Olaparib for PAH: a Multicenter Clinical Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pulmonary Arterial Hypertension
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: The design is open-label. A 4-week pre-treatment phase will allow ensuring that patients are on stable doses of medication. Patients will be given progressive doses of olaparib up to 300mg BID for 24 weeks.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
Overall, 20 well-characterized PAH patients that have been stable for >4 months on standard PAH-therapies, as per guidelines will be recruited. The initial Health Canada approval will be obtained. Olaparib will be provided by AstraZeneca Canada, but AZ had no input into the trial design and will not...
Overall, 20 well-characterized PAH patients that have been stable for >4 months on standard PAH-therapies, as per guidelines will be recruited. The initial Health Canada approval will be obtained. Olaparib will be provided by AstraZeneca Canada, but AZ had no input into the trial design and will not be involved in the conduct of the trial, analysis, interpretation of the results or the final manuscript. A 4-week pre-treatment phase will allow ensuring that patients are on stable doses of PAH medication. Given that PAH is a chronic disease and that patients may be at higher risk for drug-related adverse events (e.g. anemia), olaparib will be started at low-dose (100mg BID), then up-titrated weekly by 100mg BID up to 200mg BID (n=5, group 1) or 300mg BID (n=15, group 2) for a total treatment duration (including the up-titration phase) of 24 weeks. Using 100mg and 150mg tablets will allow minimizing the number of tablets taken (e.g. 2 x 150mg tablets BID) or adjusting the dose in case of drug-related adverse events (e.g. 250mg BID using 100mg and 150mg tablets). Patients will be regularly followed to assess whether side effects are observed and whether olaparib can be up-titrated. At baseline and week 24, a cardiac catheterization will assess changes in pulmonary hemodynamics and RV function. An end-of-study visit is planned at week 28 week.
Tracking Information
- NCT #
- NCT03782818
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- AstraZeneca
- Investigators
- Principal Investigator: Steeve Provencher, MD, MSc IUCPQ-UL Principal Investigator: Sébastien Bonnet, PhD IUCPQ-UL Study Director: Pascale Blais-Lecours, PhD IUCPQ-UL