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Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

15 augustus 2018 bijgewerkt door: Bayer

A Double-Blind Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Eligible subjects were randomized 1:1 to sorafenib 800 mg daily or matching placebo. Progression was assessed every 8 weeks by modified RECIST criteria. Subjects had the option to unblind study treatment after progression and to receive open label sorafenib regardless of initial treatment assignment. Following discontinuation of study treatment, subjects were followed for survival every 3 months in long-term follow-up. Subjects who terminated study treatment (either double only or double blind and open label) for reasons other than death, lost to follow-up or consent withdrawn entered long-term follow up

Studietype

Ingrijpend

Inschrijving (Werkelijk)

417

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • België
      • Bruxelles - Brussel, België, 1000
  • Bulgarije
      • Sofia, Bulgarije, 1527
  • China
      • Beijing, China, 100730
      • Beijing, China, 100021
      • Chengdu, China, 610041
      • Hangzhou, China, 310022
      • Shanghai, China, 200127
      • Shanghai, China, 200030
      • Tianjin, China, 300060
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
  • Denemarken
      • Odense C, Denemarken, 5000
  • Duitsland
    • Bayern
      • Erlangen, Bayern, Duitsland, 91054
      • München, Bayern, Duitsland, 81377
      • Würzburg, Bayern, Duitsland, 97080
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Duitsland, 45122
      • Köln, Nordrhein-Westfalen, Duitsland, 50924
    • Sachsen
      • Leipzig, Sachsen, Duitsland, 04103
  • Frankrijk
      • Angers, Frankrijk, 49933
      • Bordeaux, Frankrijk, 33076
      • Caen, Frankrijk, 14076
      • LILLE cedex, Frankrijk, 59037
      • Lyon, Frankrijk, 69373
      • MARSEILLE cedex, Frankrijk, 13273
      • Paris, Frankrijk, 75651
      • Villejuif, Frankrijk, 94805
  • Italië
    • Campania
      • Napoli, Campania, Italië, 80131
    • Liguria
      • Genova, Liguria, Italië, 16132
    • Lombardia
      • Milano, Lombardia, Italië, 20133
      • Milano, Lombardia, Italië, 20122
      • Milano, Lombardia, Italië, 20162
    • Sicilia
      • Catania, Sicilia, Italië, 95029
    • Toscana
      • Pisa, Toscana, Italië, 56124
      • Siena, Toscana, Italië, 53100
    • Umbria
      • Perugia, Umbria, Italië, 06126
  • Japan
    • Aichi
      • Nagoya, Aichi, Japan, 466-8560
      • Nagoya, Aichi, Japan, 464-8681
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
    • Tokyo
      • Koto-ku, Tokyo, Japan, 135-8550
  • Korea, republiek van
      • Daejeon, Korea, republiek van, 301-721
      • Seoul, Korea, republiek van, 137-701
      • Seoul, Korea, republiek van, 110-744
      • Seoul, Korea, republiek van, 120-752
      • Seoul, Korea, republiek van, 135-710
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, republiek van, 138-736
        • Asan Medical Center
  • Nederland
      • Groningen, Nederland, 9713 GZ
      • Leiden, Nederland, 2333 ZA
  • Oostenrijk
      • Wien, Oostenrijk, 1090
  • Polen
      • Gliwice, Polen, 44-101
      • Poznan, Polen, 60-355
      • Warszawa, Polen, 02-781
      • Warszawa, Polen, 04-141
  • Russische Federatie
      • Obninsk, Russische Federatie, 249036
  • Saoedi-Arabië
      • Riyadh, Saoedi-Arabië, 11211
  • Spanje
      • Barcelona, Spanje, 08035
    • Madrid
      • Majadahonda, Madrid, Spanje, 28222
  • Verenigd Koninkrijk
      • Cardiff, Verenigd Koninkrijk, CF14 2TL
      • Glasgow, Verenigd Koninkrijk, G12 0YN
      • Leeds, Verenigd Koninkrijk, LS9 7TF
      • London, Verenigd Koninkrijk, SE1 9RT
      • London, Verenigd Koninkrijk, SM2 5PT
      • Manchester, Verenigd Koninkrijk, M20 4BX
      • Newcastle Upon Tyne, Verenigd Koninkrijk, NE7 7DN
      • Sutton, Verenigd Koninkrijk, SM2 5PT
    • Aberdeenshire
      • Aberdeen, Aberdeenshire, Verenigd Koninkrijk, AB25 2ZN
  • Verenigde Staten
    • California
      • Los Angeles, California, Verenigde Staten, 90048
      • Stanford, California, Verenigde Staten, 94305-5820
    • Connecticut
      • New Haven, Connecticut, Verenigde Staten, 06520
    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30322
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02118
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48109
    • Missouri
      • Saint Louis, Missouri, Verenigde Staten, 63110
    • New Mexico
      • Albuquerque, New Mexico, Verenigde Staten, 87106
    • New York
      • New York, New York, Verenigde Staten, 10029
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15213-1863
    • Texas
      • Houston, Texas, Verenigde Staten, 77030
    • Washington
      • Seattle, Washington, Verenigde Staten, 98109-1023
  • Zweden
      • Göteborg, Zweden, 413 45
      • Linköping, Zweden, 581 85
      • Lund, Zweden, 221 85
      • Stockholm, Zweden, 171 76

