SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma

A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma

The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).

Study Overview

• Status: Completed
• Conditions: Carcinoma, Renal Cell
• Intervention / Treatment: Drug: Interferon-alfa; Drug: SU011248

• Study Type: Interventional
• Enrollment (Actual): 750
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Victoria, Australia, 36184
    • Pfizer Investigational Site
  • New South Wales
    • Lismore, New South Wales, Australia, 2480
      • Pfizer Investigational Site
    • St. Leonards, New South Wales, Australia, 2065
      • Pfizer Investigational Site
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Pfizer Investigational Site
  • South Australia
    • Woodville South, South Australia, Australia, 5011
      • Pfizer Investigational Site
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Pfizer Investigational Site
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • Pfizer Investigational Site
• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20231-050
      • Pfizer Investigational Site
  • RS
    • Porto Alegre, RS, Brazil, 90610-000
      • Pfizer Investigational Site
    • Porto Alegre, RS, Brazil, 90020-090
      • Pfizer Investigational Site
• Canada
  • Quebec, Canada, G1S 2L6
    • Pfizer Investigational Site
  • Quebec, Canada, G1R 2J6
    • Pfizer Investigational Site
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Pfizer Investigational Site
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Pfizer Investigational Site
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y5L3
      • Pfizer Investigational Site
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Pfizer Investigational Site
    • Victoria, British Columbia, Canada, V5Z 4E6
      • Pfizer Investigational Site
  • Ontario
    • London, Ontario, Canada, N6A 4L6
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M4N 3M5
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M5G 2M9
      • Pfizer Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • Pfizer Investigational Site
• France
  • Lyon, France, 69008
    • Pfizer Investigational Site
  • Paris Cedex 13, France, 75651
    • Pfizer Investigational Site
  • Rennes, France, 35042
    • Pfizer Investigational Site
  • Saint Herblain, France
    • Pfizer Investigational Site
  • Vandoeuvre Les Nancy, France, 54511
    • Pfizer Investigational Site
  • Cedex 15
    • Paris, Cedex 15, France, 75908
      • Pfizer Investigational Site
• Germany
  • Aachen, Germany, 52074
    • Pfizer Investigational Site
  • Essen, Germany, 45122
    • Pfizer Investigational Site
  • Hannover, Germany, 30625
    • Pfizer Investigational Site
  • Ulm, Germany, 89075
    • Pfizer Investigational Site
  • Ulm, Germany, 89081
    • Pfizer Investigational Site
• Italy
  • Modena, Italy, 41100
    • Pfizer Investigational Site
  • Napoli, Italy, 80131
    • Pfizer Investigational Site
  • Pavia, Italy
    • Pfizer Investigational Site
  • Roma, Italy, 00144
    • Pfizer Investigational Site
  • Roma, Italy, 00152
    • Pfizer Investigational Site
  • Roma, Italy, 00135
    • Pfizer Investigational Site
• Poland
  • Gdansk, Poland, 80-210
    • Pfizer Investigational Site
  • Krakow, Poland, 31-115
    • Pfizer Investigational Site
  • Lodz, Poland, 93-509
    • Pfizer Investigational Site
  • Lublin, Poland, 20-090
    • Pfizer Investigational Site
  • Poznan, Poland
    • Pfizer Investigational Site
  • Warszawa, Poland, 00-909
    • Pfizer Investigational Site
  • Wroclaw, Poland, 50-556
    • Pfizer Investigational Site
  • Wroclaw, Poland, 50-043
    • Pfizer Investigational Site
  • Warszawa
    • Moczowego, Warszawa, Poland
      • Pfizer Investigational Site
• Russian Federation
  • Chelyabinsk, Russian Federation, 454087
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 115478
    • Pfizer Investigational Site
  • Moscow, Russian Federation
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 117836
    • Pfizer Investigational Site
  • Saint-Petersburg, Russian Federation, 197758
    • Pfizer Investigational Site
  • St. Petersburg, Russian Federation, 197758
    • Pfizer Investigational Site
  • Tomsk, Russian Federation, 634050
    • Pfizer Investigational Site
  • Kaluga Region
    • Obninsk, Kaluga Region, Russian Federation, 249036
      • Pfizer Investigational Site
• Spain
  • Madrid, Spain, 28041
    • Pfizer Investigational Site
  • Madrid, Spain, 28040
    • Pfizer Investigational Site
  • Sevilla, Spain, 41013
    • Pfizer Investigational Site
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Pfizer Investigational Site
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Pfizer Investigational Site
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Pfizer Investigational Site
  • London, United Kingdom, SW3 6JJ
    • Pfizer Investigational Site
  • Sutton Surrey, United Kingdom, SM2 5PT
    • Pfizer Investigational Site
  • Cardiff
    • Whitchurch, Cardiff, United Kingdom, CF14 2 TL
      • Pfizer Investigational Site
  • Lancashire
