Pancytopenia Related to PARP Inhibitors (PancytoRIB)

Cancer Clinical Trial

Official title:

Pancytopenia Related to PARP Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database (PancytoRIB)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04774627
• Other study ID #: Pharmaco 20200210
• Status: Completed
• Start date: February 7, 2021
• Est. completion date: March 24, 2021

Study information

• Verified date: February 2021
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 24, 2021
• Est. primary completion date: February 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Pancytopenia

Intervention

Drug:
• PARP inhibitor
All patients treated at least with 1 PARPi

Locations

Country	Name	City	State
France	Alexandre Joachim	Caen	Basse Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pancytopenia reports related to PARPi.	Identification of the pancytopenia adverse event related to PARP inhibitors reported in the World Health Organization's (WHO) database of individual safety case reports.	From inception to Feb, 2021
Secondary	Description of the latency period since first PARPi exposure.		From inception to Feb, 2021
Secondary	Description of the fatality rate.		From inception to Feb, 2021
Secondary	Description of patients who experienced co-reported adverse events		From inception to Feb, 2021