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Metastatic Renal Cell CarcinomaPhase 3RECORD-1NCT00410124

RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed After Treatment With Sorafenib and/or Sunitinib

A Phase 3 study testing RAD001 in people with Metastatic Renal Cell Carcinoma, run by Novartis Pharmaceuticals at 93 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To assess whether daily treatment with RAD001 could slow the growth and spread of metastatic carcinoma of the kidney. The safety of RAD001 was also to be studied in this trial. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Metastatic Renal Cell Carcinoma
What is being tested?
RAD001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
416 participants
Where
93 sitesin 10 countries
Study dates
Nov 2006to Oct 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with metastatic carcinoma and with histological or cytological confirmation of clear cell RCC (tissue from the original diagnosis of renal cell cancer is acceptable).
  • The date of progression on sunitinib and/or sorafenib must be within 6 months.
  • Patients may have received one or both agents
  • Prior therapy with cytokines (i.e., IL-2, Interferon) and/or VEGF-ligand inhibitors (i.e., bevacizumab) are permitted.
  • Prior vaccine therapy in the adjuvant setting is permitted.
  • Patients with at least one measurable lesion at baseline as per the Response evaluation criteria in solid tumors (RECIST) criteria, either on physical exam or as determined by Computer Tomography (CT) Scan or Magnetic Resonance Imaging (MRI).
Show all 11Show fewer
  • Patients with a Karnofsky Performance Status ≥70%.
  • Adequate bone marrow, liver and renal function.
  • Patients with a life expectancy ≥ 3 months.
  • Women of childbearing potential must have had a negative serum or urine pregnancy test 48 hours prior to the administration of the first study treatment.
  • Patients who give a written informed consent obtained according to local guidelines

Who cannot join

  • Patients currently receiving chemotherapy, immunotherapy, or radio-therapy or who have received these within 4 weeks of study entry
  • Patients who have previously received mTOR inhibitors.
  • Patients with a known hypersensitivity to RAD001 or other rapamycins (sirolimus, temsirolimus) or to its excipients.
  • Patients with untreated CNS metastases or who are neurologically unstable despite treatment of the CNS metastases. (Patients with treated CNS metastases, who are neurologically stable off of corticosteroids, are eligible to enter study).
  • Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent
  • Patients with a known history of HIV seropositivity.
Show all 13Show fewer
  • Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin)
  • Patients who have any severe and/or uncontrolled medical conditions
  • Patients who have a history of another primary malignancy ≤ 3 years, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
  • Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes.
  • Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to randomization
  • Patients unwilling to or unable to comply with the protocol
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

93 sites in 10 countries.

