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A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone (SUN1058)

31. januar 2013 opdateret af: Pfizer

Randomized, Double-Blind, Phase 2 Study Of Erlotinib With Or Without SU011248 In The Treatment Of Metastatic Non-Small Cell Lung Cancer

This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

162

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Pfizer Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Pfizer Investigational Site
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, Forenede Stater, 35294
        • Pfizer Investigational Site
      • Mobile, Alabama, Forenede Stater, 36604
        • Pfizer Investigational Site
    • California
      • Antioch, California, Forenede Stater, 94531
        • Pfizer Investigational Site
      • Palm Springs, California, Forenede Stater, 92262-4885
        • Pfizer Investigational Site
      • Pleasant Hill, California, Forenede Stater, 94523
        • Pfizer Investigational Site
      • San Leandro, California, Forenede Stater, 94578
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Pfizer Investigational Site
    • Missouri
      • Creve Coeur, Missouri, Forenede Stater, 63141
        • Pfizer Investigational Site
      • St. Louis, Missouri, Forenede Stater, 63110
        • Pfizer Investigational Site
      • St. Louis, Missouri, Forenede Stater, 63110-1094
        • Pfizer Investigational Site
      • St. Peters, Missouri, Forenede Stater, 63376
        • Pfizer Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599-7600
        • Pfizer Investigational Site
      • Clinton, North Carolina, Forenede Stater, 28328
        • Pfizer Investigational Site
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Pfizer Investigational Site
      • Wilson, North Carolina, Forenede Stater, 27893
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Pfizer Investigational Site
  • Holland
      • Amsterdam, Holland, 1066 CX
        • Pfizer Investigational Site
      • Groningen, Holland, 9713 GZ
        • Pfizer Investigational Site
  • Italien
      • Genova, Italien, 16132
        • Pfizer Investigational Site
      • Monteforte Irpino, AV, Italien, 83024
        • Pfizer Investigational Site
  • Polen
      • Bydgoszcz, Polen, 85-796
        • Pfizer Investigational Site
      • Gdansk, Polen, 80-952
        • Pfizer Investigational Site
  • Rumænien
      • Bucuresti, Rumænien, 30171
        • Pfizer Investigational Site
    • Cluj
      • Cluj-Napoca, Cluj, Rumænien, 400015
        • Pfizer Investigational Site
    • Sector 2
      • Bucuresti, Sector 2, Rumænien, 022328
        • Pfizer Investigational Site
  • Spanien
    • Cantabria
      • Santander, Cantabria, Spanien, 39008
        • Pfizer Investigational Site
  • Ungarn
      • Budapest, Ungarn, 1525
        • Pfizer Investigational Site
      • Torokbalint, Ungarn, 2045
        • Pfizer Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with locally advanced/metastatic non-small cell lung cancer
  • Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen

Exclusion Criteria:

  • Prior treatment with any receptor tyrosine kinase inhibitors, Vascular endothelial growth factor (VEGF) inhibitors or other angiogenic inhibitors
  • History of or known brain metastases

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: B
Medicin: erlotinib
erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
Medicin: placebo
Placebo daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
Eksperimentel: EN
Medicin: erlotinib
erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
Medicin: sunitinib
Sunitinib 37.5 mg daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
Andre navne:
  • Sutent

