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PARP Inhibitor

Olaparib for Mesothelioma

University of Chicago Medical Center, Chicago, IL
Targeting 2 different conditionsOlaparibPhase 2RecruitingLed by Hedy L Kindler, MDResearch Sponsored by University of Chicago

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 below
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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.
Select...
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 weeks
Treatment ~ Varies
Follow Up ~three years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and three years. for reporting.

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 • NCT02184195
49%
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

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04515836 — Phase 2
Mesothelioma Research Study Groups: Treatment Arm
Mesothelioma Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT04515836 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04515836 — Phase 2

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
~13 spots leftby Oct 2024