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PARP Inhibitor

Olaparib for Pulmonary Arterial Hypertension (OPTION Trial)

Phase 1 & 2

Recruiting

Led By Steeve Provencher, MD, MSc

Research Sponsored by Laval University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male patients must use a condom during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential

WHO functional class II or III

Must not have

Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors

Presence of ≥3 risk factors for heart failure with preserved ejection fraction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and visits 1, 3, 4, 5, 6 and 7.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a drug that has been approved for ovarian cancer is also safe to use for pulmonary arterial hypertension and if it is effective in treating the disease.

Who is the study for?

This trial is for adults with Pulmonary Arterial Hypertension (PAH) who are stable on current PAH therapy, have a specific range of blood pressure and organ function, and can commit to contraception. Excluded are those recently in other trials, with certain diseases like liver cirrhosis or cancer, uncontrolled medical issues, or unable to take oral meds.

What is being tested?

The study tests Olaparib's safety in treating PAH. It's an early-phase trial aiming to see if the drug that helps treat ovarian cancer by protecting against DNA damage could also benefit PAH patients. Participants will be monitored for both safety and initial signs of effectiveness.

What are the potential side effects?

While not specified here, common side effects of Olaparib include nausea, fatigue, respiratory infections like coughing or shortness of breath; it may also affect bone marrow function leading to blood disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I will use protection during sex for 3 months after my last olaparib dose.

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My heart or lung condition mildly or moderately affects my daily activities.

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I am postmenopausal or cannot become pregnant.

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My PAH is caused by genetics, drugs, toxins, or is related to a connective tissue disease.

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I can walk 150 meters or more without stopping, twice.

Exclusion Criteria

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

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I am not taking strong or moderate CYP3A inhibitor medications.

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I have 3 or more risk factors for a specific type of heart failure.

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I have had a bacterial infection in the last 30 days.

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

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I have liver problems but not related to right ventricle failure.

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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

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

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I have been diagnosed with high blood pressure.

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I have had a bone marrow or cord blood transplant in the past.

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I have a history of cancer.

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I do not have any serious, uncontrolled health issues or infections.

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I have had a condition where my lymphocytes grow abnormally.

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I cannot take pills by mouth or have stomach issues that affect medication absorption.

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I have had a severe spike in blood pressure before.

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I have a type of high blood pressure that affects the arteries in my lungs.

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I have severe lung disease that affects my breathing.

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I have active hepatitis B or C.

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I have never been treated with a PARP inhibitor like Olaparib.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and visits 1, 3, 4, 5, 6 and 7.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and visits 1, 3, 4, 5, 6 and 7.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and visits 1, 3, 4, 5, 6 and 7. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Occurrence of treatment-emergent AEs at week 24

Secondary study objectives

6-min walk test (6MWT)

Health related Quality of Life (HRQoL)

NT-proBNP levels

+1 more

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

Dizziness

Hyperglycaemia

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

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: OlaparibExperimental Treatment1 Intervention

After a 4-week pre-treatment phase to ensure that patients are on stable doses of PAH medication, patients will be given progressive doses of olaparib up to 300 mg BID for 24 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2190

0 / 23Eligibility criteria met