NCT01598038

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

2.9 years

First QC Date

May 10, 2012

Last Update Submit

July 27, 2017

Conditions

Renal Cell Carcinoma

Keywords

cancerrenalAfinitorpharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

    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.

    2 years

Study Arms (1)

Afinitor

NO INTERVENTION

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.

Other: Blood sample

Interventions

Blood sampleOTHER

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

Also known as: Assessment will be performed at 15 days, 1, 3 months then every three months until the end of the treatment
Afinitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients currently receiving chemotherapy or immunotherapy
  • Prior treatment with temsirolimus
  • 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.
  • Pregnant or breastfeeding women
  • Patients unwilling to or unable to comply with the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre François Baclesse

Caen, 14076, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Carcinoma, Renal CellNeoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • SEVIN Emmanuel, MD

    Centre François Baclesse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2012

First Posted

May 15, 2012

Study Start

April 1, 2012

Primary Completion

March 1, 2015

Study Completion

December 1, 2015

Last Updated

July 28, 2017

Record last verified: 2017-07

Locations

FR(2)