Renal Cell CarcinomaNCT01598038
Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma
A study testing Blood sample in people with Renal Cell Carcinoma, run by Centre Francois Baclesse at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre François Baclesse
Caen, 14076
Institut Gustave Roussy
Villejuif, 94805
About this study
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.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Blood sample
- Keywords
- cancer, renal, Afinitor, pharmacokinetics
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Also called Assessment will be performed at 15 days, 1, 3 months then every three months until the end of the treatment
Everolimus is determined in whole blood by validated high performance liquid chromatography with tandem mass spectrometry after protein precipitation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Caen
- Responsible party
- Sponsor
- Investigators
- SEVIN Emmanuel, MD, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598038
- Sponsor's protocol ID
- PEVERENAL
- Status last verified
- Jul 2017
- First submitted
- 10 May 2012
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01598038
- Acronym / sponsor ID
- PEVERENAL
- Conditions
- Renal Cell Carcinoma
- Keywords
- cancer, renal, Afinitor, pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- University Hospital, Caen
- Study start
- Apr 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Afinitor | No intervention | Other: Blood sampleThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Patients currently receiving chemotherapy or immunotherapy
- Prior treatment with temsirolimus
- Contraindication in everolimus :
- Pregnant or breastfeeding women
- Patients unwilling to or unable to comply with the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleAlso: Assessment will be performed at 15 days, 1, 3 months then every three months until the end of the treatmentEverolimus is determined in whole blood by validated high performance liquid chromatography with tandem mass spectrometry after protein precipitation | Other | Afinitor |
Primary outcome
Find a relationship between everolimus through blood level and treatment safety.
Time frame: 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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEVIN Emmanuel, MD principal investigator
Centre François Baclesse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Renal Cell Carcinoma, run by Centre Francois Baclesse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Find a relationship between everolimus through blood level and treatment safety. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.