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

18 Years
Open (Enrolling)
Renal Cell Carcinoma

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Trial Information

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

Inclusion Criteria:

1. Patients aged ≥ 18 year-old.

2. Histologically documented renal cell carcinoma.

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

4. Pregnant or breastfeeding women

5. Patients unwilling to or unable to comply with the protocol.

Type of Study:


Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Find a relationship between everolimus through blood level and treatment safety.

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

SEVIN Emmanuel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre François Baclesse


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

April 2012

Completion Date:

April 2015

Related Keywords:

  • Renal Cell Carcinoma
  • cancer
  • renal
  • Afinitor
  • pharmacokinetics
  • Carcinoma
  • Carcinoma, Renal Cell