- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00113529
Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell Carcinoma
25 augusti 2011 uppdaterad av: 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
42
Fas
- Fas 2
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109
- Pfizer Investigational Site
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New York
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New York, New York, Förenta staterna, 10021
- Pfizer Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19111-2497
- Pfizer Investigational Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Time to Tumor Response (TTR)
Tidsram: 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)
Tidsram: 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).
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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)
Tidsram: 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.
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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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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).
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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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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).
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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
Tidsram: 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).
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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
Tidsram: 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
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Change From Baseline in VEGF by Time Point Stratified by TTP >= Median and TTP < Median
Tidsram: 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
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Change From Baseline in VEGFC by Time Point Stratified by TTP >= Median and TTP < Median
Tidsram: 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
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Change From Baseline in VEGFR2 by Time Point Stratified by TTP >= Median and TTP < Median
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2004
Primärt slutförande (Faktisk)
1 september 2007
Avslutad studie (Faktisk)
1 oktober 2008
Studieregistreringsdatum
Först inskickad
8 juni 2005
Först inskickad som uppfyllde QC-kriterierna
8 juni 2005
Första postat (Uppskatta)
9 juni 2005
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
29 augusti 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 augusti 2011
Senast verifierad
1 augusti 2011
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Urologiska neoplasmer
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Njursjukdomar
- Urologiska sjukdomar
- Adenocarcinom
- Neoplasmer, körtel och epitel
- Neoplasmer i njurarna
- Karcinom, njurcell
- Carcinom
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Angiogeneshämmare
- Angiogenesmodulerande medel
- Tillväxtämnen
- Tillväxthämmare
- Proteinkinashämmare
- Sunitinib
- Gefitinib
Andra studie-ID-nummer
- A6181038
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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RenJi HospitalShanghai Zhongshan Hospital; Ruijin HospitalRekryteringClear Cell Renal Cell Carcinoma、Resistens mot immunterapiKina
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