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

Not Applicable

Terminated

• Conditions: Renal Cell Carcinoma
• Interventions: Other: Blood sample

• Registration Number: NCT01598038
• Lead Sponsor: Centre Francois Baclesse

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-10
• Study First Submitted QC: 2012-05-14
• Study First Posted: 2012-05-15
• Primary Completion: 2015-03
• Study Completion: 2015-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Afinitor	Blood sample	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Centre François Baclesse; 🇫🇷 Caen, France