Predicting Severe Toxicity of Targeted Therapies in Elderly Patients With Cancer

Cancer Clinical Trial

— PreToxE  

Official title:

Predicting Severe Toxicity of Targeted Therapies in Elderly Patients With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02751827
• Other study ID #: IB 2015-02
• Status: Completed
• Start date: February 2, 2016
• Est. completion date: November 19, 2019

Study information

• Verified date: June 2021
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: November 19, 2019
• Est. primary completion date: November 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux
France	Centre Léon Bérard	Lyon Cedex 08

Sponsors (2)

Lead Sponsor	Collaborator
Institut Bergonié	Agence Nationale de sécurité du Médicament

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Severe Toxicity	Severe toxicity was defined as any TKI-related adverse events (AE) leading to any one of the following events: death, persistent or significant disability/incapacity (defined as a permanent physical or mental impairmentwhich seriously limits one or more functional capacities such as mobility, communication, self-care, self-direction, or interpersonal skills), unexpected hospitalization, drug discontinuation for more than three weeks or definitive discontinuation.; All adverse events (AE) were graded as per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.0).	During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months.

External Links

•   Journal of Geriatric Oncology