Clinical trial · Interventional
Safety and Efficacy of Everolimus in Metastatic Renal Cell Carcinoma After Failure of First Line Therapy With Sunitinib or Pazopanib
An Open Label, Single Arm Trial to Evaluate Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus After Failure of First Line Therapy With Sunitinib or Pazopanib
NCT01514448CI-TRIAL-00028680completedPhase 4Results postedClinicalTrials.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)
Patients with metastatic renal cell carcinoma (mRCC) who failed first-line therapy with sunitinib or pazopanib was treated with everolimus. Efficacy and safety of everolimus was evaluated in these patients.
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 |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma (mRCC) | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus (RAD001) | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Everolimus
- description
- Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
- interventionNames
- Drug: Everolimus (RAD001)
Primary outcomes (1)
- measure
- Percentage of Progression-free Patients by Month 6
- timeFrame
- Month 6
- description
- Percentage of progression-free patients by month 6 after starting everolimus treatment. For the purpose of the binomial design of the study, a patient being 'progression-free' will be defined as a patient without disease progression by month 6 whereas a subject with progressive disease by month 6 will not be counted as 'progression-free'. The primary variable was derived from radiologic tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.) Disease progression was either 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline (minimum absolute increase 5 mm in sum) or 2) the appearance of a new lesion or 3) the unequivocal progression of non-target lesions overall.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with advanced renal cell carcinoma of a histological or cytological confirmation of clear cell renal carcinoma. * Progression during or after a treatment with sunitinib or pazopanib given in a 1st line treatment situation for mRCC. * Patients scheduled for treatment with everolimus. * Patients with at least one measurable lesion at baseline as per RECIST v1.1. Exclusion Criteria: * Patients who have received \>1 prior systemic treatment for their metastatic RCC. Prior systemic treatment in an adjuvant setting is allowed. * Patients who have previously received systemic mTOR inhibitors (e.g. sirolimus, temsirolimus, everolimus). * Patients who are using other investigational agents or who had received investigational drugs ≤ 2 weeks prior to study treatment start. * Patients unwilling or unable to comply with the protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.