Predicting Severe Toxicity of Targeted Therapies in Elderly Patients With Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Institut Bergonié
- Enrollment
- 312
- Locations
- 2
- Primary Endpoint
- Rate of Severe Toxicity
Study Overview
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported