Pancytopenia Related to PARP Inhibitors (PancytoRIB)

Completed

• Conditions: Cancer

• Registration Number: NCT04774627
• Lead Sponsor: University Hospital, Caen

Brief Summary

Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious adverse events such as pancytopenia. Today, data about pancytopenia are scarce.

The objective was to investigate reports of pancytopenia adverse events related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib and pamiparib using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.

Detailed Description

Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of pancytopenia related to PARPi.

Study Timeline

• Status Verified: 2021-02
• Study Start: 2021-02-07
• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-25
• Primary Completion: 2021-02-27
• Study First Posted: 2021-03-01
• Study Completion: 2021-03-24
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,
• patients treated with at least 1 PARPi (with ATC classification system): olaparib (ATC L01XX46), niraparib (ATC L01XX54), rucaparib (ATC L01XX55), talazoparib (ATC L01XX60), veliparib (none) and pamiparib (none).

Exclusion Criteria

chronology not compatible between the PARPi and adverse event.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pancytopenia reports related to PARPi.	From inception to Feb, 2021	Identification of the pancytopenia adverse event related to PARP inhibitors reported in the World Health Organization's (WHO) database of individual safety case reports.

Secondary Outcome Measures

Name	Time	Method
Description of the latency period since first PARPi exposure.	From inception to Feb, 2021
Description of the fatality rate.	From inception to Feb, 2021
Description of patients who experienced co-reported adverse events	From inception to Feb, 2021

Trial Locations

Locations (1)

Alexandre Joachim; 🇫🇷 Caen, Basse Normandie, France