93 sites in 10 countries

United States31 sites

  • Novartis Investigative Site

    Baltimore, Maryland, 21201

  • Novartis Investigative Site

    Bedford, Texas, 76022

  • Novartis Investigative Site

    Buffalo, New York, 14263

  • Novartis Investigative Site

    Canton, Ohio, 44718

  • Novartis Investigative Site

    Chapel Hill, North Carolina, 27599

  • Novartis Investigative Site

    Columbia, Missouri, 65201

  • Novartis Investigative Site

    Dallas, Texas, 75246

  • Novartis Investigative Site

    Detroit, Michigan, 48201

  • Novartis Investigative Site

    Duarte, California, 91010-3000

  • Novartis Investigative Site

    Durham, North Carolina, 27710

  • Novartis Investigative Site

    Fayetteville, Arkansas, 72703

  • Novartis Investigative Site

    Indianapolis, Indiana, 46202

  • Novartis Investigative Site

    Indianapolis, Indiana, 46227

  • Novartis Investigative Site

    Las Vegas, Nevada, 89135

  • Novartis Investigative Site

    Louisville, Kentucky, 40202

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55455

  • Novartis Investigative Site

    Morgantown, West Virginia, 26506

  • Novartis Investigative Site

    New York, New York, 10021

  • Novartis Investigative Site

    Ocoee, Florida, *see dep*

  • Novartis Investigative Site

    Orlando, Florida, 32806

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15232

  • Novartis Investigative Site

    Portland, Oregon, 97210

  • Novartis Investigative Site

    Raleigh, North Carolina, 27609

  • Novartis Investigative Site

    Sacramento, California, 95817

  • Novartis Investigative Site

    San Antonio, Texas, 78229

  • Novartis Investigative Site

    San Francisco, California, 94115

  • Novartis Investigative Site

    Santa Monica, California, 90404

  • Novartis Investigative Site

    Seattle, Washington, 98109-1023

  • Novartis Investigative Site

    Spokane, Washington, 99202

  • Novartis Investigative Site

    St Louis, Missouri, 63110

  • Novartis Investigative Site

    Tyler, Texas, 75702

Other trials in United States

Japan14 sites

  • Novartis Investigative Site

    Akita, Akita, 010-8543

  • Novartis Investigative Site

    Chiba, Chiba, 260-8717

  • Novartis Investigative Site

    Chuo-ku, Tokyo, 104-0045

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 812-8582

  • Novartis Investigative Site

    Kurashiki, Okayama-ken, 710-8602

  • Novartis Investigative Site

    Matsuyama, Ehime, 791-0280

  • Novartis Investigative Site

    Osaka, Osaka, 537-8511

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8543

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8648

  • Novartis Investigative Site

    Sayama, Osaka, 589-8511

  • Novartis Investigative Site

    Sunto-gun, Shizuoka, 411-8777

  • Novartis Investigative Site

    Tokushima, Tokushima, 770-8503

  • Novartis Investigative Site

    Tsukuba, Ibaraki, 305-8576

  • Novartis Investigative Site

    Utsunomiya, Tochigi, 320-0834

Other trials in Japan

France8 sites

  • Novartis Investigative Site

    Bordeaux, 33075

  • Novartis Investigative Site

    Lille, 59020

  • Novartis Investigative Site

    Lyon, 69373

  • Novartis Investigative Site

    Paris, 75015

  • Novartis Investigative Site

    Saint-Herblain Cédex, 44805

  • Novartis Investigative Site

    Strasbourg, 67091

  • Novartis Investigative Site

    Toulouse, 31052

  • Novartis Investigative Site

    Villejuif, 94805

Other trials in France

Italy8 sites

  • Novartis Investigative Site

    Cremona, CR, 26100

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    Milan, MI, 20133

  • Novartis Investigative Site

    Modena, MO, 41100

  • Novartis Investigative Site

    Naples, 80132

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Perugia, PG, 06129

  • Novartis Investigative Site

    Roma, RM, 00152

Other trials in Italy

Canada7 sites

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 1Z2

  • Novartis Investigative Site

    Hamilton, Ontario, L8V 5C2

  • Novartis Investigative Site

    London, Ontario, N6A 4G5

  • Novartis Investigative Site

    Montreal, Quebec, H3G 1A4

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9

  • Novartis Investigative Site

    Vancouver, Alberta, V5Z 4E6

Other trials in Canada

Australia6 sites

  • Novartis Investigative Site

    Camperdown, New South Wales, 2050

  • Novartis Investigative Site

    Heidelberg, Victoria, 3084

  • Novartis Investigative Site

    Randwick, New South Wales, 2031

  • Novartis Investigative Site

    South Brisbane, Queensland, 4101

  • Novartis Investigative Site

    Westmead, New South Wales, 2145

  • Novartis Investigative Site

    Woodville, South Australia, 5011

Other trials in Australia

Germany6 sites

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Frankfurt/M, 60590

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Kassel, 34125

  • Novartis Investigative Site

    Mainz, 55101

  • Novartis Investigative Site

    München, 81675

Other trials in Germany

Spain5 sites

  • Novartis Investigative Site

    Barcelona, Barcelona, 08035

  • Novartis Investigative Site

    Barcelona, Spain, 08025

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Valencia, 46009

Other trials in Spain

Netherlands4 sites

  • Novartis Investigative Site

    Amsterdam

  • Novartis Investigative Site

    Leiden, 2300 RC

  • Novartis Investigative Site

    Nijmegen, 6525 GA

  • Novartis Investigative Site

    Utrecht, Netherlands, 3584CX

Other trials in Netherlands

Poland4 sites

  • Novartis Investigative Site

    Gdañsk, 80-219

  • Novartis Investigative Site

    Lodz, 90-153

  • Novartis Investigative Site

    Warsaw, 00-909

  • Novartis Investigative Site

    Wroclaw, 50-367

Other trials in Poland

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Compare the Safety and Efficacy of RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed on VEGF Receptor Tyrosine Kinase Inhibitor

To assess whether daily treatment with RAD001 could slow the growth and spread of metastatic carcinoma of the kidney. The safety of RAD001 was also to be studied in this trial.

Being tested
RAD001, Placebo
Keywords
advanced kidney cancer, everolimus, kidney cancer, oral therapy
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RAD001Drug

    Also called Everolimus

    The dose of RAD001 was 10 mg/day. Patients were instructed to take two tablets (5 mg each) by mouth every day.