    • Manchester, Lancashire, United Kingdom, M20 4BX
      • Pfizer Investigational Site
  • Middlesex
    • Northwood, Middlesex, United Kingdom, HA6 2RN
      • Pfizer Investigational Site
• United States
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Pfizer Investigational Site
  • California
    • La Jolla, California, United States, 92037
      • Pfizer Investigational Site
    • La Jolla, California, United States, 92093
      • Pfizer Investigational Site
    • Los Angeles, California, United States, 90095
      • Pfizer Investigational Site
    • San Diego, California, United States, 92103
      • Pfizer Investigational Site
    • San Francisco, California, United States, 94115
      • Pfizer Investigational Site
  • Colorado
    • Aurora, Colorado, United States, 80040-0510
      • Pfizer Investigational Site
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Investigational Site
    • New Haven, Connecticut, United States, 06520
      • Pfizer Investigational Site
    • New Haven, Connecticut, United States, 06504
      • Pfizer Investigational Site
  • Florida
    • Miami, Florida, United States, 33136
      • Pfizer Investigational Site
    • Miami, Florida, United States, 33176
      • Pfizer Investigational Site
    • Tampa, Florida, United States, 33612
      • Pfizer Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Pfizer Investigational Site
    • Maywood, Illinois, United States, 60153
      • Pfizer Investigational Site
  • Kansas
    • Kansas City, Kansas, United States, 66112
      • Pfizer Investigational Site
    • Overland Park, Kansas, United States, 66210
      • Pfizer Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Pfizer Investigational Site
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Pfizer Investigational Site
    • Metairie, Louisiana, United States, 70006
      • Pfizer Investigational Site
    • Metairie, Louisiana, United States, 70002
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Pfizer Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Pfizer Investigational Site
    • Boston, Massachusetts, United States, 02115
      • Pfizer Investigational Site
  • Michigan
    • Detoit, Michigan, United States, 48201
      • Pfizer Investigational Site
    • Detroit, Michigan, United States, 48201
      • Pfizer Investigational Site
    • Farmington Hills, Michigan, United States, 48334
      • Pfizer Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Pfizer Investigational Site
  • Mississippi
    • Columbus, Mississippi, United States, 39705
      • Pfizer Investigational Site
    • Corinth, Mississippi, United States, 38834
      • Pfizer Investigational Site
    • Jackson, Mississippi, United States, 39216
      • Pfizer Investigational Site
    • Jackson, Mississippi, United States, 39213
      • Pfizer Investigational Site
    • Southaven, Mississippi, United States, 38671
      • Pfizer Investigational Site
    • Tupelo, Mississippi, United States, 38801
      • Pfizer Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • Pfizer Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68198-9200
      • Pfizer Investigational Site
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Pfizer Investigational Site
  • New York
    • Bronx, New York, United States, 10466
      • Pfizer Investigational Site
    • New York, New York, United States, 10021
      • Pfizer Investigational Site
    • New York, New York, United States, 10022
      • Pfizer Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Pfizer Investigational Site
    • Cleveland, Ohio, United States, 44106-5055
      • Pfizer Investigational Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Pfizer Investigational Site
    • Tulsa, Oklahoma, United States, 74136
      • Pfizer Investigational Site
    • Tulsa, Oklahoma, United States, 74104
      • Pfizer Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97210
      • Pfizer Investigational Site
    • Portland, Oregon, United States, 97239
      • Pfizer Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111-2497
      • Pfizer Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Pfizer Investigational Site
    • Memphis, Tennessee, United States, 38120
      • Pfizer Investigational Site
    • Nashville, Tennessee, United States, 37232
      • Pfizer Investigational Site
  • Texas
    • Dallas, Texas, United States, 75246
      • Pfizer Investigational Site
    • Houston, Texas, United States, 77030
      • Pfizer Investigational Site
    • Tyler, Texas, United States, 75702
      • Pfizer Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Pfizer Investigational Site
  • Washington
    • Seattle, Washington, United States, 98109-1023
      • Pfizer Investigational Site
    • Seattle, Washington, United States, 98101
      • Pfizer Investigational Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53792-0001
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically confirmed renal cell carcinoma of clear cell histology with metastases
• Evidence of measurable disease by radiographic technique
• Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1

