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

Renal Cell Carcinoma Clinical Trial

Official title:

A Phase II Study to Evaluate the Efficacy of RAD001 in Metastatic Non-clear Cell Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830895
• Other study ID #: SNUH-RENAL-0901
• Status: Completed
• Phase: Phase 2
• Start date: January 2009
• Est. completion date: December 2012

Study information

• Verified date: November 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• RAD001
RAD001 10mg/day

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	It is the time from treatment initiation until disease progression.	2 months, 4 months, 6 months
Secondary	Response rate	It is the percentage of patients whose cancer shrinks or disappears after treatment.	2 months, 4 months, 6 months
Secondary	Disease-control rate	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.	2 months, 4 months, 6 months
Secondary	Overall survival	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.	2 months, 4 months, 6 months
Secondary	Metabolic response rate by FDG-PET	It is assesed target lesions and non- target lesions by FDG-PET.	2 months, 4 months, 6 months
Secondary	Safety		monthly