Predicting Severe Toxicity of Targeted Therapies in Elderly Patients With Cancer (PreToxE)

Institut Bergonié

Status: Completed

Conditions: Cancer

Treatments: Other: Blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT02751827

IB 2015-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 312 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

312 participants in 3 patient groups

Prospective cohort

Description:

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.

Treatment:

Other: Blood sample

Retrospective cohort A

Description:

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.

Retrospective cohort B

Description:

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.