Predicting Severe Toxicity of Targeted Therapies in Elderly Patients With Cancer
NCT ID: NCT02751827
Last Updated: 2025-08-24
Study Results
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View full resultsBasic Information
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COMPLETED
312 participants
OBSERVATIONAL
2016-02-02
2019-11-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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
Eligibility Criteria
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Inclusion Criteria
* 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 with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient consent
70 Years
ALL
No
Sponsors
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Agence Nationale de sécurité du Médicament
OTHER
Institut Bergonié
OTHER
Responsible Party
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Locations
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Institut Bergonié
Bordeaux, , France
Centre Léon Bérard
Lyon, , France
Countries
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IB 2015-02
Identifier Type: -
Identifier Source: org_study_id
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