Exclusion Criteria:

• Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC
• History of or known brain metastases
• Serious acute or chronic illness or recent history of significant cardiac abnormality

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 2	Drug: Interferon-alfa; 3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity; Other Names: Roferon
EXPERIMENTAL: 1	Drug: SU011248; 50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity; Other Names: Sunitinib, SUTENT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS), Core Radiology Assessment	Progression-free survival (PFS) = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS = first event date minus the date of randomization + 1. On study included treatment plus 28-day follow-up periods.	Day 28 of each 6-week cycle: duration of treatment phase
Progression-Free Survival (PFS), Investigator's Assessment	Progression-free survival = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. PFS = first event date minus the date of randomization + 1). On study included treatment plus 28-day follow-up periods.	Day 28 of each 6-week cycle: duration of treatment phase

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response, Core Radiology Assessment	Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. 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. Confirmed responses (CR or PR) = those that persisted on repeat imaging study >= 4 weeks after initial documentation of response.	Day 28 of each 6-week cycle: duration of treatment phase
Objective Response, Investigator's Assessment	Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. 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. Confirmed responses = those that persist on repeat imaging study >= 4 weeks after initial documentation of response.	Day 28 of each 6-week cycle: duration of treatment phase
Overall Survival (OS)	Overall survival (OS) = time from date of randomization to date of death due to any cause. For patients not expiring, survival time was censored at the last date they were known to be alive. Patients lacking data beyond randomization had their survival times censored at the date of randomization with a duration of 1 day.	Clinic visit or telephone contact every 2 months until death
Time to Tumor Progression (TTP), Core Radiology Assessment	TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day.	Randomization to first documentation of tumor progression: duration of treatment phase
Time to Tumor Progression (TTP), Investigator's Assessment	TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than the study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day.	Randomization to first documentation of tumor progression: duration of treatment phase
Duration of Response (DR), Core Radiology Assessement	Duration of response (DR) = time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression.	Day 28 of each cycle: duraton of treatment phase
Duration of Response (DR), Investigator's Assessment	Duration of response (DR) = time from the first documentation of objective tumor response to the first documentaion of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression.	Day 28 of each cycle: duration of treatment phase
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale	FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) subscale of the FKSI to measure advanced kidney cancer disease related symptoms. Includes 9 items: lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria. Each question was answered on a five-point Likert-type scale ranging from 0 (not at all) to 4 (very much). Score = the sum score of the item scores in the subscale; total range: 0 to 36. A score greater than 0 indicates the difference favored sunitinib.	Day 1 & 28 of each cycle: duration of treatment phase
FACT-Kidney Symptom Index (FKSI) Subscale	FACT-Kidney Symptom Index (FKSI) subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions; some questions overlap with the FACT-G questions. Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns).	Day 1 & 28 of each cycle: duration of treatment phase
Functional Assessment of Cancer Therapy-General (FACT-G)	Functional Assessment of Cancer Therapy-General (FACT-G): core questionnaire of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system that has been validated in a variety of cancer populations. 27 questions grouped into 4 domains that measure a patient's physical, functional, social and family, and emotional well-being. Five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = sum score of item scores in the subscale; total range: 0 to 108 with higher score indicating better quality of life.	Day 1 & 28 of each cycle: duration of treatment phase
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale	Physical well-being (PWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates better physical well-being.	Day 1 & 28 of each cycle: duration of treatment phase
