Predicting Severe Toxicity of Targeted Therapies in Elderly Patients With Cancer

NCT02751827 | Completed Results

• 1 other identifier: IB 2015-02
• Study Type: observational
• Target: 312
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

Prospective cohort

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.

Other: Blood sample

Retrospective cohort A

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

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.

Interventions

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

Prospective cohort

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Bergonié: lead
• Agence Nationale de sécurité du Médicament: collaborator

Study Sites (2)

Institut Bergonié

Bordeaux, 33076, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Related 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.

  PMID: 32978101 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Pr Simone Mathoulin-Pelissier
• Organization: Institut Bergonié

S.Mathoulin@bordeaux.unicancer.fr

0556333333

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 26, 2016
• Study Start: February 2, 2016
• Primary Completion: November 19, 2019
• Study Completion: November 19, 2019
• Last Updated: August 24, 2025
• Results First Posted: June 25, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)