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Carcinoma, Renal CellPhase 3NCT00073307

Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer

A Phase 3 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma, Renal Cell, run by Bayer at 121 sites in 19 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

The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
Sorafenib (Nexavar, BAY43-9006)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
903 participants
Where
121 sitesin 19 countries
Study dates
Nov 2003to Apr 2010
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with unresectable and/or metastatic, measurable renal cell carcinoma histologically or cytologically documented
  • Patients must have had one prior systemic therapy for advanced disease, which was completed at least 30 days but no longer than 8 months prior to randomization
  • Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST)
  • Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
  • Patients who have adequate coagulation, liver and kidney functions

Who cannot join

  • Patients with rare subtypes of renal cell carcinoma (RCC) such as pure papillary cell tumors, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors
  • Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma,or superficial bladder tumors, or other malignancies curatively treated > 2 years prior to entry
  • Cardiac arrhythmias requiring anti-arrhythmics, symptomatic coronary artery disease or ischemia or congestive heart failure
  • Patients with a history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
  • Patients with a history or presence of metastatic brain or meningeal tumors
  • Patients with seizure disorder requiring medication (such as anti-epileptics)
Show all 21Show fewer
  • History of organ allograft or bone marrow transplant of stem cell rescue
  • Patients who are pregnant or breast-feeding Women of childbearing potential must have a negative pregnancy test prior to drug administration. Both men and women enrolled in this trial must use adequate birth control
  • Patients who have three or more of the following:
  • ECOG performance status greater than or equal to 2,
  • Abnormally high lactate dehydrogenase,
  • Abnormally high serum hemoglobin,
  • Abnormally high corrected serum calcium,
  • Absence of prior nephrectomy
  • Excluded therapies and medications, previous and concomitant:
  • Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphonates
  • Significant surgery with 4 weeks of start of study
  • Investigational drug therapy during or within 30 days
  • Concomitant treatment with rifampin or St. John's Wort
  • Prior use of Raf-kinase inhibitors (RKI), MEK or Farnesyl transferase inhibitors
  • Prior use of Bevacizumab, and all other drugs (investigational or licensed) that target VEGF/VEGF receptors

Trial locations and contacts

121 sites in 19 countries.

121 sites in 19 countries

United States31 sites

  • Study site

    Atlanta, Georgia, 30309

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Brooklyn, New York, 11220

  • Study site

    Canton, Ohio, 44718

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Columbia, Missouri, 65203-3244

  • Study site

    Dallas, Texas, 75246

  • Study site

    Dayton, Ohio, 45429

  • Study site

    Frederick, Maryland, 21701

  • Study site

    Hamden, Connecticut, 06518

  • Study site

    Lafayette, Louisiana, 70506

  • Study site

    Laredo, Texas, 78041

  • Study site

    Los Angeles, California, 90033

  • Study site

    Los Angeles, California, 90057

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Milwaukee, Wisconsin, 53226-3596

