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

November 6, 2022 updated by: Se-Hoon Lee, Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RAD001
RAD001 10mg/day
Drug: RAD001
RAD001 10mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 2 months, 4 months, 6 months
It is the time from treatment initiation until disease progression.
2 months, 4 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 2 months, 4 months, 6 months
It is the percentage of patients whose cancer shrinks or disappears after treatment.
2 months, 4 months, 6 months
Disease-control rate
Time Frame: 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.
2 months, 4 months, 6 months
Overall survival
Time Frame: 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.
2 months, 4 months, 6 months
Metabolic response rate by FDG-PET
Time Frame: 2 months, 4 months, 6 months
It is assesed target lesions and non- target lesions by FDG-PET.
2 months, 4 months, 6 months
Safety
Time Frame: monthly
monthly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 27, 2009

First Submitted That Met QC Criteria

January 27, 2009

First Posted (Estimate)

January 28, 2009

Study Record Updates

Last Update Posted (Actual)

November 9, 2022

Last Update Submitted That Met QC Criteria

November 6, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-RENAL-0901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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