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

Centre Francois Baclesse

Status: Terminated

Conditions: Renal Cell Carcinoma

Treatments: Other: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT01598038

PEVERENAL

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Afinitor

No Intervention group

Description:

The recommended dose of Afinitor is 10 mg everolimus once daily, at fixed hour.Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs. In case of frail patients, treatment could be initiated at a lower daily-dose (5mg/d for example) and then increase if tolerance is acceptable.

Treatment:

Other: Blood sample