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Completed

NCT Number: NCT04774627

Pancytopenia Related to PARP Inhibitors (PancytoRIB)

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.

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Key information

Conditions

Cancer Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexandre Joachim

Caen, Basse Normandie, 14000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PARP inhibitor

Drug

All patients treated at least with 1 PARPi

Other names: olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib

Primary outcomes

  1. Pancytopenia reports related to PARPi.

    Time frame: 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 outcomes

  1. Description of the latency period since first PARPi exposure.

    Time frame: From inception to Feb, 2021

  2. Description of the fatality rate.

    Time frame: From inception to Feb, 2021

  3. Description of patients who experienced co-reported adverse events

    Time frame: From inception to Feb, 2021

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2021
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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