- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00113529
Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell Carcinoma
25. August 2011 aktualisiert von: 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).
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
42
Phase
- Phase 2
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Michigan
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Ann Arbor, Michigan, Vereinigte Staaten, 48109
- Pfizer Investigational Site
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New York
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New York, New York, Vereinigte Staaten, 10021
- Pfizer Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19111-2497
- Pfizer Investigational Site
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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 |
Until disease progression or unacceptable toxicity.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)
Zeitfenster: 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.
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From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Time to Tumor Response (TTR)
Zeitfenster: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
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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.
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From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
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Duration of Response (DR)
Zeitfenster: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death due to cancer
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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).
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From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death due to cancer
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Time to Tumor Progression (TTP)
Zeitfenster: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
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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.
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From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
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Overall Survival (OS)
Zeitfenster: From start of study treatment until death
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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.
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From start of study treatment until death
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Progression-Free Survival (PFS)
Zeitfenster: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death
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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.
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From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death
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Probability of Survival at One Year
Zeitfenster: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter up until 1 year
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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.
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From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter up until 1 year
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VEGF (Vascular Endothelial Growth Factor) Concentration at Baseline
Zeitfenster: Baseline (Cycle 1, Day 1)
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Concentration of VEGF at baseline.
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Baseline (Cycle 1, Day 1)
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VEGF Ratio to Baseline at Each Time Point
Zeitfenster: Baseline to Cycle 3, Day 28 inclusive
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VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).
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Baseline to Cycle 3, Day 28 inclusive
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VEGF-C Concentration at Baseline
Zeitfenster: Baseline (Cycle 1, Day 1)
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Concentration of VEGF-C at baseline.
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Baseline (Cycle 1, Day 1)
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VEGF-C Ratio to Baseline at Each Time Point
Zeitfenster: Baseline to Cycle 3, Day 28 inclusive
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VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline).
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Baseline to Cycle 3, Day 28 inclusive
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Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline
Zeitfenster: Baseline (Cycle 1, Day 1)
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Concentration of sVEGFR2 at baseline.
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Baseline (Cycle 1, Day 1)
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sVEGFR2 Ratio to Baseline at Each Time Point
Zeitfenster: Baseline to Cycle 3, Day 28 inclusive
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sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).
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Baseline to Cycle 3, Day 28 inclusive
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Soluble VEGF Receptor 3 (sVEGFR3) Concentration at Baseline
Zeitfenster: Baseline (Cycle 1, Day 1)
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Concentration of sVEGFR3 at baseline.
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Baseline (Cycle 1, Day 1)
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sVEGFR3 Ratio to Baseline at Each Time Point
Zeitfenster: Baseline to Cycle 3, Day 28 inclusive
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sVEGFR3 concentration at each time point divided by sVEGFR3 concentration at baseline (ratio to baseline).
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Baseline to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGF by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Zeitfenster: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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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).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGFC by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Zeitfenster: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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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).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGFR2 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Zeitfenster: 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).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGFR3 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Zeitfenster: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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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).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGF by Time Point Stratified by PFS >= Median and PFS < Median
Zeitfenster: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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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).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGFC by Time Point Stratified by PFS >= Median and PFS < Median
Zeitfenster: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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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).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGFR2 by Time Point Stratified by PFS >= Median and PFS < Median
Zeitfenster: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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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).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGFR3 by Time Point Stratified by PFS >= Median and PFS < Median
Zeitfenster: 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).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGF by Time Point Stratified by TTP >= Median and TTP < Median
Zeitfenster: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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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).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGFC by Time Point Stratified by TTP >= Median and TTP < Median
Zeitfenster: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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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).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Change From Baseline in VEGFR2 by Time Point Stratified by TTP >= Median and TTP < Median
Zeitfenster: 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
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Change From Baseline in VEGFR3 by Time Point Stratified by TTP >= Median and TTP < Median
Zeitfenster: 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).
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Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
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Trough Plasma Concentrations (Ctrough) of Sunitinib
Zeitfenster: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
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prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
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Ctrough of SU-012662 (Sunitinib's Metabolite)
Zeitfenster: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
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prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
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Ctrough of Gefitinib
Zeitfenster: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
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prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Oktober 2004
Primärer Abschluss (Tatsächlich)
1. September 2007
Studienabschluss (Tatsächlich)
1. Oktober 2008
Studienanmeldedaten
Zuerst eingereicht
8. Juni 2005
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. Juni 2005
Zuerst gepostet (Schätzen)
9. Juni 2005
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
29. August 2011
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
25. August 2011
Zuletzt verifiziert
1. August 2011
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach histologischem Typ
- Neubildungen
- Urologische Neubildungen
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Nierenerkrankungen
- Urologische Erkrankungen
- Adenokarzinom
- Neubildungen, Drüsen und Epithelien
- Nierentumoren
- Karzinom, Nierenzelle
- Karzinom
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Angiogenese-Inhibitoren
- Angiogenese-modulierende Mittel
- Wuchsstoffe
- Wachstumshemmer
- Proteinkinase-Inhibitoren
- Sunitinib
- Gefitinib
Andere Studien-ID-Nummern
- A6181038
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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