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NCT Number: NCT02751827

Predicting Severe Toxicity of Targeted Therapies in Elderly Patients With Cancer

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.

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Key information

Conditions

Cancer Neoplasms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Bergonié, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

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

Primary outcomes

  1. Rate of Severe Toxicity

    Time frame: During treatment, up to 12 months or within 4 weeks following definitive treatment discontinuation, an average of 5 months.

    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).

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Collaborators

  • Agence Nationale de sécurité du Médicament

Registry information

Acronym: PreToxE

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 26, 2016
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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