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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01598038 |
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Date of registration:
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10/05/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma
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Scientific title:
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Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma |
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Date of first enrolment:
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April 2012 |
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Target sample size:
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41 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01598038 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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SEVIN Emmanuel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre François Baclesse |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Renal Cell Carcinoma
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Intervention(s)
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Other: Blood sample
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Primary Outcome(s)
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Find a relationship between everolimus through blood level and treatment safety.
[Time Frame: 2 years]
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Secondary ID(s)
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PEVERENAL
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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