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Trial record 1 of 1 for:    NCT00113529
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Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT00113529
Recruitment Status : Completed
First Posted : June 9, 2005
Results First Posted : March 31, 2010
Last Update Posted : August 29, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 8, 2005
First Posted Date  ICMJE June 9, 2005
Results First Submitted Date  ICMJE March 1, 2010
Results First Posted Date  ICMJE March 31, 2010
Last Update Posted Date August 29, 2011
Study Start Date  ICMJE October 2004
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2010)
Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00113529 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2010)
  • Time to Tumor Response (TTR) [ Time Frame: 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.
  • Duration of Response (DR) [ Time Frame: 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).
  • Time to Tumor Progression (TTP) [ Time Frame: 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.
  • Overall Survival (OS) [ Time Frame: 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.
  • Progression-Free Survival (PFS) [ Time Frame: 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.
  • Probability of Survival at One Year [ Time Frame: 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.
  • VEGF (Vascular Endothelial Growth Factor) Concentration at Baseline [ Time Frame: Baseline (Cycle 1, Day 1) ]
    Concentration of VEGF at baseline.
  • VEGF Ratio to Baseline at Each Time Point [ Time Frame: Baseline to Cycle 3, Day 28 inclusive ]
    VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).
  • VEGF-C Concentration at Baseline [ Time Frame: Baseline (Cycle 1, Day 1) ]
    Concentration of VEGF-C at baseline.
  • VEGF-C Ratio to Baseline at Each Time Point [ Time Frame: Baseline to Cycle 3, Day 28 inclusive ]
    VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline).
  • Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline [ Time Frame: Baseline (Cycle 1, Day 1) ]
    Concentration of sVEGFR2 at baseline.
  • sVEGFR2 Ratio to Baseline at Each Time Point [ Time Frame: Baseline to Cycle 3, Day 28 inclusive ]
    sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).
  • Soluble VEGF Receptor 3 (sVEGFR3) Concentration at Baseline [ Time Frame: Baseline (Cycle 1, Day 1) ]
    Concentration of sVEGFR3 at baseline.
  • sVEGFR3 Ratio to Baseline at Each Time Point [ Time Frame: Baseline to Cycle 3, Day 28 inclusive ]
    sVEGFR3 concentration at each time point divided by sVEGFR3 concentration at baseline (ratio to baseline).
  • Change From Baseline in VEGF by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD) [ Time Frame: 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).
  • Change From Baseline in VEGFC by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD) [ Time Frame: 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).
  • Change From Baseline in VEGFR2 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD) [ Time Frame: 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).
  • Change From Baseline in VEGFR3 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD) [ Time Frame: 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).
  • Change From Baseline in VEGF by Time Point Stratified by PFS >= Median and PFS < Median [ Time Frame: 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).
  • Change From Baseline in VEGFC by Time Point Stratified by PFS >= Median and PFS < Median [ Time Frame: 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).
  • Change From Baseline in VEGFR2 by Time Point Stratified by PFS >= Median and PFS < Median [ Time Frame: 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).
  • Change From Baseline in VEGFR3 by Time Point Stratified by PFS >= Median and PFS < Median [ Time Frame: 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).
  • Change From Baseline in VEGF by Time Point Stratified by TTP >= Median and TTP < Median [ Time Frame: 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).
  • Change From Baseline in VEGFC by Time Point Stratified by TTP >= Median and TTP < Median [ Time Frame: 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).
  • Change From Baseline in VEGFR2 by Time Point Stratified by TTP >= Median and TTP < Median [ Time Frame: 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).
  • Change From Baseline in VEGFR3 by Time Point Stratified by TTP >= Median and TTP < Median [ Time Frame: 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).
  • Trough Plasma Concentrations (Ctrough) of Sunitinib [ Time Frame: 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) [ Time Frame: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28) ]
  • Ctrough of Gefitinib [ Time Frame: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28) ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell Carcinoma
Official Title  ICMJE A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Gefitinib (Iressa) In Patients With Metastatic Renal Cell Carcinoma
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Renal Cell
Intervention  ICMJE Drug: Gefitinib + Sunitinib
Until disease progression or unacceptable toxicity.
Other Name: Iressa, SU011248, SUTENT
Study Arms  ICMJE 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

Intervention: Drug: Gefitinib + Sunitinib
Publications * Motzer RJ, Hudes GR, Ginsberg MS, Baum MS, Harmon CS, Kim ST, Chen I, Redman BG. Phase I/II trial of sunitinib plus gefitinib in patients with metastatic renal cell carcinoma. Am J Clin Oncol. 2010 Dec;33(6):614-8. doi: 10.1097/COC.0b013e3181c4454d.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2007)
42
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00113529
Other Study ID Numbers  ICMJE A6181038
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP