Identification of PAthways of Kinase Inhibitors TOxicity

Kinase Inhibitors Toxicity Clinical Trial

— PAKITO  

Official title:

Identification of PAthways of Kinase Inhibitors TOxicity Through Patient Databases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03896139
• Other study ID #: CIC1421-1906
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: March 2019
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The investigators are identifying clinical diagnoses and toxicities associated with kinase inhibitors prescription. This identification will be applied will be applied in an electronic-health-record (EHR) cohort including North American and European.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient treated with a kinase inhibitor

• Patient identified in the VUMC EHR cohort or having a toxicity reported in the VigiBase

Exclusion Criteria:

Related Conditions & MeSH terms

• Kinase Inhibitors Toxicity

Intervention

Drug:
• Kinase inhibitor
Patients treated with kinase inhibitors for cancer or other conditions

Locations

Country	Name	City	State
France	AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere	Vanderbilt University Medical Center

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the incidence of kinase inhibitor (KIs) induced toxicities in health records and their associations with co-medications to identify new mechanisms of drug induced toxicity	Identification of a mechanism of a toxicity associated with a KI using comedications and comparing it to reported outcomes	population included in VUMC database and/or WHO's database resource up to march 2019