NCT02751827

Predicting Severe Toxicity of Targeted Therapies in Elderly Patients With Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 312 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
OTHER	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

Timeline

• Start date: 2016-02-02
• Primary completion: 2019-11-19
• Completion: 2019-11-19
• First posted: 2016-04-26
• Last updated: 2025-08-24
• Results posted: 2021-06-25

Locations

2 sites across 1 country: France