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

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ClinicalTrials.gov Identifier: NCT02751827
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
Agence Nationale de sécurité du Médicament
Information provided by (Responsible Party):
Institut Bergonié

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 75 year-old.

Condition or disease Intervention/treatment
Cancer Other: Blood sample

Detailed Description:
This is a prospective cohort with collection of biological samples, including 300 patients > 75 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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Severe Toxicity of Targeted Therapies in Elderly Patients With Cancer
Study Start Date : February 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Group/Cohort Intervention/treatment
Prospective cohort - Blood sample
All patients without major violations of the eligibility criteria are included in this population. In case of violation of the eligibility criteria, the steering committee will assess for each patient, whether the violation is minor or major.
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





Primary Outcome Measures :
  1. Toxicity [ Time Frame: During treatment or within 4 weeks following definitive treatment discontinuation ]
    Severe toxicity is defined as an adverse event (NCI CTCAEv4.03)


Secondary Outcome Measures :
  1. Non-progression [ Time Frame: at 6-months ]
    Non-progression is defined as complete response (CR), partial response (PR) or stable disease (SD) as per RECIST 1.1

  2. Progression-free survival (PFS) [ Time Frame: at 12 months ]
    Progression-free survival (PFS) is defined as time from treatment initiation to disease progression (RECIST v1.1) or death whoever occurs first.


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



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients without major violations of the eligibility criteria are included in this population. In case of violation of the eligibility criteria, the steering committee will assess for each patient, whether the violation is minor or major.
Criteria

Inclusion Criteria:

  • Age ≥ 75 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751827


Contacts
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Contact: Antoine ITALIANO, MD, PhD a.italiano@bordeaux.unicancer.fr
Contact: Simone MATHOULIN-PELISSIER, MD,PhD s.mathoulin@bordeaux.unicancer.fr

Locations
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France
Institut Bergonié Recruiting
Bordeaux, France, 33076
Contact: Antoine ITALIANO, MD,PhD         
Principal Investigator: Antoine ITALIANO, MD,PhD         
Centre Léon Bérard Not yet recruiting
Lyon Cedex 08, France, 69373
Contact: Jean-Yves BLAY, MD, PhD         
Principal Investigator: Jean-Yves BLAY, MD, PhD         
Sponsors and Collaborators
Institut Bergonié
Agence Nationale de sécurité du Médicament

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Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT02751827     History of Changes
Other Study ID Numbers: IB 2015-02
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No