Clinical trial · Interventional
RAD001 for Non-clear Cell Renal Cell Carcinoma (RCC)
A Phase II Study to Evaluate the Efficacy of RAD001 in Metastatic Non-clear Cell Renal Cell Carcinoma
NCT00830895CI-TRIAL-00062087completedPhase 2ClinicalTrials.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)
To assess the efficacy and safety of RAD001 (everolimus) in non-clear cell renal cell carcinoma
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 |
|---|---|---|---|
| RAD001 | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RAD001
- description
- RAD001 10mg/day
- interventionNames
- Drug: RAD001
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 2 months, 4 months, 6 months
- description
- It is the time from treatment initiation until disease progression.
Secondary outcomes (5)
- measure
- Response rate
- timeFrame
- 2 months, 4 months, 6 months
- description
- It is the percentage of patients whose cancer shrinks or disappears after treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed non-clear cell renal cell carcinoma (papillary, chromophobe, collecting duct, oncocytic subtype, sarcomatoid mainly) 2. Subjects with metastatic legion 3. Subjects aged 18 years or older 4. Subjects whose ECOG performance status is 0 or 1 5. Subjects who have laboratory value below; Hematology * Neutrophil \>= 1.5 x 109/L * Platelet \>= 75 x 109/L * Hemoglobin \>= 9 g/dL Liver function tests * Total bilirubin ≤ 1.5 xULN * AST, ALT ≤ 2.5 xULN * Alkaline phosphatase ≤ 2.5 xULN Renal function tests * Creatinine clearance \>= 30 mL/min 6. Subjects who understand and provide a written informed consent Exclusion Criteria: 1. Subjects who have been administered an mTOR inhibitor 2. Pregnant or nursing women, and women of childbearing potential must use appropriate contraception for the study period and the result of their pregnancy test performed within 14 days before enrollment must be negative 3. Subjects who participated in a clinical study using the study medication within 30 days before randomization 4. Subjects with clinically uncontrolled central nervous system (CNS) metastasis 5. Subjects with life expectancy of less than 3 months 6. Subjects with interstitial pulmonary disease 7. Subjects whose QTc interval is prolonged (QTc \> 450 msec for male or \> 470 msec for female) 8. Other serious diseases or medical conditions Heart disease unstable despite treatment History of myocardial infarction within six months before the study History of serious neurological or psychological disorder including dementia or seizure Active peptic ulcer which cannot be controlled by a drug
References
Publications (1)
- DERIVEDKoh Y, Lim HY, Ahn JH, Lee JL, Rha SY, Kim YJ, Kim TM, Lee SH. Phase II trial of everolimus for the treatment of nonclear-cell renal cell carcinoma. Ann Oncol. 2013 Apr;24(4):1026-31. doi: 10.1093/annonc/mds582. Epub 2012 Nov 23. PMID 23180114