  • PlaceboDrug

Study groups in NCT00410124
Study groupRoleWhat they receive
RAD001 +BSCExperimentalThe study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
Receives: Drug: RAD001
Placebo (plus BSC)Placebo comparatorPatients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progressive Free Survival (PFS) in Patients Who Receive RAD001 Plus Best Supportive Care(BSC) Versus Patients Who Receive Matching Placebo Plus BSC

    Progression Free survival is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary statistical analysis of PFS was based on central radiological assessments using a one-sided stratified log-rank test. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study. Kaplan-Meier methodology was used to estimate the median PFS for each treatment group.

    Measured: Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported between date of first patient randomized until 28Feb2008 cut of date.

Secondary outcomes (12)

  1. Overall Survival (OS) Assessed by the Monthly Overall Survival Assessments

    Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group

    Measured: Assessed every month up to 2 years after the last patient was randomized into the study from the date of randomization to the time of death. (Data cutoff was 15Nov2009)

  2. Best Overall Response Rate in Patients Who Receive RAD001 Plus BSC Versus Matching Placebo Plus BSC

    The Best Overall Response rate (BOR) is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study.

    Measured: Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported, between date of first patient randomized until 28Feb2008 cutoff date

  3. Duration of Response in Patients Who Receive RAD001 Plus BSC Versus Placebo Plus BSC

    Duration of overall response (CR or PR) applies only to patients whose Best Overall Response (BOR) was Complete Response (CR) or Partial Response (PR). The start date is the date of first documented response (CR or PR) and the end date is the date of event defined as the first documented progression or death. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study.

    Measured: Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported, between date of first patient randomized until 28Feb2008 cutoff date

  4. Analysis of Time to Definitive Deterioration of the Global Health Status/QoL Scale(QL) Scores of the EORTC QLQ-30 Questionnaire by at Least 10 Percent Using Kaplan Meier Method, by Treatment.

    The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. Global health status / QoL scale (QL), consisting of 2 questions each scored from 1 (very poor) to 7 (excellent), and with possible scores ranging from 2 to 14. Higher score indicates better functioning. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and date of assessment at which definitive deterioration is seen.

    Measured: Baseline and every 28 days under treatment and at discontinuation from RAD001" until 28Feb2008 cutoff date

  5. Time to Definitive Deterioration of the FKS-DRS Risk Score by at Least 2 Score Units Using Kaplan-Meier Method, by Treatment.

    The Functional Assessment of Cancer Therapy - Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) is a set of items to assess symptoms experienced by patients with advanced kidney cancer. These symptoms include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. There were 4 response categories (1=Not at all, 2= A little, 3=Quite a bit, 4=Very much), sum of item responses can range from 0 to 36. "0"= severely symptomatic patient and the highest score is an asymptomatic patient. Definitive deterioration of the FKSI-DRS score was defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen.

    Measured: Baseline and every 28 days under treatment and at discontinuation from RAD001" until 28Feb2008 cutoff date

  6. Time to Definitive Deterioration of the Physical Functioning Scale (PF)Score of the EORTC QLQ-C30 Questionnaire by at Least 10 Percent Using Kaplan_Meier Method, by Treatment.

    The EORTC QLQ-C30 contains 30 items. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Physical Functioning (PF) sub-scale, consisting of 5 questions each scored from 1 (not at all) to 4 (very much), and with possible values ranging from 5 to 20. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen.

    Measured: Baseline and every 28 days under treatment and at discontinuation from RAD001" until 28Feb2008 cutoff date

  7. Pharmacokinetics of RAD001:Peak Concentration in a Dosing Interval (C-max); Pre-dose Concentration at 24-h Time Point in Dosing Interval (C-min) and Average Concentration in a Dosing Interval =(C-avg)

    Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol. C-avg= Area under curve (AUC) in a dosing interval from time-zero to time of the last quantifiable concentration (AUC0-tlast)/ time of the last quantifiable concentration in a dosing interval (tlast)

    Measured: At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day1, Cycle 1 Day 15 and at pre-dose from Cycle 2(day1) and all subsequent treatment cycles up until data cut-off 28 Feb 2008.

  8. Pharmacokinetics of RAD001: Time at Which C-Max Occurs (t-Max)

    Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.

    Measured: At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose of From Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.

  9. Pharmacokinetics of RAD001: Area Under Curve (AUC) in a Dosing Interval From Time-zero to Time of the Last Quantifiable Concentration. (AUC 0-tlast)

    Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.

    Measured: At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.

  10. Pharmacokinetics of RAD001: Time of the Last Quantifiable Concentration in a Dosing Interval - (Tlast)

    Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.

    Measured: At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.

  11. Pharmacokinetics of RAD001: Apparent Systemic Clearance From Blood Following Extravascular Administration (CL/F)

    Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.Apparent oral clearance of RAD001 (CL/F) was calculated using AUC in a dosing interval of 24 hours (AUC0-24hours) value on Day 15 as: CL/F = dose/ AUC0-τ

    Measured: At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.

  12. Pharmacokinetics of RAD001: Normalized to Body Surface Area (CL/F)

    Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.

    Measured: At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionFeb 2008
  4. Study completionOct 2011

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
416 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00410124
Sponsor's protocol ID
CRAD001C2240
Other IDs
2006-002070-21
Acronym
RECORD-1
Status last verified
Dec 2012
First submitted
11 Dec 2006
Last updated
15 Jan 2013

Publications

  • Stein A, Bellmunt J, Escudier B, Kim D, Stergiopoulos SG, Mietlowski W, Motzer RJ; RECORD-1 Trial Study Group. Survival prediction in everolimus-treated patients with metastatic renal cell carcinoma incorporating tumor burden response in the RECORD-1 trial. Eur Urol. 2013 Dec;64(6):994-1002. doi: 10.1016/j.eururo.2012.11.032. Epub 2012 Nov 21.

    PubMed 23219086

  • Stein A, Wang W, Carter AA, Chiparus O, Hollaender N, Kim H, Motzer RJ, Sarr C. Dynamic tumor modeling of the dose-response relationship for everolimus in metastatic renal cell carcinoma using data from the phase 3 RECORD-1 trial. BMC Cancer. 2012 Jul 23;12:311. doi: 10.1186/1471-2407-12-311.

    PubMed 22824201

  • Oudard S, Thiam R, Fournier LS, Medioni J, Lamuraglia M, Scotte F, Fabre E, Kim D, Kpamegan E, Panneerselvam A, Cuenod CA. Optimisation of the tumour response threshold in patients treated with everolimus for metastatic renal cell carcinoma: analysis of response and progression-free survival in the RECORD-1 study. Eur J Cancer. 2012 Jul;48(10):1512-8. doi: 10.1016/j.ejca.2012.01.027. Epub 2012 Feb 16.

    PubMed 22342553

  • Porta C, Calvo E, Climent MA, Vaishampayan U, Osanto S, Ravaud A, Bracarda S, Hutson TE, Escudier B, Grunwald V, Kim D, Panneerselvam A, Anak O, Motzer RJ. Efficacy and safety of everolimus in elderly patients with metastatic renal cell carcinoma: an exploratory analysis of the outcomes of elderly patients in the RECORD-1 Trial. Eur Urol. 2012 Apr;61(4):826-33. doi: 10.1016/j.eururo.2011.12.057. Epub 2012 Jan 5.

    PubMed 22297244

  • Calvo E, Escudier B, Motzer RJ, Oudard S, Hutson TE, Porta C, Bracarda S, Grunwald V, Thompson JA, Ravaud A, Kim D, Panneerselvam A, Anak O, Figlin RA. Everolimus in metastatic renal cell carcinoma: Subgroup analysis of patients with 1 or 2 previous vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapies enrolled in the phase III RECORD-1 study. Eur J Cancer. 2012 Feb;48(3):333-9. doi: 10.1016/j.ejca.2011.11.027. Epub 2011 Dec 30.

    PubMed 22209391

  • White DA, Camus P, Endo M, Escudier B, Calvo E, Akaza H, Uemura H, Kpamegan E, Kay A, Robson M, Ravaud A, Motzer RJ. Noninfectious pneumonitis after everolimus therapy for advanced renal cell carcinoma. Am J Respir Crit Care Med. 2010 Aug 1;182(3):396-403. doi: 10.1164/rccm.200911-1720OC. Epub 2010 Mar 1.

    PubMed 20194812

  • Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, Grunwald V, Thompson JA, Figlin RA, Hollaender N, Urbanowitz G, Berg WJ, Kay A, Lebwohl D, Ravaud A; RECORD-1 Study Group. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet. 2008 Aug 9;372(9637):449-56. doi: 10.1016/S0140-6736(08)61039-9. Epub 2008 Jul 22.

    PubMed 18653228

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RAD001 in people with Metastatic Renal Cell Carcinoma, run by Novartis Pharmaceuticals at 93 sites in 10 countries.

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 11 inclusion and 13 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 15 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States, Japan, France, Italy, Canada and 5 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progressive Free Survival (PFS) in Patients Who Receive RAD001 Plus Best Supportive Care(BSC) Versus Patients Who Receive Matching Placebo Plus BSC (time frame: Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported between date of first patient randomized until 28Feb2008 cut of date.). 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 NCT00410124, which also lists 7 linked publications.

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 15 Jan 2013.

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