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular and Hurthle cell)
  • Poorly differentiated and other thyroid variants (e.g. insular, tall cell, etc.) are eligible provided that the histology has no medullary differentiation nor anaplastic features
  • Progression within 14 months (RECIST [Response Evaluation Criteria in Solid Tumors] should be used as a basis for the assessment of disease progression)
  • RAI (radioactive iodine) refractory

Exclusion Criteria:

  • Histologic subtypes of thyroid cancer other than differentiated (i.e. like anaplastic and medullary carcinoma, lymphoma or sarcoma)
  • Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies (licensed or investigational) that target VEGF (vascular endothelial growth factor) or VEGF Receptors or other targeted agents
  • Prior anti-cancer treatment for thyroid cancer with use of chemotherapy (low dose chemotherapy for radiosensitization is allowed) or Thalidomide or any of its derivatives

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Sorafenib (Nexavar, BAY43-9006)
Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
Geneesmiddel: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg will be administered orally, twice daily (approximately every 12 hours).
Placebo-vergelijker: Placebo
Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
Geneesmiddel: Placebo
Placebo (2 tablets) will be administered orally, twice daily (approximately every 12 hours).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation
Tijdsspanne: Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years
PFS=time from randomization to first observed disease progression (radiological according to central assessment or clinical due to bone irradiation, whichever is earlier), or death due to any cause, if death occurred before progression. Progression was assessed by RECIST criteria, version 1.0, modified for bone lesions. PFS for participants without disease progression or death at the time of analysis or unblinding were censored at the last date of tumor assessment before unblinding. Participants with no tumor evaluation after baseline were censored at Day 1. PD (Progression Disease)=At least a 20% increase in sum of longest diameters (LD) of measured lesions taking as reference the smallest sum LD on study since the treatment started or the appearance of 1 or more new lesions. New lesions also constituted PD. In exceptional circumstances, unequivocal progression of a nonmeasured lesion may have been accepted as evidence of disease progression in participants with measurable disease.
Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival (OS)
Tijdsspanne: From randomization of the first subject until the database cut-off (30 AUG 2017), study duration approximately eight years
Overall survival was defined as the time (days) from date of randomization to date of death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Since the median value could not be estimated due to censored data, the percentage of participants who died is presented.
From randomization of the first subject until the database cut-off (30 AUG 2017), study duration approximately eight years
Time to Progression (TTP) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation
Tijdsspanne: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Time to progression was defined at the time (days) from randomization to progression (based on central assessment [radiological and clinical progression due to bone irradiation])
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Disease Control Rate (DCR) Based on Central Assessment
Tijdsspanne: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Disease control rate was defined as the proportion of subjects whose best response was complete response (CR), partial response (PR), or stable disease (SD). Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, CR and PR were to be confirmed by another scan at least 4 weeks later; SD had to be documented at least 4 weeks after date of randomization. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum. SD = steady state of disease which is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Response Rate Based on Central Assessment
Tijdsspanne: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Response rate was defined as the proportion of subjects whose best response was CR or PR. Per RECIST, CR and PR was to be confirmed by another scan at least 4 weeks later. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Duration of Response (DOR) Based on Central Assessment
Tijdsspanne: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Maximum Percent Reduction in Target Lesion Size Based on Central Assessment
Tijdsspanne: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
The magnitude of change from baseline in target lesion size in evaluable participants with scans was determined.
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
AUC(0-12h),ss (Area Under the Concentration Time Curve From Time 0 to 12 Hours at Steady State)
Tijdsspanne: A single pharmacokinetic plasma sample was collected at steady state (after 14 days of uninterrupted, unmodified sorafenib dosing)
Sorafenib AUC(0-12h),ss (area under the concentration time curve from time 0 to 12 hours at steady state) was estimated from the steady state plasma concentration.
A single pharmacokinetic plasma sample was collected at steady state (after 14 days of uninterrupted, unmodified sorafenib dosing)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Bayer

Medewerkers

Amgen

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 oktober 2009

Primaire voltooiing (Werkelijk)

31 augustus 2012

Studie voltooiing (Werkelijk)

30 augustus 2017

Studieregistratiedata

Eerst ingediend

24 september 2009

Eerst ingediend dat voldeed aan de QC-criteria

24 september 2009

Eerst geplaatst (Schatting)

25 september 2009

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 september 2018

Laatste update ingediend die voldeed aan QC-criteria

15 augustus 2018

Laatst geverifieerd

1 augustus 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 14295 (Andere identificatie: City of Hope Medical Center)
  • 2009-012007-25 (EudraCT-nummer)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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