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Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell Carcinoma

25. august 2011 opdateret af: Pfizer

A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Gefitinib (Iressa) In Patients With Metastatic Renal Cell Carcinoma

To assess the maximum tolerated dose and overall safety and tolerability of sunitinib [SU011248] administered in combination with gefitinib (Iressa) for the treatment of patients with metastatic renal cell carcinoma (Phase 1). To assess antitumor activity of the combination of gefitinib and sunitinib (Phase 2).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

42

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • Pfizer Investigational Site
    • New York
      • New York, New York, Forenede Stater, 10021
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19111-2497
        • 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:

  • Histologically confirmed renal cell carcinoma with metastases
  • Evidence of unidimensionally measurable disease
  • Failure of 1 prior immunotherapy or no prior systemic therapy for metastatic RCC

Exclusion Criteria:

  • RCC without any clear (conventional) cell component
  • History of or known brain metastases
  • Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study entry

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: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sunitinib + Gefitinib

Phase 1 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib; 50 mg Sunitinib + 250 mg Gefitinib

Phase 2 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib
Medicin: Gefitinib + Sunitinib
Until disease progression or unacceptable toxicity.
Andre navne:
  • Iressa, SU011248, SUTENT

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)
Tidsramme: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Tumor Response (TTR)
Tidsramme: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
TTR was defined as the time from date of the first dose of study medication to first documentation of objective tumor response (CR or PR). For subjects proceeding from PR to CR, the onset of PR was taken as the onset of response. If lesion assessment data included more than 1 date, the first date was used. TTR was calculated as (first event date minus first dose date +1)/7. TTR was calculated based on the subgroup of subjects with a baseline disease assessment, who had the correct histological cancer type, and had a confirmed objective tumor response. Kaplan-Meier method was used.
From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
Duration of Response (DR)
Tidsramme: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death due to cancer
DR was defined as the time from start of the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1)/7. DR was calculated for the subgroup of subjects with an objective tumor response (CR or PR).
From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death due to cancer
Time to Tumor Progression (TTP)
Tidsramme: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
TTP was defined as the time from the date of first dose of study medication to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.
From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
Overall Survival (OS)
Tidsramme: From start of study treatment until death
OS was defined as the time from date of the first dose of study medication to date of death due to any cause. OS (in weeks) is calculated as (date of death minus first dose date +1)/7. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose had their survival times censored at 1 day. Kaplan-Meier method was used.
From start of study treatment until death
Progression-Free Survival (PFS)
Tidsramme: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death
PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.
From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death
Probability of Survival at One Year
Tidsramme: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter up until 1 year
Survival rate was defined as the percentage of subjects alive at 1 year after the date of first administration of study medication. Survival rate was estimated using the Kaplan-Meier method.
From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter up until 1 year
VEGF (Vascular Endothelial Growth Factor) Concentration at Baseline
Tidsramme: Baseline (Cycle 1, Day 1)
Concentration of VEGF at baseline.
Baseline (Cycle 1, Day 1)
VEGF Ratio to Baseline at Each Time Point
Tidsramme: Baseline to Cycle 3, Day 28 inclusive
VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).
Baseline to Cycle 3, Day 28 inclusive
VEGF-C Concentration at Baseline
Tidsramme: Baseline (Cycle 1, Day 1)
Concentration of VEGF-C at baseline.
Baseline (Cycle 1, Day 1)
VEGF-C Ratio to Baseline at Each Time Point
Tidsramme: Baseline to Cycle 3, Day 28 inclusive
VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline).
Baseline to Cycle 3, Day 28 inclusive
Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline
Tidsramme: Baseline (Cycle 1, Day 1)
Concentration of sVEGFR2 at baseline.
Baseline (Cycle 1, Day 1)
sVEGFR2 Ratio to Baseline at Each Time Point
Tidsramme: Baseline to Cycle 3, Day 28 inclusive
sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).
Baseline to Cycle 3, Day 28 inclusive
Soluble VEGF Receptor 3 (sVEGFR3) Concentration at Baseline
Tidsramme: Baseline (Cycle 1, Day 1)
Concentration of sVEGFR3 at baseline.
Baseline (Cycle 1, Day 1)
sVEGFR3 Ratio to Baseline at Each Time Point
Tidsramme: Baseline to Cycle 3, Day 28 inclusive
sVEGFR3 concentration at each time point divided by sVEGFR3 concentration at baseline (ratio to baseline).
Baseline to Cycle 3, Day 28 inclusive
Change From Baseline in VEGF by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Tidsramme: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGF level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFC by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Tidsramme: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGFC level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR2 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Tidsramme: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGFR2 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR3 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Tidsramme: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGFR3 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGF by Time Point Stratified by PFS >= Median and PFS < Median
Tidsramme: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGF level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFC by Time Point Stratified by PFS >= Median and PFS < Median
Tidsramme: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGFC level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR2 by Time Point Stratified by PFS >= Median and PFS < Median
Tidsramme: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGFR2 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR3 by Time Point Stratified by PFS >= Median and PFS < Median
Tidsramme: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGFR3 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGF by Time Point Stratified by TTP >= Median and TTP < Median
Tidsramme: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGF level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFC by Time Point Stratified by TTP >= Median and TTP < Median
Tidsramme: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGFC level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR2 by Time Point Stratified by TTP >= Median and TTP < Median
Tidsramme: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGFR2 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR3 by Time Point Stratified by TTP >= Median and TTP < Median
Tidsramme: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change = median VEGFR3 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Trough Plasma Concentrations (Ctrough) of Sunitinib
Tidsramme: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
Ctrough of SU-012662 (Sunitinib's Metabolite)
Tidsramme: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
Ctrough of Gefitinib
Tidsramme: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)

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. oktober 2004

Primær færdiggørelse (Faktiske)

1. september 2007

Studieafslutning (Faktiske)

1. oktober 2008

Datoer for studieregistrering

Først indsendt

8. juni 2005

Først indsendt, der opfyldte QC-kriterier

8. juni 2005

Først opslået (Skøn)

9. juni 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. august 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. august 2011

Sidst verificeret

1. august 2011

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A6181038

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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