Clinical trial NCT02751827: Predicting Severe Toxicity of Targeted Therapies in Elderly Patients With Cancer
Official title: Predicting Severe Toxicity of Targeted Therapies in Elderly Patients With Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: Agence Nationale de sécurité du Médicament
First posted: 2016-04-26
Enrollment: 312
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Severe Toxicity
timeFrame: During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
city: Lyon Cedex 08
country: France
facility: Centre Léon Bérard
Study officials:
References:
citation: 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.