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

Phase 2

Completed

• Conditions: Renal Cell Carcinoma
• Interventions: Drug: RAD001

• Registration Number: NCT00830895
• Lead Sponsor: Seoul National University Hospital

Brief Summary

To assess the efficacy and safety of RAD001 (everolimus) in non-clear cell renal cell carcinoma

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-27
• Study First Submitted QC: 2009-01-27
• Study First Posted: 2009-01-28
• Primary Completion: 2010-10
• Study Completion: 2012-12
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-06
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RAD001	RAD001	RAD001 10mg/day

Primary Outcome Measures

Name	Time	Method
Progression-free survival	2 months, 4 months, 6 months	It is the time from treatment initiation until disease progression.

Secondary Outcome Measures

Name	Time	Method
Response rate	2 months, 4 months, 6 months	It is the percentage of patients whose cancer shrinks or disappears after treatment.
Metabolic response rate by FDG-PET	2 months, 4 months, 6 months	It is assesed target lesions and non- target lesions by FDG-PET.
Safety	monthly
Disease-control rate	2 months, 4 months, 6 months	It is the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention.
Overall survival	2 months, 4 months, 6 months	The length of time from either the date of diagnosis or the start of treatment for a disease that patients diagnosed with the disease are still alive.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of