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

25 agosto 2011 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

42

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109
        • Pfizer Investigational Site
    • New York
      • New York, New York, Stati Uniti, 10021
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19111-2497
        • Pfizer Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Droga: Gefitinib + Sunitinib
Until disease progression or unacceptable toxicity.
Altri nomi:
  • Iressa, SU011248, SUTENT

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Tumor Response (TTR)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline (Cycle 1, Day 1)
Concentration of VEGF at baseline.
Baseline (Cycle 1, Day 1)
VEGF Ratio to Baseline at Each Time Point
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline (Cycle 1, Day 1)
Concentration of sVEGFR2 at baseline.
Baseline (Cycle 1, Day 1)
sVEGFR2 Ratio to Baseline at Each Time Point
Lasso di tempo: 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
Lasso di tempo: Baseline (Cycle 1, Day 1)
Concentration of sVEGFR3 at baseline.
Baseline (Cycle 1, Day 1)
sVEGFR3 Ratio to Baseline at Each Time Point
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2004

Completamento primario (Effettivo)

1 settembre 2007

Completamento dello studio (Effettivo)

1 ottobre 2008

Date di iscrizione allo studio

Primo inviato

8 giugno 2005

Primo inviato che soddisfa i criteri di controllo qualità

8 giugno 2005

Primo Inserito (Stima)

9 giugno 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

29 agosto 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 agosto 2011

Ultimo verificato

1 agosto 2011

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A6181038

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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