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

Primary Purpose

Renal Cell Carcinoma

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring cancer, renal, Afinitor, pharmacokinetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Centre François Baclesse
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Afinitor

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2012
Last Updated
July 27, 2017
Sponsor
Centre Francois Baclesse
Collaborators
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT01598038
Brief Title
Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma
Official Title
Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
University Hospital, Caen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
cancer, renal, Afinitor, pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Afinitor
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Blood sample
Other Intervention Name(s)
Assessment will be performed at 15 days, 1, 3 months then every three months until the end of the treatment
Intervention Description
Everolimus is determined in whole blood by validated high performance liquid chromatography with tandem mass spectrometry after protein precipitation
Primary Outcome Measure Information:
Title
Find a relationship between everolimus through blood level and treatment safety.
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SEVIN Emmanuel, MD
Organizational Affiliation
Centre François Baclesse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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