Renal Cell CarcinomaPhase 2NCT00830895
RAD001 for Non-clear Cell Renal Cell Carcinoma (RCC)
A Phase 2 study testing RAD001 in people with Renal Cell Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To assess the efficacy and safety of RAD001 (everolimus) in non-clear cell renal cell carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- RAD001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Renal Cell Carcinoma
- Being tested
- RAD001
- Keywords
- Renal cell carcinoma, Non-clear cell, RAD001, Metastatic, non-clear cell, renal cell carcinoma
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD001Drug
RAD001 10mg/day
| Study group | Role | What they receive |
|---|---|---|
| RAD001 | Experimental | RAD001 10mg/day Receives: Drug: RAD001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
It is the time from treatment initiation until disease progression.
Measured: 2 months, 4 months, 6 months
Secondary outcomes (5)
Response rate
It is the percentage of patients whose cancer shrinks or disappears after treatment.
Measured: 2 months, 4 months, 6 months
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.
Measured: 2 months, 4 months, 6 months
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.
Measured: 2 months, 4 months, 6 months
Metabolic response rate by FDG-PET
It is assesed target lesions and non- target lesions by FDG-PET.
Measured: 2 months, 4 months, 6 months
Safety
Measured: monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2010
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Se-Hoon Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830895
- Sponsor's protocol ID
- SNUH-RENAL-0901
- Status last verified
- Nov 2022
- First submitted
- 27 Jan 2009
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23180114
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Efficacy of RAD001 in Metastatic Non-clear Cell Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00830895
- Acronym / sponsor ID
- SNUH-RENAL-0901
- Conditions
- Renal Cell Carcinoma
- Keywords
- Renal cell carcinoma, Non-clear cell, RAD001, Metastatic, non-clear cell, renal cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy and safety of RAD001 (everolimus) in non-clear cell renal cell carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAD001 | Experimental | Drug: RAD001RAD001 10mg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAD001RAD001 10mg/day | Drug | RAD001 |
Primary outcome
Progression-free survival
Time frame: 2 months, 4 months, 6 months
It is the time from treatment initiation until disease progression.
5 secondary outcomes
Response rate
Time frame: 2 months, 4 months, 6 months
Disease-control rate
Time frame: 2 months, 4 months, 6 months
Overall survival
Time frame: 2 months, 4 months, 6 months
Metabolic response rate by FDG-PET
Time frame: 2 months, 4 months, 6 months
Safety
Time frame: monthly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Derived from this study: PubMed 23180114Koh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RAD001 in people with Renal Cell Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 2 months, 4 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00830895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.