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PARP Inhibitor
Olaparib for Mesothelioma
Phase 2
Recruiting
Led By Hedy L Kindler, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have a medical diagnosis of malignant mesothelioma confirmed by a physician
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years.
Awards & highlights
Study Summary
This trial will test the effects of olaparib on mesothelioma patients with specific DNA changes.
Who is the study for?
This trial is for mesothelioma patients with specific DNA changes, who've had platinum-based chemo. They must be able to perform daily activities (ECOG 0-1), not have other active cancers, and agree to genetic testing. Women can't be pregnant, and men must use condoms during the study.Check my eligibility
What is being tested?
Researchers are testing Olaparib on mesothelioma patients with gene mutations that affect DNA repair. The goal is to see if it shrinks or stabilizes tumors. Patients will take this drug orally as part of their treatment regimen.See study design
What are the potential side effects?
Olaparib may cause side effects like nausea, fatigue, blood cell count issues which could lead to infections or anemia, digestive problems, shortness of breath, headache and muscle aches. Some people might experience more serious conditions affecting their organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My doctor confirmed I have malignant mesothelioma.
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I am fully active or can carry out light work.
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I am not pregnant.
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My condition improves with platinum-based treatments.
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I have been treated with cisplatin or carboplatin before.
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My organs and bone marrow are functioning normally.
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%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Neuropathy peripheral
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Pruritus
9%
Hyperglycaemia
9%
Aspartate aminotransferase increased
9%
Dizziness
9%
Thrombocytopenia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
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%
General physical health deterioration
1%
Bladder papilloma
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%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
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
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
FDA approved
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,721 Total Patients Enrolled
9 Trials studying Mesothelioma
1,200 Patients Enrolled for Mesothelioma
AstraZenecaIndustry Sponsor
4,271 Previous Clinical Trials
288,612,640 Total Patients Enrolled
8 Trials studying Mesothelioma
1,076 Patients Enrolled for Mesothelioma
Hedy L Kindler, MDPrincipal InvestigatorUniversity of Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor confirmed I have malignant mesothelioma.I still have side effects from past cancer treatments.I have spinal cord compression.I have been diagnosed with MDS or acute myeloid leukemia.My cancer has spread to my brain.I cannot swallow pills or have stomach issues affecting medication absorption.I had cancer before, but I've been free of it for over 3 years.I have had a bone marrow or double cord blood transplant.I am fully active or can carry out light work.I have not had major surgery in the last 2 weeks.I am willing to undergo genetic testing for the study.I do not have any illnesses that can't be controlled.I am willing to follow all study procedures and requirements.My condition does not improve with platinum-based chemotherapy.I haven't had chemotherapy or radiotherapy in the last 3 weeks.You are allergic to olaparib or any of the ingredients in the medication.I have serious health issues or infections that make my medical condition risky.My eligibility will be confirmed through DNA testing at a certified lab.I am not pregnant.I am either male or female.My condition improves with platinum-based treatments.In some rare cases, the doctor will decide if there is conflicting information about how a protein works.I am a male and will use a condom during treatment and for 3 months after.I have been treated with cisplatin or carboplatin before.I have heart conditions that are not under control.I have a weakened immune system or active hepatitis.I have been treated with a PARP inhibitor before.I am not taking any strong or moderate drugs that affect liver enzymes.My organs and bone marrow are functioning normally.Your tumor needs to be a certain size and shape for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
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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