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-Free Survival (PFS)
Tidsramme: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
PFS=time from randomization date to date of first documentation of progressive disease (PD; defined as greater than or equal to [≥]20% increase in sum of longest dimensions of target lesions taking as a reference smallest sum of longest dimensions recorded since first dose or appearance of ≥1 new lesions) or death on-study due to any cause, whichever occurred first based on third party independent imaging review laboratory assessment. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02. Used 7.02 days as it equals 365 days per year divided by 52 weeks per year.
From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Objective Response
Tidsramme: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
Objective Response Rate (ORR)=participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST,Version 1.0) based on third party independent imaging review laboratory assessment. A CR was defined as the disappearance of all target lesions that persisted on repeat imaging study at least 4 weeks after initial documentation of response. A PR was defined as a ≥30% decrease in sum of longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.
From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
Time to Tumor Progression (TTP)
Tidsramme: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
TTP was defined as the time from date of randomization to first documentation of PD based on third party independent imaging review laboratory assessment. TTP was calculated as (first event date minus randomization date plus 1) divided by 7.02.
From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
Duration of Response (DR)
Tidsramme: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
DR was defined as time from first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of PD or death on-study due to any cause, whichever occurred first. DR was calculated as (first date of PD or death minus first date of CR or PR that was subsequently confirmed plus 1) divided by 7.02.
From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
Overall Survival (OS)
Tidsramme: From randomization until death (up to Month 17)
OS was defined as time from date of randomization to date of death due to any cause. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.
From randomization until death (up to Month 17)
Percentage of Participants Surviving at 1 Year
Tidsramme: From randomization until death (up until Month 17)
Percentage of participants alive at 1 year after date of first administration of study medication.
From randomization until death (up until Month 17)
Area Under the Curve From Time Zero to 24 Hours [AUC(0-24)] of Erlotinib
Tidsramme: Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose
AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of erlotinib
Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose
AUC(0-24) of Sunitinib
Tidsramme: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose
AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of sunitinib
Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose
AUC(0-24) of SU-012662 (Metabolite of Sunitinib)
Tidsramme: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose
AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of SU-012662 (metabolite of sunitinib)
Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose
AUC(0-24) of Total Drug (Sunitinib + SU-012662)
Tidsramme: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose
AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of total drug (sunitinib + SU-012662)
Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose
Maximum Observed Plasma Concentration (Cmax) of Erlotinib
Tidsramme: Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose
Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose
Cmax of Sunitinib
Tidsramme: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose
Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose
Cmax of SU-012662 (Metabolite of Sunitinib)
Tidsramme: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose
Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose
Cmax of Total Drug (Sunitinib + SU-012662)
Tidsramme: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose
Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) for Erlotinib
Tidsramme: Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose; predose on Days 22 and 23 (Cycle 1)
AUC (0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for erlotinib. It is obtained from AUC from time zero (pre-dose) to last quantifiable concentration(AUC[0-t]) plus AUC from time last quantifiable concentration extrapolated infinite time (AUC[t-inf])
Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose; predose on Days 22 and 23 (Cycle 1)
AUC(0-inf) for Sunitinib
Tidsramme: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)
AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for sunitinib. It is obtained from AUC(0-t) plus AUC(t-inf)
Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)
AUC(0-inf) for SU-012662 (Metabolite of Sunitinib)
Tidsramme: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)
AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for SU-012662 (metabolite of sunitinib). It is obtained from AUC(0-t) plus AUC(t-inf)
Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)
AUC(0-inf) for Total Drug (Sunitinib + SU-012662)
Tidsramme: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)
AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for total drug (sunitinib + SU-012662). It is obtained from AUC(0-t) plus AUC(t-inf)
Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)
Plasma Decay Half-life (t1/2) of Erlotinib
Tidsramme: Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose
Plasma Decay Half-life (t1/2) of Sunitinib
Tidsramme: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose
Erlotinib Clearance at Steady State After Oral Administration (CL/F)
Tidsramme: Day 15 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose
Day 15 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose
Sunitinib Clearance at Steady State After Oral Administration (CL/F)
Tidsramme: Day 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose
Day 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Erlotinib
Tidsramme: Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose
Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose
Tmax for Sunitinib
Tidsramme: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose
Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose
Tmax for SU-012662 (Metabolite of Sunitinib)
Tidsramme: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose
Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose
Tmax for Total Drug (Sunitinib + SU-012662)
