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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and visits 1, 3, 4, 5, 6 and 7.
Awards & highlights
OPTION Trial 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.Check my eligibility
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.See study design
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.
OPTION Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I will use protection during sex for 3 months after my last olaparib dose.
Select...
My heart or lung condition mildly or moderately affects my daily activities.
Select...
I am postmenopausal or cannot become pregnant.
Select...
My PAH is caused by genetics, drugs, toxins, or is related to a connective tissue disease.
Select...
I can walk 150 meters or more without stopping, twice.
OPTION Trial 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occurrence of treatment-emergent AEs at week 24
Secondary outcome measures
6-min walk test (6MWT)
Health related Quality of Life (HRQoL)
NT-proBNP levels
+1 moreSide 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
OPTION 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
~2140
Find a Location
Who is running the clinical trial?
Laval UniversityLead Sponsor
417 Previous Clinical Trials
172,252 Total Patients Enrolled
6 Trials studying Pulmonary Arterial Hypertension
160 Patients Enrolled for Pulmonary Arterial Hypertension
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,453,397 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
72 Patients Enrolled for Pulmonary Arterial Hypertension
AstraZenecaIndustry Sponsor
4,265 Previous Clinical Trials
288,605,262 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have started or plan to start a heart and lung rehab program within the last 12 weeks.I will use protection during sex for 3 months after my last olaparib dose.I am not taking strong or moderate CYP3A inhibitor medications.I have 3 or more risk factors for a specific type of heart failure.I will use protection during sex and avoid donating sperm while on olaparib and for 3 months after.I do not drink grapefruit juice while on my current medication.I have had a condition where my lymphocytes grow abnormally.My heart or lung condition mildly or moderately affects my daily activities.My PAH is caused by genetics, drugs, toxins, or is related to a connective tissue disease.I have had a bone marrow or cord blood transplant in the past.I do not have any serious, uncontrolled health issues or infections.I have active hepatitis B or C.I have never been treated with a PARP inhibitor like Olaparib.My heart/blood pressure medication has been stable for over 4 months.People with weakened immune systems.I have had a bacterial infection in the last 30 days.I have not had major surgery in the last 2 weeks.I have liver problems but not related to right ventricle failure.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I have been diagnosed with high blood pressure.I am not taking any strong or moderate drugs that affect liver enzymes.Women who are currently breastfeeding.My cancer was diagnosed less than a year ago.Your blood pressure is lower than 90 mmHg when the heart is pumping.I have a history of cancer.I have had a recent heart failure episode within the last 3 months.I cannot take pills by mouth or have stomach issues that affect medication absorption.I have had a severe spike in blood pressure before.I have a type of high blood pressure that affects the arteries in my lungs.I have severe lung disease that affects my breathing.Your heart test shows uncontrolled, fixable heart problems.I have not had a blood transfusion in the last 4 months.I am postmenopausal or cannot become pregnant.You are allergic to olaparib or any of the ingredients in the product.I haven't had any cancer, except for skin cancer, in the last 5 years.Your blood pressure in the arteries of your lungs is too high, and you don't have a specific reaction to help lower it.I can walk 150 meters or more without stopping, twice.My organ and bone marrow functions are normal.You are expected to live for at least 28 more weeks.Your body mass index (BMI) is between 18 and 40.
Research Study Groups:
This trial has the following groups:- Group 1: Olaparib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Is this experiment open to participants aged 50 or above?
"To be eligible for this clinical trial, patients must have an age between 18 and 75. Additionally, there are 65 trials specifically targeting those under the legal age of consent as well 846 studies open to individuals aged over 65."
Answered by AI
Are there any available openings for participants in this experiment?
"Affirmative, the information publicly available on clinicaltrials.gov attests to this medical study actively enrolling volunteers. Posted in November 2019 and last updated May 2022, 20 willing participants are being accepted across 3 sites."
Answered by AI
Is this an unprecedented exploration of the topic?
"Extensively studied since 2005, Olaparib's initial clinical trial was sponsored by AstraZeneca and involved 98 participants. After receiving Phase 1 drug approval in the wake of this study, there are currently 188 worldwide trials for this medication being conducted across 1468 cities and 59 countries."
Answered by AI
What criteria makes someone a potential candidate for this experiment?
"This clinical trial is calling for 20 individuals, aged 18 to 75 and suffering from pulmonary arterial hypertension. Necessary criteria include providing written informed consent, a hemoglobin level of 10.0 g/dL without blood transfusion within the past 28 days, being able to provide signed informed consent with compliance towards protocol requirements and restrictions listed in the ICF form; an identified cause or factor associated with PAH such as idiopathic, hereditary etc.; mean PA pressure ≥25mmHg, PVR >480 dyn.s cm-5 , WHO functional class II or III (the traditional inclusion criterion in all PAH"
Answered by AI
What is the sample size of this investigation?
"A total of 20 eligible patients are sought out for this medical study. Interested participants can apply to trial sites such as IUCPQ-UL in Quebec City or UHN-Toronto General Hospital in Toronto, Ontario."
Answered by AI
To what extent has Olaparib been investigated in other research?
"Olaparib was initially investigated in 2005 at Research Site, with a total of 63 completed trials. Currently 188 active clinical studies are searching for participants, the majority centered around Quebec City in the province of Quebec."
Answered by AI
What therapeutic purpose does Olaparib fulfill?
"Olaparib is an effective treatment method for conditions such as advance directives, malignant neoplasm of ovary and primary peritoneal cancer."
Answered by AI
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