Clinical trial · Interventional
Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma
NCT01598038CI-TRIAL-00028823terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- NO_INTERVENTION
- label
- Afinitor
- 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.
- interventionNames
- Other: Blood sample
Primary outcomes (1)
- measure
- Find a relationship between everolimus through blood level and treatment safety.
- timeFrame
- 2 years
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.