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Pancytopenia Related to PARP Inhibitors (PancytoRIB)

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ClinicalTrials.gov Identifier: NCT04774627
Recruitment Status : Completed
First Posted : March 1, 2021
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Study Description
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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.


Condition or disease Intervention/treatment
Cancer Drug: PARP inhibitor

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 Design
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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Pancytopenia Related to PARP Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database (PancytoRIB)
Actual Study Start Date : February 7, 2021
Actual Primary Completion Date : February 27, 2021
Actual Study Completion Date : March 24, 2021
Groups and Cohorts
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Intervention Details:
  • Drug: PARP inhibitor
    All patients treated at least with 1 PARPi
    Other Name: olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer patients treated with PARPi and experiencing pancytopenia.
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04774627


Locations
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France
Alexandre Joachim
Caen, Basse Normandie, France, 14000
Sponsors and Collaborators
University Hospital, Caen
More Information
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT04774627    
Other Study ID Numbers: Pharmaco 20200210
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: September 23, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancytopenia
Hematologic Diseases
Olaparib
Niraparib
Veliparib
Talazoparib
 Poly(ADP-ribose) Polymerase Inhibitors
Rucaparib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents