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

8 januari 2014 uppdaterad av: Bayer

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Faktisk)

903

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Argentina
      • Capital Federal-Buenos Aires, Argentina, C1426ANZ
      • Mendoza, Argentina, 5500
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DSK
      • Santa Fé, Santa Fe, Argentina, S3000FFV
  • Australien
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australien, 2605
    • New South Wales
      • Camperdown, New South Wales, Australien, 2050
      • Liverpool, New South Wales, Australien, 2170
      • Westmead, New South Wales, Australien, 2145
    • Victoria
      • Heidelberg, Victoria, Australien, 3084
      • Wodonga, Victoria, Australien, 0390
  • Belgien
      • Bruxelles - Brussel, Belgien, 1000
      • Bruxelles - Brussel, Belgien, 1090
  • Brasilien
    • Parana
      • Curitiba, Parana, Brasilien, 81520-060
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90619900
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90020-060
  • Chile
      • Santiago de Chile, Chile
  • Frankrike
      • Bordeaux, Frankrike, 33000
      • Caen Cedex 5, Frankrike, 14076
      • Lille Cedex, Frankrike, 59020
      • Lyon Cedex, Frankrike, 69008
      • Marseille, Frankrike, 13273
      • Nantes, Frankrike, 44805
      • Paris Cedex 15, Frankrike, 75908
      • Strasbourg, Frankrike, 67091
      • Toulouse, Frankrike, 31052
      • Villejuif, Frankrike, 94805
  • Förenta staterna
    • Arizona
      • Tucson, Arizona, Förenta staterna, 85712
    • California
      • Los Angeles, California, Förenta staterna, 90033
      • Los Angeles, California, Förenta staterna, 90057
      • Sacramento, California, Förenta staterna, 95817
    • Colorado
      • Aurora, Colorado, Förenta staterna, 80045
    • Connecticut
      • Hamden, Connecticut, Förenta staterna, 06518
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30309
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60637
    • Kentucky
      • Louisville, Kentucky, Förenta staterna, 40202
    • Louisiana
      • Lafayette, Louisiana, Förenta staterna, 70506
    • Maryland
      • Frederick, Maryland, Förenta staterna, 21701
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02215
    • Minnesota
      • Minneapolis, Minnesota, Förenta staterna, 55455
    • Missouri
      • Columbia, Missouri, Förenta staterna, 65203-3244
      • St. Louis, Missouri, Förenta staterna, 63110-1093
    • New York
      • Bronx, New York, Förenta staterna, 10466-2604
      • Brooklyn, New York, Förenta staterna, 11220
      • New York, New York, Förenta staterna, 10032
    • Ohio
      • Canton, Ohio, Förenta staterna, 44718
      • Cleveland, Ohio, Förenta staterna, 44195
      • Dayton, Ohio, Förenta staterna, 45429
    • Oregon
      • Portland, Oregon, Förenta staterna, 97239
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19107-5096
    • South Carolina
      • Spartanburg, South Carolina, Förenta staterna, 29303
    • Texas
      • Dallas, Texas, Förenta staterna, 75246
      • Laredo, Texas, Förenta staterna, 78041
      • San Antonio, Texas, Förenta staterna, 78212
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84132
    • Virginia
      • Richmond, Virginia, Förenta staterna, 23229
    • Washington
      • Seattle, Washington, Förenta staterna, 98101
    • Wisconsin
      • Milwaukee, Wisconsin, Förenta staterna, 53226-3596
  • Israel
      • Haifa, Israel, 3109601
      • Tel Aviv, Israel, 64239
  • Italien
      • Milano, Italien, 20133
      • Modena, Italien, 41124
      • Pavia, Italien, 27100
      • Perugia, Italien, 06122
      • Reggio Emilia, Italien, 42100
      • Roma, Italien, 00144
  • Kanada
    • Alberta
      • Edmonton, Alberta, Kanada, T6G 1Z2
    • Ontario
      • Hamilton, Ontario, Kanada, L8V 5C2
      • London, Ontario, Kanada, N6A 4L6
      • Toronto, Ontario, Kanada, M5G 2M9
    • Quebec
      • Montreal, Quebec, Kanada, H3T 1E2
  • Nederländerna
      • Nijmegen, Nederländerna, 6525 GA
  • Polen
      • Gdansk, Polen, 80-210
      • Krakow, Polen, 31-115
      • Lodz, Polen, 93-509
      • Lublin, Polen, 20-090
      • Poznan, Polen, 61-878
      • Szczecin, Polen, 70-111
      • Warszawa, Polen, 02-781
      • Warszawa, Polen, 04-141
      • Wroclaw, Polen, 50-043
  • Ryska Federationen
      • Barnaul, Ryska Federationen, 656049
      • Kazan, Ryska Federationen, 420029
      • Kirov, Ryska Federationen, 610021
      • Moscow, Ryska Federationen, 125284
      • Moscow, Ryska Federationen, 115478
      • Obninsk, Ryska Federationen, 249036
      • St. Petersburg, Ryska Federationen, 198255
  • Spanien
      • Barcelona, Spanien, 08035
      • Madrid, Spanien, 28040
      • Valencia, Spanien, 46009
    • Bilbao
      • Cruces/Barakaldo, Bilbao, Spanien, 48903
  • Storbritannien
      • Manchester, Storbritannien, M20 4BX
    • Middlesex
      • Northwood, Middlesex, Storbritannien, HA6 2RN
    • South Glamorgan
      • Cardiff, South Glamorgan, Storbritannien, CF14 2TL
    • Stratchclyde
      • Glasgow, Stratchclyde, Storbritannien, G11 6NT
    • Surrey
      • Sutton, Surrey, Storbritannien, SM2 5PT
    • Tyne and Wear
      • Newcastle Upon Tyne, Tyne and Wear, Storbritannien, NE4 6BE
    • West Midlands
      • Birmingham, West Midlands, Storbritannien, B15 2TT
  • Sydafrika
    • Freestate
      • Bloemfontein, Freestate, Sydafrika, 9300
    • Gauteng
      • Pretoria, Gauteng, Sydafrika
    • Kwazulu-Natal
      • Durban, Kwazulu-Natal, Sydafrika, 4001
    • Western Cape
      • Cape Town, Western Cape, Sydafrika, 7500
  • Tyskland
      • Berlin, Tyskland, 10967
      • Hamburg, Tyskland, 20246
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Tyskland, 68167
      • Ulm, Baden-Württemberg, Tyskland, 89075
    • Bayern
      • München, Bayern, Tyskland, 81377
      • Regensburg, Bayern, Tyskland, 93042
    • Hessen
      • Darmstadt, Hessen, Tyskland, 64276
      • Frankfurt, Hessen, Tyskland, 60488
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Tyskland, 40225
    • Sachsen
      • Dresden, Sachsen, Tyskland, 01307
  • Ukraina
      • Donetsk, Ukraina, 83092
      • Kharkiv, Ukraina, 61024
      • Kiev, Ukraina, 115
      • Lviv, Ukraina, 79031
      • Poltava, Ukraina, 36024
  • Ungern
      • Budapest, Ungern, 1121
      • Budapest, Ungern, 1032
      • Debrecen, Ungern, 4004
      • Zalaegerszeg, Ungern, 8900

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Sorafenib (Nexavar, BAY43-9006)
Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
Läkemedel: Sorafenib (Nexavar, BAY43-9006)
Multi Kinase Inhibitor
Placebo-jämförare: Placebo
Placebo tablets matching in appearance were to be orally administered twice a day.
Läkemedel: Placebo
Placebo

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population
Tidsram: From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
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.
From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population
Tidsram: From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
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.
From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Final Progression-Free Survival (PFS) - Independent Radiological Review
Tidsram: From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
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.
From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
Best Overall Response - Independent Radiological Review
Tidsram: From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
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.
From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
Health-related Quality of Life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) Assessment
Tidsram: 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.
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.
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.
Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment
Tidsram: 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.
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.
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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Bayer

Samarbetspartners

Amgen

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2003

Primärt slutförande (Faktisk)

1 september 2006

Avslutad studie (Faktisk)

1 april 2010

Studieregistreringsdatum

Först inskickad

19 november 2003

Först inskickad som uppfyllde QC-kriterierna

20 november 2003

Första postat (Uppskatta)

21 november 2003

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

6 februari 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 januari 2014

Senast verifierad

1 januari 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 11213

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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