Tidsramme: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose
Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose
Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)
Tidsramme: predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)
Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.
predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)
Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)
Tidsramme: predose Day 15 (Cycle1); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)
Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.
predose Day 15 (Cycle1); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)
Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)
Tidsramme: predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)
Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.
predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)
Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)
Tidsramme: predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)
Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.
predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)
Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)
Tidsramme: predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)
Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.
predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)
Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)
Tidsramme: predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)
Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.
predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)
Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff
Tidsramme: Baseline
Percentage of participants with EGFR expression by IHC using a 0% cutoff; Reported as positive, negative, or unmeasured (where positive was greater than 0% of cells demonstrating membranous staining for EGFR). Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.
Baseline
PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff)
Tidsramme: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 0% cutoff where positive was greater than 0% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02.
From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff)
Tidsramme: Baseline
Percentage of participants with EGFR Expression by IHC using a 10% cutoff; Reported as positive (positive values were defined as being greater than 10% of cells demonstrating membranous staining for EGFR), negative, or unmeasured. Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.
Baseline
PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff)
Tidsramme: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 10% cutoff where positive was greater than 10% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02.
From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
Percentage of Participants With EGFR Gene Copy Number Increase
Tidsramme: Baseline
The number of copies corresponding to exon 19 of the EGFR gene was determined by real-time quantitative polymerase chain reaction (PCR). The percentage of participants with EGFR Gene Copy Number Increase (defined as greater than 4 copies) was determined using deoxyribonucleic acid (DNA) from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. Reported as yes, no or unmeasured.
Baseline
PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase
Tidsramme: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
PFS, defined as time from date of randomization to the date of the first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene copy number increase (reported as yes, no, or unmeasured). The number of copies corresponding to exon 19 of the EGFR gene was determined and an increase was defined as greater than 4 copies. PFS was calculated as (first event date minus randomization date plus 1)/7.02.
From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
Percentage of Participants With EGFR Gene Amplification
Tidsramme: Baseline
The percentage of participants with EGFR gene amplification (defined as greater than 15) was determined and reported as yes, no, or unmeasured. Correlative analysis of EGFR gene amplification was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.
Baseline
PFS in Subgroups That Were Defined by EGFR Gene Amplification
Tidsramme: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene amplification (defined as greater than 15) and reported as no or unmeasured. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.
From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
Percentage of Participants With EGFR Gene Mutation
Tidsramme: Baseline
Mutations in exons 18 through 21 of the EGFR gene were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with EGFR mutations categorized as mutated, wild type or indeterminate was reported.
Baseline
PFS in Subgroups That Were Defined by EGFR Gene Mutation
Tidsramme: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
PFS, defined as time from date of randomization to date of first documentation of PD or to death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.
From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations
Tidsramme: Baseline
Mutations in exons 2-3 of the KRAS gene (including codons 12, 13, and 61) were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with KRAS mutations categorized as mutated, wild type or indeterminate was reported.
Baseline
PFS in Subgroups That Were Defined by KRAS Gene Mutation
Tidsramme: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by KRAS gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.
From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms
Tidsramme: Baseline
Blood samples were collected at baseline for multiplex reverse transcription (RT) analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline VEGFR2 single nucleotide polymorphisms (SNPs) was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, G/T, T/A, and G/A.
Baseline
PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms
Tidsramme: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by VEGFR2 polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.
From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms
Tidsramme: From randomization until death (up to Month 17)
OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by VEGFR2 polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4.
From randomization until death (up to Month 17)
Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms
Tidsramme: Baseline
Blood samples were collected at baseline for multiplex RT analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline PDGFRB SNPs was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, A/T, A/G, T/C, T/G, G/C, C/A and G/A.
Baseline
PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms
Tidsramme: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by PDGFRB polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.
From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms
Tidsramme: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by PDGFRB polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4.
From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
Percentage of Participants by Tumor VEGFR Mutation
Tidsramme: Baseline
Percentage of participants with VEGFR mutations in DNA from tumor samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.
Baseline
Correlation of Polymorphisms in Stem Cell Factor Receptor (c-Kit), FMS-like Tyrosine Kinase 3 Receptor (FLT-3), and c-FMS With Blood Counts
Tidsramme: Baseline (Day 1, Cycle 1)
A blood sample (6 mL) was collected before on-study treatment and was used to isolate DNA. These samples were not anonymized. Correlation was investigated by the percentage of participants with anemia (based on hemoglobin count), neutropenia (based on neutrophil count) and thrombocytopenia (based on platelet count) endpoints and genetic variation as measured by c-KIT, FLT-3, and c-FMS was to be analyzed.
Baseline (Day 1, Cycle 1)
Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile
Tidsramme: Baseline
Includes colony-stimulating factor 1 receptor (CSF-1R), PDGFRalpha, PDGFRbeta, vascular endothelial growth factor (VEGF), VEGF C (VEGF-C), VEGF receptor 1 (VEGFR1), VEGF receptor 2 (VEGFR2), VEGF receptor 3 (VEGFR3), fibroblast growth factor (FGF), FLT-3, KIT (stem cell factor receptor), and RET (rearranged during transfection). Correlative analysis was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.
Baseline
PFS in Subgroups That Were Defined by RNA Expression Profile
Tidsramme: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT-3, KIT, and RET). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.
From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score
Tidsramme: Baseline (Cycle [C] 1, Day [D] 1) to Cycle 18, Day 1
EORTC QLQ-C30: self-administered questionnaire assessing global health status/quality of life (QoL), functional domains (physical, role, cognitive, emotional, and social), symptom scales/items (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea), and financial difficulties. Recall period: past week; response range: not at all (1) to very much (4); global/QoL range: very poor (1) to excellent (7). Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Baseline (Cycle [C] 1, Day [D] 1) to Cycle 18, Day 1
EORTC-QLQ-C30 Lung Cancer Module (LC13) Score
Tidsramme: Baseline (Cycle 1 [Day 1]) to Cycle 18 (Day 1)
The EORTC-QLQ-C30 LC13 is a self-administered questionnaire assessing specific lung cancer disease related symptoms (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in the chest, arm/shoulder or other parts of the body). Recall period: past week; response range: not at all (1) to very much (4). Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.
Baseline (Cycle 1 [Day 1]) to Cycle 18 (Day 1)
Number of Participants With Blood Pressure (BP) Greater Than 150/100 Millimeters of Mercury (mmHg)
Tidsramme: Randomization up until Month 17
Systolic/diastolic BP measured in triplicate (separated by approximately 2 minutes [min]) using validated electronic device (same device for all measurements), recorded to nearest mmHg. Dominant arm used (same one each time) with appropriate cuff size encircling at least 80% of arm. BP measured after 5 min rest and before invasive procedures, while seated in a chair with back supported, arms bared, supported at heart level. No smoking or caffeine use allowed during 30 min before measurement. Number of participants with systolic BP >150 mmHg/diastolic BP >100 mmHg at any timepoint postbaseline.
Randomization up until Month 17
Number of Participants With BP Greater Than 200/110 mmHg
Tidsramme: Randomization up until Month 17
Systolic/diastolic BP measured in triplicate (separated by approximately 2 minutes [min]) using validated electronic device (same device for all measurements), recorded to nearest mmHg. Dominant arm used (same one each time) with appropriate cuff size encircling at least 80% of arm. BP measured after 5 min rest and before invasive procedures, while seated in a chair with back supported, arms bared, supported at heart level. No smoking or caffeine use allowed during 30 min before measurement. Number of participants with systolic BP >150 mmHg/diastolic BP >100 mmHg at any timepoint postbaseline.
Randomization up until Month 17
Number of Participants on Anti-hypertensive Medications
Tidsramme: Randomization to Day 28 of Cycle 18
Number of participants with BP greater than 150/100 mmHg or 200/110 mmHg who were treated with anti-hypertensive medications.
Randomization to Day 28 of Cycle 18
Plasma Concentration of VEGF-C at Baseline
Tidsramme: Baseline (Cycle 1, Day 1)
Baseline (Cycle 1, Day 1)
Plasma Concentration of Soluble VEGFR-2 at Baseline
Tidsramme: Baseline (Cycle 1, Day 1)
Baseline (Cycle 1, Day 1)
Plasma Concentration of Soluble VEGFR-3 at Baseline
Tidsramme: Baseline (Cycle 1, Day 1)
Baseline (Cycle 1, Day 1)
Plasma Concentration of Soluble KIT (sKIT) at Baseline
Tidsramme: Baseline (Cycle 1, Day 1)
Baseline (Cycle 1, Day 1)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
VEGF-C Ratio to Baseline at Each Timepoint
Tidsramme: Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)
Plasma VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline)
Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)
VEGFR-2 Ratio to Baseline at Each Timepoint
Tidsramme: Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)
Plasma VEGFR-2 concentration at each time point divided by VEGFR-2 concentration at baseline (ratio to baseline)
Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)
VEGFR-3 Ratio to Baseline at Each Timepoint
Tidsramme: Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)
Plasma VEGFR-3 concentration at each time point divided by VEGFR-3 concentration at baseline (ratio to baseline)
Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)
sKIT Ratio to Baseline at Each Timepoint
Tidsramme: Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)
Plasma sKIT concentration at each time point divided by sKIT concentration at baseline (ratio to baseline)
Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2006

Primær færdiggørelse (Faktiske)

1. januar 2010

Studieafslutning (Faktiske)

1. januar 2012

Datoer for studieregistrering

Først indsendt

12. december 2005

Først indsendt, der opfyldte QC-kriterier

12. december 2005

Først opslået (Skøn)

14. december 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. februar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. januar 2013

Sidst verificeret

1. januar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A6181058

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