Predicting Severe Toxicity of Targeted Therapies in Elderly Patients With Cancer

NCT ID: NCT02751827

Last Updated: 2025-08-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

312 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-02

Study Completion Date

2019-11-19

Brief Summary

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In order to assess the important issue of the safety of antiangiogenic TKI in geriatric population we set up this project which aims to identify, among clinical, biological, pharmacokinetic data, predictive factors for severe toxicity of antiangiogenic TKI (sunitinib, sorafenib, pazopanib, regorafenib, axitinib) in patients over 70 year-old.

Detailed Description

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This is a prospective cohort with collection of biological samples, including 300 patients \> 70 year-old treated in multicenter with antiangiogenic TKI regularly approved for metastatic cancers. Data on clinical and biological characteristics of the patient, disease and treatment as well as pharmacogenomics will be centrally collected at the beginning of the treatment. Drug exposure-safety analyses will be performed through assessment of drug through levels (Cmin). Primary endpoint is severe toxicity defined as treatment-related death, hospitalization or disruption of treatment for more than three weeks.

Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prospective cohort

Prospective cohort involving patients treated in four distinct centers. Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).

All patients without major violations of the eligibility criteria are included in the eligible population. In case of violation of the eligibility criteria, the steering committee will assess for each patient, whether the violation is minor or major.

All eligible patients who have received at least one TKI administration were included in analysis.

Blood sample

Intervention Type OTHER

One blood sample before treatment initiation (Cycle 1 Day predose) for pharmacogenomics

One blood sample at the end of the firth month of treatment (postdose) for pharmacokinetic

Retrospective cohort A

Retrospective cohort of patients treated at the Institut Bergonié (Bordeaux, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).

All patients without major violations of the eligibility criteria are included in the eligible population. In case of violation of the eligibility criteria, the steering committee will assess for each patient, whether the violation is minor or major.

All eligible patients who have received at least one TKI administration were included in analysis.

No interventions assigned to this group

Retrospective cohort B

Retrospective cohort of patients treated at the Centre Antoine Lacassagne(Nice, France). Patients were treated with a tyrosine kinase inhibitor (TKI) prescribed as part of a marketing authorization (MA).

All patients without major violations of the eligibility criteria are included in the eligible population. In case of violation of the eligibility criteria, the steering committee will assess for each patient, whether the violation is minor or major.

All eligible patients who have received at least one TKI administration were included in analysis.

No interventions assigned to this group

Interventions

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Blood sample

One blood sample before treatment initiation (Cycle 1 Day predose) for pharmacogenomics

One blood sample at the end of the firth month of treatment (postdose) for pharmacokinetic

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 70 years
* Treatment with pazopanib, regorafenib, sorafenib, sunitinib,axitinib in the context of market authorization
* Voluntary signed and dated written informed consent prior to any study specific procedure.

Exclusion Criteria

* Patient treated in a context of clinical trial
* Patient with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient consent
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agence Nationale de sécurité du Médicament

OTHER

Sponsor Role collaborator

Institut Bergonié

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Bergonié

Bordeaux, , France

Site Status

Centre Léon Bérard

Lyon, , France

Site Status

Countries

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France

References

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Lebreton C, Cantarel C, Toulza E, Desgrippes R, Bozec L, Saada E, Ducoulombier A, Tardy M, Paillaud E, Lalet C, Bellera C, Italiano A. Incidence and prognostic factors of clinically meaningful toxicities of kinase inhibitors in older patients with cancer: The PreToxE study. J Geriatr Oncol. 2021 May;12(4):668-671. doi: 10.1016/j.jgo.2020.09.020. Epub 2020 Sep 23.

Reference Type BACKGROUND
PMID: 32978101 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IB 2015-02

Identifier Type: -

Identifier Source: org_study_id

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