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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

Must not have

Previous allogenic bone marrow transplant or double umbilical cord blood transplantation

Persistent toxicities caused by previous cancer therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years.

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a bone marrow or double cord blood transplant.

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I still have side effects from past cancer treatments.

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I have spinal cord compression.

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I have been diagnosed with MDS or acute myeloid leukemia.

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My cancer has spread to my brain.

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I cannot swallow pills or have stomach issues affecting medication absorption.

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I have not had major surgery in the last 2 weeks.

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I do not have any illnesses that can't be controlled.

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My condition does not improve with platinum-based chemotherapy.

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I have heart conditions that are not under control.

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I have a weakened immune system or active hepatitis.

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I have been treated with a PARP inhibitor before.

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I am not taking any strong or moderate drugs that affect liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ three years.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate of Patients to Olaparib

Secondary study objectives

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%

Alanine aminotransferase increased

11%

Dyspnoea

10%

Neuropathy peripheral

10%

Cough

10%

Abdominal pain upper

10%

Dyspepsia

10%

Anxiety

10%

Pruritus

Hyperglycaemia

Dizziness

Aspartate aminotransferase increased

Thrombocytopenia

Oedema peripheral

Pain in extremity

Insomnia

Stomatitis

Dry mouth

Headache

Neutropenia

Blood creatinine increased

Weight decreased

Dysgeusia

Blood alkaline phosphatase increased

Neutrophil count decreased

Muscle spasms

Influenza

Influenza like illness

Myalgia

Peripheral sensory neuropathy

Gamma-glutamyltransferase increased

Hypertension

Platelet count decreased

Depression

Lymphopenia

Gastrooesophageal reflux disease

Abdominal distension

Musculoskeletal pain

Flank pain

Cholangitis

Flatulence

Paraesthesia

General physical health deterioration

Bladder papilloma

Pneumonia pneumococcal

Abdominal infection

Bartholinitis

Pneumonia

Cerebrovascular accident

Pneumothorax

Gastric varices haemorrhage

Large intestinal obstruction

Cholecystitis

Anastomotic haemorrhage

Device occlusion

Stent malfunction

Bronchiolitis

Empyema

Syncope

Incisional hernia

Device dislocation

Obstruction gastric

Cardiac failure

Vascular stenosis

Pleural effusion

Incarcerated inguinal hernia

Urinary tract infection

Hypothyroidism

Transient ischaemic attack

Infusion related reaction

Duodenal perforation

Melaena

Bile duct obstruction

Pancreatitis

100%

80%

60%

40%

20%

Study treatment Arm

Olaparib 300 mg Twice Daily (bd)

Placebo

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

0 / 19Eligibility criteria met