CLINICAL TRIAL

Olaparib for Mesothelioma

Recruiting · 18+ · All Sexes · Chicago, IL

This study is evaluating whether a drug may help patients with mesothelioma.

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About the trial for Mesothelioma

Eligible Conditions
Mesothelioma, Malignant · Mesothelioma · Homologous Recombination Deficiency (HRD)

Treatment Groups

This trial involves 2 different treatments. Olaparib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Olaparib
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved

Side Effect Profile for HRRm^

HRRm^
Show all side effects
Nausea
59%
Fatigue
47%
Anaemia
34%
Vomiting
31%
Abdominal pain
25%
Diarrhoea
22%
Headache
19%
Dyspnoea
19%
Cough
19%
Dyspepsia
16%
Decreased appetite
16%
Constipation
13%
Urinary tract infection
13%
Dysgeusia
13%
Dizziness
13%
Abdominal pain lower
9%
Abdominal distension
9%
Blood creatinine increased
9%
Pain in extremity
9%
Back pain
9%
Rash
9%
Myalgia
6%
Deep vein thrombosis
6%
Pyrexia
6%
Gastrooesophageal reflux disease
6%
Nasopharyngitis
6%
Asthenia
6%
Oral candidiasis
6%
Respiratory tract infection
6%
Hypomagnesaemia
6%
Muscle spasms
6%
Alopecia
6%
Oropharyngeal pain
6%
Thrombocytopenia
3%
Mucosal inflammation
3%
Vertigo
3%
Myocardial infarction
3%
Gastroenteritis viral
3%
Femoral neck fracture
3%
Pleural effusion
3%
Pulmonary embolism
3%
Neutropenia
3%
Oedema peripheral
3%
Upper respiratory tract infection
3%
Alanine aminotransferase increased
3%
Neutrophil count decreased
3%
Platelet count decreased
3%
White blood cell count decreased
3%
Depression
3%
Insomnia
3%
Pruritus
3%
Personality change
0%
Foot fracture
0%
Anxiety
0%
Abdominal hernia
0%
Angina unstable
0%
Atrial fibrillation
0%
Mesenteric vein thrombosis
0%
Small intestinal obstruction
0%
Sudden death
0%
Colonic abscess
0%
Contrast media allergy
0%
Lower respiratory tract infection
0%
Sepsis
0%
Procedural pain
0%
Burkitt's lymphoma
0%
Papillary thyroid cancer
0%
Acute myeloid leukaemia
0%
Dysarthria
0%
Transient ischaemic attack
0%
Leukopenia
0%
Abdominal pain upper
0%
Influenza
0%
Influenza like illness
0%
Peripheral swelling
0%
Glomerular filtration rate decreased
0%
Arthralgia
0%
Musculoskeletal pain
0%
Taste disorder
0%
Irritability
0%
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT02476968) in the HRRm^ ARM group. Side effects include: Nausea with 59%, Fatigue with 47%, Anaemia with 34%, Vomiting with 31%, Abdominal pain with 25%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Must have a medical diagnosis of malignant mesothelioma that has been confirmed by a physician.
Must be willing to sign and date consent form before any mandatory study-specific procedures, sample collecting and tests.
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.
Willing to experience genetic testing to determine study eligibility. Must be willing to genetically test tumor and normal body cells.
Before participating in the treatment phase of this study, participants must be willing to give their own consent (agreement) to have their samples collected for genetic and biomarker research.
Age 18 or older.
Patients must have platinum-sensitive disease (cancer that responds to treatments with anticancer drugs containing metal platinum). For eligibility in this study, platinum-sensitive disease will be defined as no disease progression while on a platinum agent (chemotherapy drug) or for at least 3 months after completing treatment with a platinum agent.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Three years.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Three years..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Olaparib will improve 1 primary outcome and 3 secondary outcomes in patients with Mesothelioma. Measurement will happen over the course of Three years..

Overall Survival of Patients Taking Olaparib
THREE YEARS.
To determine the length of time patients on the study are still alive after taking olaparib.
Objective Response Rate of Patients to Olaparib
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.
Frequency of Treatment-Related Side Effects/ Adverse Events
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).
Progression-Free Survival of Patients Taking Olaparib
TWO YEARS.
To determine the length of time patients taking olaparib can live with mesothelioma without their cancer getting worse.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can mesothelioma be cured?

There is a small but constant risk that mesothelioma will disappear and be replaced by another malignancy and the risks should therefore be weighed in the therapeutic choices, especially when the second malignancy is expected to have a dismal prognosis.

Anonymous Patient Answer

What are common treatments for mesothelioma?

Mesothelioma is generally treatable with surgery followed by chemotherapy. Survival rates are dependent on a multitude of factors, including patient age, performance status, and stage at diagnosis. The role of chemotherapy remains controversial. Given the generally poor prognosis for this disease, palliative supportive interventions may be prioritized prior to chemotherapy.

Anonymous Patient Answer

What is mesothelioma?

Mesothelioma is a rare, fatal disease that is often associated with exposure to asbestos. It is the second-most common cause of cancer after breast cancer.\n

Anonymous Patient Answer

What are the signs of mesothelioma?

Symptoms such as ipsilateral abdominal pain, ipsilateral or bilateral pleural effusion, weight loss, and ipsilateral coughing up blood or pleural fluid should be remembered in patients with mesothelioma.

Anonymous Patient Answer

How serious can mesothelioma be?

The seriousness of mesothelioma has been largely underestimated in the medical community, and some doctors and hospitals have been misinformed about the nature of the disease. However, it is important for the patient to be aware of his or her own prognosis. If the disease progresses too much, or metastasizes too widely, a surgical removal of the diseased pleura (lungs) may not be possible or advisable because of the patient's weakened state and may be a last resort option only. In any event, the disease is often fatal by late-stage, because many doctors have admitted that mesothelioma often can't be cured, rather than being cured at all.

Anonymous Patient Answer

What is the latest research for mesothelioma?

A comprehensive review of mesothelioma research was carried out. A series of randomized controlled trials of pemetrexed-based protocols were undertaken at the European Organisation for Research and Treatment of Cancer. Results from a recent paper of these studies were reported. Additional studies were carried out. An update on the latest clinical trials in treatment, biomarker work, and translational research was also reviewed. A series of articles on the epidemiology of pleural mesothelioma were published. The best clinical presentation and staging systems for clinical and staging are discussed. A large series of studies of circulating biomarkers for mesothelioma have been reported.

Anonymous Patient Answer

What does olaparib usually treat?

Olaparib usually treats cancer arising in the lining of the heart; pericardial effusions, usually due to heart disease. However, we are unaware, as yet, whether olaparib treats other kinds of cancer.

Anonymous Patient Answer

Is olaparib safe for people?

Data from a recent study of this trial, combining the clinical and statistical information from the two trials, show that olaparib has a high safety profile, and tolerable toxicity profile, in a large population of people with gBRCAmes+ metastatic breast cancer. Olaparib should also be considered as safe for people with T790M mutations, particularly when given in combination with a tyrosine kinase inhibitor.

Anonymous Patient Answer
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