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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00083889




Registration number
NCT00083889
Ethics application status
Date submitted
3/06/2004
Date registered
4/06/2004
Date last updated
26/01/2010

Titles & IDs
Public title
SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Scientific title
A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Secondary ID [1] 0 0
A6181034
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Renal Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Interferon-alfa
Treatment: Drugs - SU011248

Active Comparator: 2 -

Experimental: 1 -


Treatment: Drugs: 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

Treatment: Drugs: SU011248
50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS), Core Radiology Assessment
Timepoint [1] 0 0
Day 28 of each 6-week cycle: duration of treatment phase
Primary outcome [2] 0 0
Progression-Free Survival (PFS), Investigator's Assessment
Timepoint [2] 0 0
Day 28 of each 6-week cycle: duration of treatment phase
Secondary outcome [1] 0 0
Objective Response, Core Radiology Assessment
Timepoint [1] 0 0
Day 28 of each 6-week cycle: duration of treatment phase
Secondary outcome [2] 0 0
Objective Response, Investigator's Assessment
Timepoint [2] 0 0
Day 28 of each 6-week cycle: duration of treatment phase
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Clinic visit or telephone contact every 2 months until death
Secondary outcome [4] 0 0
Time to Tumor Progression (TTP), Core Radiology Assessment
Timepoint [4] 0 0
Randomization to first documentation of tumor progression: duration of treatment phase
Secondary outcome [5] 0 0
Time to Tumor Progression (TTP), Investigator's Assessment
Timepoint [5] 0 0
Randomization to first documentation of tumor progression: duration of treatment phase
Secondary outcome [6] 0 0
Duration of Response (DR), Core Radiology Assessement
Timepoint [6] 0 0
Day 28 of each cycle: duraton of treatment phase
Secondary outcome [7] 0 0
Duration of Response (DR), Investigator's Assessment
Timepoint [7] 0 0
Day 28 of each cycle: duration of treatment phase
Secondary outcome [8] 0 0
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale
Timepoint [8] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [9] 0 0
FACT-Kidney Symptom Index (FKSI) Subscale
Timepoint [9] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [10] 0 0
Functional Assessment of Cancer Therapy-General (FACT-G)
Timepoint [10] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [11] 0 0
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale
Timepoint [11] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [12] 0 0
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale
Timepoint [12] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [13] 0 0
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale
Timepoint [13] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [14] 0 0
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale
Timepoint [14] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [15] 0 0
EuroQoL Five Dimension (EQ-5D) Health State Index
Timepoint [15] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [16] 0 0
Euro-QoL Visual Analog Scale (EQ-VAS)
Timepoint [16] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [17] 0 0
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
Timepoint [17] 0 0
Day 1 & Day 28, Cycle 1 to Cycle 4
Secondary outcome [18] 0 0
Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis
Timepoint [18] 0 0
Day 1 & Day 28, Cycle 1 to Cycle 4
Secondary outcome [19] 0 0
Incremental Cost Effectiveness Ratio (ICER)
Timepoint [19] 0 0
post study measurement
Secondary outcome [20] 0 0
Ctrough Concentrations of SU011248
Timepoint [20] 0 0
Day 28 of Cycle 1 to Cycle 4
Secondary outcome [21] 0 0
Ctrough Concentrations of Metabolite SU012662
Timepoint [21] 0 0
Day 28 of Cycle 1 to Cycle 4
Secondary outcome [22] 0 0
Ctrough Concentrations of SU011248 and Active Metabolite SU012662
Timepoint [22] 0 0
Day 28 of Cycle 1 to Cycle 4

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Lismore
Recruitment hospital [2] 0 0
Pfizer Investigational Site - St. Leonards
Recruitment hospital [3] 0 0
Pfizer Investigational Site - South Brisbane
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Woodville South
Recruitment hospital [5] 0 0
Pfizer Investigational Site - East Melbourne
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Perth
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Victoria
Recruitment postcode(s) [1] 0 0
2480 - Lismore
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment postcode(s) [7] 0 0
36184 - Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
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State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Mississippi
Country [15] 0 0
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Missouri
Country [16] 0 0
United States of America
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Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
New Hampshire
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
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State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
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Tennessee
Country [24] 0 0
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Texas
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Utah
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Washington
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Wisconsin
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Brazil
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RJ
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RS
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Alberta
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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France
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Cedex 15
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France
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Lyon
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France
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Paris Cedex 13
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France
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Rennes
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France
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Saint Herblain
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France
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Vandoeuvre Les Nancy
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Germany
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Aachen
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Germany
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Essen
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Germany
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Hannover
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Germany
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Ulm
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Italy
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Modena
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Italy
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Napoli
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Italy
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Pavia
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Italy
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Roma
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Poland
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Warszawa
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Gdansk
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Krakow
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Lodz
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Lublin
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Poznan
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Poland
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Wroclaw
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Russian Federation
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Kaluga Region
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Russian Federation
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Chelyabinsk
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Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Spain
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Barcelona
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Navarra
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Spain
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Madrid
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Spain
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Sevilla
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United Kingdom
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Cardiff
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United Kingdom
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Lancashire
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United Kingdom
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Middlesex
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London
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United Kingdom
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Sutton Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/show/NCT00083889
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications