RAD001 for Non-clear Cell Renal Cell Carcinoma (RCC)

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2022
• Main ID: NCT00830895
• Date of registration: 27/01/2009
• Prospective Registration: No
• Primary sponsor: Seoul National University Hospital
• Public title: RAD001 for Non-clear Cell Renal Cell Carcinoma (RCC)
• Scientific title: A Phase II Study to Evaluate the Efficacy of RAD001 in Metastatic Non-clear Cell Renal Cell Carcinoma
• Date of first enrolment: January 2009
• Target sample size: 49
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00830895
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Korea, Republic of

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Renal Cell Carcinoma

Intervention(s)

Drug: RAD001

Primary Outcome(s)

Progression-free survival [Time Frame: 2 months, 4 months, 6 months]

Secondary Outcome(s)

Disease-control rate [Time Frame: 2 months, 4 months, 6 months]

Overall survival [Time Frame: 2 months, 4 months, 6 months]

Safety [Time Frame: monthly]

Response rate [Time Frame: 2 months, 4 months, 6 months]

Metabolic response rate by FDG-PET [Time Frame: 2 months, 4 months, 6 months]

Secondary ID(s)

SNUH-RENAL-0901

Source(s) of Monetary Support

Please refer to primary and secondary sponsors