Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01598038

Enrollment

Registered

2012-05-15

Start date

2012-04-30

Completion date

2015-12-31

Last updated

2017-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma

Keywords

cancer, renal, Afinitor, pharmacokinetics

Brief summary

The investigators hypothesize everolimus toxicities are linked to pharmacokinetic variabilities of everolimus. Thus, early detection of clinical or biological risk factors will lead to personalized dosage treatment and permit a better tolerance without altering efficacy.

Interventions

OTHERBlood sample

Everolimus is determined in whole blood by validated high performance liquid chromatography with tandem mass spectrometry after protein precipitation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients aged ≥ 18 year-old. 2. Histologically documented renal cell carcinoma whatever the type. 3. One or two prior therapy with cytokines and/or VEFG-ligand inhibitors are permitted. 4. Patients with an indication to receive everolimus treatment 5. Patients able and willing to give written informed consent, before the first screening procedure.

Exclusion criteria

1. Patients currently receiving chemotherapy or immunotherapy 2. Prior treatment with temsirolimus 3. Contraindication in everolimus : * Hypersensitivity to the active substance, to other rapamycin derivatives or to any of the excipients. * Patients with severe hepatic impairment (Child-Pugh class C) * Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 4. Pregnant or breastfeeding women 5. Patients unwilling to or unable to comply with the protocol.

Design outcomes

Primary

Measure	Time frame	Description
Find a relationship between everolimus through blood level and treatment safety.	2 years	We hypothesize everolimus toxicities are linked to pharmacokinetic variabilities of everolimus. Thus, early detection of clinical or biological risk factors will lead to personalised dosage treatment and permit a better tolerance without altering efficacy.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026