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

Last updated on October 4, 2018

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Study Location
Pfizer Investigational Site
Jonesboro, Arkansas, 72401 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00083889
Pfizer
Completed
SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma

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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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Renal Cell
  • 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 Name: Roferon
  • Drug: SU011248
    50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity
    Other Name: Sunitinib, SUTENT
  • Active Comparator: 2
    Intervention: Drug: Interferon-alfa
  • Experimental: 1
    Intervention: Drug: SU011248


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
750
September 2008
September 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Brazil,   Canada,   France,   Germany,   Italy,   Poland,   Russian Federation,   Spain,   United Kingdom,   United States
 
 
NCT00083889
A6181034
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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