enrolled
8 Trials studying Mesothelioma
1,342 Patients Enrolled for Mesothelioma
Hedy L Kindler, MDPrincipal InvestigatorUniversity of Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
For what conditions is Olaparib commonly prescribed?
"Olaparib is a possible treatment for advanced directives, malignant neoplasms of the ovary, and primary peritoneal cancer."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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