  • Study site

    Minneapolis, Minnesota, 55455

  • Study site

    New York, New York, 10032

  • Study site

    Philadelphia, Pennsylvania, 19107-5096

  • Study site

    Portland, Oregon, 97239

  • Study site

    Richmond, Virginia, 23229

  • Study site

    Sacramento, California, 95817

  • Study site

    Salt Lake City, Utah, 84132

  • Study site

    San Antonio, Texas, 78212

  • Study site

    Seattle, Washington, 98101

  • Study site

    Spartanburg, South Carolina, 29303

  • Study site

    St Louis, Missouri, 63110-1093

  • Study site

    The Bronx, New York, 10466-2604

  • Study site

    Tucson, Arizona, 85712

Other trials in United States

France10 sites

  • Study site

    Bordeaux, 33000

  • Study site

    Caen, 14076

  • Study site

    Lille, 59020

  • Study site

    Lyon, 69008

  • Study site

    Marseille, 13273

  • Study site

    Nantes, 44805

  • Study site

    Paris, 75908

  • Study site

    Strasbourg, 67091

  • Study site

    Toulouse, 31052

  • Study site

    Villejuif, 94805

Other trials in France

Germany10 sites

  • Study site

    Berlin, State of Berlin, 10967

  • Study site

    Darmstadt, Hesse, 64276

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Study site

    Frankfurt am Main, Hesse, 60488

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • Study site

    Mannheim, Baden-Wurttemberg, 68167

  • Study site

    München, Bavaria, 81377

  • Study site

    Regensburg, Bavaria, 93042

  • Study site

    Ulm, Baden-Wurttemberg, 89075

Other trials in Germany

Poland9 sites

  • Study site

    Gdansk, 80-210

  • Study site

    Krakow, 31-115

  • Study site

    Lodz, 93-509

  • Study site

    Lublin, 20-090

  • Study site

    Poznan, 61-878

  • Study site

    Szczecin, 70-111

  • Study site

    Warsaw, 02-781

  • Study site

    Warsaw, 04-141

  • Study site

    Wroclaw, 50-043

Other trials in Poland

Russia7 sites

  • Study site

    Barnaul, 656049

  • Study site

    Kazan', 420029

  • Study site

    Kirov, 610021

  • Study site

    Moscow, 115478

  • Study site

    Moscow, 125284

  • Study site

    Obninsk, 249036

  • Study site

    Saint Petersburg, 198255

Other trials in Russia

United Kingdom7 sites

  • Study site

    Birmingham, West Midlands, B15 2TT

  • Study site

    Cardiff, South Glamorgan, CF14 2TL

  • Study site

    Glasgow, Stratchclyde, G11 6NT

  • Study site

    Manchester, Manchester, M20 4BX

  • Study site

    Newcastle upon Tyne, Tyne and Wear, NE4 6BE

  • Study site

    Northwood, Middlesex, HA6 2RN

  • Study site

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Australia6 sites

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    Garran, Australian Capital Territory, 2605

  • Study site

    Heidelberg, Victoria, 3084

  • Study site

    Liverpool, New South Wales, 2170

  • Study site

    Westmead, New South Wales, 2145

  • Study site

    Wodonga, Victoria, 0390

Other trials in Australia

Italy6 sites

  • Study site

    Milan, 20133

  • Study site

    Modena, 41124

  • Study site

    Pavia, 27100

  • Study site

    Perugia, 06122

  • Study site

    Reggio Emilia, 42100

  • Study site

    Roma, 00144

Other trials in Italy

Canada5 sites

  • Study site

    Edmonton, Alberta, T6G 1Z2

  • Study site

    Hamilton, Ontario, L8V 5C2

  • Study site

    London, Ontario, N6A 4L6

  • Study site

    Montreal, Quebec, H3T 1E2

  • Study site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Ukraine5 sites

  • Study site

    Donetsk, 83092

  • Study site

    Kharkiv, 61024

  • Study site

    Kiev, 115

  • Study site

    Lviv, 79031

  • Study site

    Poltava, 36024

Other trials in Ukraine

Argentina4 sites

  • Study site

    Capital Federal-Buenos Aires, C1426ANZ

  • Study site

    Mendoza, 5500

  • Study site

    Rosario, Santa Fe Province, S2000DSK

  • Study site

    Santa Fe, Santa Fe Province, S3000FFV

Other trials in Argentina

Hungary4 sites

  • Study site

    Budapest, 1032

  • Study site

    Budapest, 1121

  • Study site

    Debrecen, 4004

  • Study site

    Zalaegerszeg, 8900

Other trials in Hungary

South Africa4 sites

  • Study site

    Bloemfontein, Freestate, 9300

  • Study site

    Cape Town, Western Cape, 7500

  • Study site

    Durban, KwaZulu-Natal, 4001

  • Study site

    Pretoria, Gauteng

Other trials in South Africa

Spain4 sites

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Cruces/Barakaldo, Bilbao, 48903

  • Study site

    Madrid, Madrid, 28040

  • Study site

    Valencia, Valencia, 46009

Other trials in Spain

Brazil3 sites

  • Study site

    Curitiba, Paraná, 81520-060

  • Study site

    Porto Alegre, Rio Grande do Sul, 90020-060

  • Study site

    Porto Alegre, Rio Grande do Sul, 90619900

Other trials in Brazil

Belgium2 sites

  • Study site

    Bruxelles - Brussel, 1000

  • Study site

    Bruxelles - Brussel, 1090

Other trials in Belgium

Israel2 sites

  • Study site

    Haifa, 3109601

  • Study site

    Tel Aviv, 64239

Other trials in Israel

Chile1 site

  • Study site

    Santiago

Other trials in Chile

Netherlands1 site

  • Study site

    Nijmegen, 6525 GA

Other trials in Netherlands

About this study

Official title: A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.

The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.

Read the detailed description

Overall Survival (OS), Patient-reported outcome (PRO)

Being tested
Sorafenib (Nexavar, BAY43-9006), Placebo
Keywords
Renal Cell Cancer (RCC), Cancer
Medical subject headings
Carcinoma, Renal Cell, Neoplasms

What participants receive

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

  • Sorafenib (Nexavar, BAY43-9006)Drug

    Multi Kinase Inhibitor

  • PlaceboDrug

    Placebo

Study groups in NCT00073307
Study groupRoleWhat they receive
Sorafenib (Nexavar, BAY43-9006)ExperimentalSorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
Receives: Drug: Sorafenib (Nexavar, BAY43-9006)
PlaceboPlacebo comparatorPlacebo tablets matching in appearance were to be orally administered twice a day.
Receives: Drug: Placebo

What is being measured

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

  1. Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population

    Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.

    Measured: From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later

  2. Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population

    Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.

    Measured: From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later

Secondary outcomes (4)

  1. Final Progression-Free Survival (PFS) - Independent Radiological Review

    PFS determined as the time (days) from the date of randomization at start of study to the actual date of disease progression (PD) (radiological or clinical) or death due to any cause, if death occurred before PD. Outcome measure was assessed approximately every 8 weeks using RECIST v1.0 criteria by independent radiologic review. Radiological PD defined as at least 20% increase in sum of longest diameter (LD) of measured lesions taking as reference smallest sum LD recorded since treatment started or appearance of new lesions.

    Measured: From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.

  2. Best Overall Response - Independent Radiological Review

    Best overall response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 by independent radiologic review. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased) and not evaluated.

    Measured: From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.

  3. Health-related Quality of Life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) Assessment

    Primary Analysis for FKSI-10 patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FKSI-10 patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the range of values for FKSI-10 total score is from 0 to 40; higher score represents better HRQOL.

    Measured: From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.

  4. Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment

    Primary Analysis for FACT-G (using PWB score) patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FACT-G (PWB score) patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the total FACT-G (PWB score) range of values is from 0 to 28; higher score represents better HRQOL.

    Measured: From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.

Timeline

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

  1. First posted21 Nov 2003 (estimated)
  2. Study startNov 2003
  3. Primary completionSep 2006
  4. Study completionApr 2010

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
903 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00073307
Sponsor's protocol ID
11213
Status last verified
Jan 2014
First submitted
19 Nov 2003
Last updated
6 Feb 2014
Data monitoring committee
Yes

Publications

  • Antoun S, Birdsell L, Sawyer MB, Venner P, Escudier B, Baracos VE. Association of skeletal muscle wasting with treatment with sorafenib in patients with advanced renal cell carcinoma: results from a placebo-controlled study. J Clin Oncol. 2010 Feb 20;28(6):1054-60. doi: 10.1200/JCO.2009.24.9730. Epub 2010 Jan 19.

    PubMed 20085939

  • Bellmunt J, Eisen T, Fishman M, Quinn D. Experience with sorafenib and adverse event management. Crit Rev Oncol Hematol. 2011 Apr;78(1):24-32. doi: 10.1016/j.critrevonc.2010.03.006. Epub 2010 Apr 18.

    PubMed 20399677

  • Massard C, Zonierek J, Gross-Goupil M, Fizazi K, Szczylik C, Escudier B. Incidence of brain metastases in renal cell carcinoma treated with sorafenib. Ann Oncol. 2010 May;21(5):1027-31. doi: 10.1093/annonc/mdp411. Epub 2009 Oct 22.

    PubMed 19850637

  • Negrier S, Jager E, Porta C, McDermott D, Moore M, Bellmunt J, Anderson S, Cihon F, Lewis J, Escudier B, Bukowski R. Efficacy and safety of sorafenib in patients with advanced renal cell carcinoma with and without prior cytokine therapy, a subanalysis of TARGET. Med Oncol. 2010 Sep;27(3):899-906. doi: 10.1007/s12032-009-9303-z. Epub 2009 Sep 12.

    PubMed 19757215

  • Pena C, Lathia C, Shan M, Escudier B, Bukowski RM. Biomarkers predicting outcome in patients with advanced renal cell carcinoma: Results from sorafenib phase III Treatment Approaches in Renal Cancer Global Evaluation Trial. Clin Cancer Res. 2010 Oct 1;16(19):4853-63. doi: 10.1158/1078-0432.CCR-09-3343. Epub 2010 Jul 22.

    PubMed 20651059

  • Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Staehler M, Negrier S, Chevreau C, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Anderson S, Hofilena G, Shan M, Pena C, Lathia C, Bukowski RM. Sorafenib for treatment of renal cell carcinoma: Final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol. 2009 Jul 10;27(20):3312-8. doi: 10.1200/JCO.2008.19.5511. Epub 2009 May 18.

    PubMed 19451442

  • Eisen T, Oudard S, Szczylik C, Gravis G, Heinzer H, Middleton R, Cihon F, Anderson S, Shah S, Bukowski R, Escudier B; TARGET Study Group. Sorafenib for older patients with renal cell carcinoma: subset analysis from a randomized trial. J Natl Cancer Inst. 2008 Oct 15;100(20):1454-63. doi: 10.1093/jnci/djn319. Epub 2008 Oct 7.

    PubMed 18840822

  • Bukowski R, Cella D, Gondek K, Escudier B; Sorafenib TARGETs Clinical Trial Group. Effects of sorafenib on symptoms and quality of life: results from a large randomized placebo-controlled study in renal cancer. Am J Clin Oncol. 2007 Jun;30(3):220-7. doi: 10.1097/01.coc.0000258732.80710.05.

    PubMed 17551296

  • Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34. doi: 10.1056/NEJMoa060655.

    PubMed 17215530

  • Kane RC, Farrell AT, Saber H, Tang S, Williams G, Jee JM, Liang C, Booth B, Chidambaram N, Morse D, Sridhara R, Garvey P, Justice R, Pazdur R. Sorafenib for the treatment of advanced renal cell carcinoma. Clin Cancer Res. 2006 Dec 15;12(24):7271-8. doi: 10.1158/1078-0432.CCR-06-1249.

    PubMed 17189398

  • Lamuraglia M, Escudier B, Chami L, Schwartz B, Leclere J, Roche A, Lassau N. To predict progression-free survival and overall survival in metastatic renal cancer treated with sorafenib: pilot study using dynamic contrast-enhanced Doppler ultrasound. Eur J Cancer. 2006 Oct;42(15):2472-9. doi: 10.1016/j.ejca.2006.04.023. Epub 2006 Sep 11.

    PubMed 16965911

  • Quintanilha JCF, Geyer S, Etheridge AS, Racioppi A, Hammond K, Crona DJ, Pena CE, Jacobson SB, Marmorino F, Rossini D, Cremolini C, Sanoff HK, Abou-Alfa GK, Innocenti F. KDR genetic predictor of toxicities induced by sorafenib and regorafenib. Pharmacogenomics J. 2022 Dec;22(5-6):251-257. doi: 10.1038/s41397-022-00279-3. Epub 2022 Apr 28.

    PubMed 35484400

  • Quintanilha JCF, Racioppi A, Wang J, Etheridge AS, Denning S, Pena CE, Skol AD, Crona DJ, Lin D, Innocenti F. PIK3R5 genetic predictors of hypertension induced by VEGF-pathway inhibitors. Pharmacogenomics J. 2022 Feb;22(1):82-88. doi: 10.1038/s41397-021-00261-5. Epub 2021 Nov 13.

    PubMed 34775477

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma, Renal Cell, run by Bayer at 121 sites in 19 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 5 inclusion and 21 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 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in United States, France, Germany, Poland, Russia and 14 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 14 Dec 2011). 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?

Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population (time frame: From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later). The study lists 2 primary outcomes in all. 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 NCT00073307, which also lists 13 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 6 Feb 2014.

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