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

Primary Purpose

Renal Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
RAD001
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Renal cell carcinoma, Non-clear cell, RAD001, Metastatic, non-clear cell, renal cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RAD001

Arm Description

RAD001 10mg/day

Outcomes

Primary Outcome Measures

Progression-free survival
It is the time from treatment initiation until disease progression.

Secondary Outcome Measures

Response rate
It is the percentage of patients whose cancer shrinks or disappears after treatment.
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.
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.
Metabolic response rate by FDG-PET
It is assesed target lesions and non- target lesions by FDG-PET.
Safety

Full Information

First Posted
January 27, 2009
Last Updated
November 6, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00830895
Brief Title
RAD001 for Non-clear Cell Renal Cell Carcinoma (RCC)
Official Title
A Phase II Study to Evaluate the Efficacy of RAD001 in Metastatic Non-clear Cell Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Renal cell carcinoma, Non-clear cell, RAD001, Metastatic, non-clear cell, renal cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RAD001
Arm Type
Experimental
Arm Description
RAD001 10mg/day
Intervention Type
Drug
Intervention Name(s)
RAD001
Intervention Description
RAD001 10mg/day
Primary Outcome Measure Information:
Title
Progression-free survival
Description
It is the time from treatment initiation until disease progression.
Time Frame
2 months, 4 months, 6 months
Secondary Outcome Measure Information:
Title
Response rate
Description
It is the percentage of patients whose cancer shrinks or disappears after treatment.
Time Frame
2 months, 4 months, 6 months
Title
Disease-control rate
Description
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.
Time Frame
2 months, 4 months, 6 months
Title
Overall survival
Description
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.
Time Frame
2 months, 4 months, 6 months
Title
Metabolic response rate by FDG-PET
Description
It is assesed target lesions and non- target lesions by FDG-PET.
Time Frame
2 months, 4 months, 6 months
Title
Safety
Time Frame
monthly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed non-clear cell renal cell carcinoma (papillary, chromophobe, collecting duct, oncocytic subtype, sarcomatoid mainly) Subjects with metastatic legion Subjects aged 18 years or older Subjects whose ECOG performance status is 0 or 1 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 Subjects who understand and provide a written informed consent Exclusion Criteria: Subjects who have been administered an mTOR inhibitor 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 Subjects who participated in a clinical study using the study medication within 30 days before randomization Subjects with clinically uncontrolled central nervous system (CNS) metastasis Subjects with life expectancy of less than 3 months Subjects with interstitial pulmonary disease Subjects whose QTc interval is prolonged (QTc > 450 msec for male or > 470 msec for female) 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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23180114
Citation
Koh 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.
Results Reference
derived

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

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