NCT04774627

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2021

Completed
Last Updated

September 23, 2021

Status Verified

February 1, 2021

Enrollment Period

20 days

First QC Date

February 25, 2021

Last Update Submit

September 16, 2021

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Interventions

PARP inhibitorDRUG

All patients treated at least with 1 PARPi

Also known as: olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients treated with PARPi and experiencing pancytopenia.

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandre Joachim

Caen, Basse Normandie, 14000, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Poly(ADP-ribose) Polymerase Inhibitorsolaparibrucaparibniraparibtalazoparibveliparibpamiparib

Intervention Hierarchy (Ancestors)

Enzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAntineoplastic AgentsTherapeutic Uses

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 1, 2021

Study Start

February 7, 2021

Primary Completion

February 27, 2021

Study Completion

March 24, 2021

Last Updated

September 23, 2021

Record last verified: 2021-02

Locations

FR(1)