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale	Social/family well-being (SWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates less social/family well-being.	Day 1 & 28 of each cycle: duration of treatment phase
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale	Emotional well-being (EWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 24; lower score indicates better emotional well-being.	Day 1 & 28 of each cycle: duration of treatment phase
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale	Functional well-being (FWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; higher score indicates greater functional well-being.	Day 1 & 28 of each cycle: duration of treatment phase
EuroQoL Five Dimension (EQ-5D) Health State Index	EQ-5D Health State Index: a brief, self-administered generic health status instrument. Respondents were asked to describe their current health state on each of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety or depression) on a three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A maximum score of 1 can be derived from these 5 dimensions by score conversion; range: -0.39 (worst health state)to 1.00 (best health state). This descriptive system classifies respondents into one of 243 possible distinct health states (EQ-5D descriptive system).	Day 1 & 28 of each cycle: duration of treatment phase
Euro-QoL Visual Analog Scale (EQ-VAS)	EQ-VAS: overall self-rating rating of the patient's current health state using a 20 cm Visual Analog Scale (EQ-VAS), also called the health state thermometer) is a metric measurement (in 2 mm interval) from the visual analog scale which ranges between 0 (worse imaginable health state) and 100 (best imaginable health state).	Day 1 & 28 of each cycle: duration of treatment phase
Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis	Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter [pg/ml]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.	Day 1 & Day 28, Cycle 1 to Cycle 4
Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis	Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter [pg/ml]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.	Day 1 & Day 28, Cycle 1 to Cycle 4
Incremental Cost Effectiveness Ratio (ICER)	Incremental cost effectiveness ratio (ICER) of sunitinib compared to IFN-a as first-line treatment for MRCC, defined as the ratio of the incremental cost of treatment over the incremental effectiveness; effectiveness measured as quality adjusted life year (QALY) gain. This objective was not addressed in the clinical study report, but an interim analysis of cost-effectiveness was presented separately. These results were not available for inclusion at the time of this posting.	post study measurement
Ctrough Concentrations of SU011248	Subject observed Ctrough (trough drug) concentrations of SU011248 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]).	Day 28 of Cycle 1 to Cycle 4
Ctrough Concentrations of Metabolite SU012662	Subject observed Ctrough (trough drug) concentrations of active metabolite SU012662 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]).	Day 28 of Cycle 1 to Cycle 4
Ctrough Concentrations of SU011248 and Active Metabolite SU012662	Subject observed Ctrough (trough drug) concentrations of total drug (SU011248 and its active metabolite SU012662) per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]).	Day 28 of Cycle 1 to Cycle 4

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Rini BI, Hutson TE, Figlin RA, Lechuga MJ, Valota O, Serfass L, Rosbrook B, Motzer RJ. Sunitinib in Patients With Metastatic Renal Cell Carcinoma: Clinical Outcome According to International Metastatic Renal Cell Carcinoma Database Consortium Risk Group. Clin Genitourin Cancer. 2018 Aug;16(4):298-304. doi: 10.1016/j.clgc.2018.04.005. Epub 2018 May 4.
• de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
• Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
• Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.
• Cella D, Michaelson MD, Bushmakin AG, Cappelleri JC, Charbonneau C, Kim ST, Li JZ, Motzer RJ. Health-related quality of life in patients with metastatic renal cell carcinoma treated with sunitinib vs interferon-alpha in a phase III trial: final results and geographical analysis. Br J Cancer. 2010 Feb 16;102(4):658-64. doi: 10.1038/sj.bjc.6605552. Epub 2010 Jan 26.
• Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):115-24. doi: 10.1056/NEJMoa065044.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (ACTUAL): September 1, 2008
• Study Completion (ACTUAL): September 1, 2008

Study Registration Dates

• First Submitted: June 3, 2004
• First Submitted That Met QC Criteria: June 3, 2004
• First Posted (ESTIMATE): June 4, 2004

Study Record Updates

• Last Update Posted (ESTIMATE): January 26, 2010
• Last Update Submitted That Met QC Criteria: January 19, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Interferons; Interferon-alpha; Sunitinib
• Other Study ID Numbers: A6181034