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

This study is currently recruiting participants.
Verified February 2013 by Centre Francois Baclesse
Sponsor:
Collaborator:
University Hospital, Caen
Information provided by (Responsible Party):
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01598038
First received: May 10, 2012
Last updated: February 7, 2013
Last verified: February 2013
History of Changes

May 10, 2012
February 7, 2013
April 2012
April 2014   (final data collection date for primary outcome measure)
Find a relationship between everolimus through blood level and treatment safety. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01598038 on ClinicalTrials.gov Archive Site
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Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma
Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma

The investigators 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 permit a better tolerance without altering efficacy.
Not Provided
Interventional
Not Provided
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Cell Carcinoma
Other: Blood sample
Everolimus is determined in whole blood by validated high performance liquid chromatography with tandem mass spectrometry after protein precipitation
Other Name: Assessment will be performed at 15 days, 1, 3 months then every three months until the end of the treatment
No Intervention: Afinitor

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.

Intervention: Other: Blood sample
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
97
April 2015
April 2014   (final data collection date for primary outcome measure)

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 product.
  4. Pregnant or breastfeeding women
  5. Patients unwilling to or unable to comply with the protocol.
Both
18 Years and older
No
Contact: SEVIN Emmanuel, MD (+33) 2 31 45 50 02 e.sevin@baclesse.fr
France
 
NCT01598038
PEVERENAL
Yes
Centre Francois Baclesse
Centre Francois Baclesse
University Hospital, Caen
Principal Investigator: SEVIN Emmanuel, MD Centre François Baclesse
Centre Francois Baclesse
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP