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Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Little Rock, Arkansas, 72205 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma, Kidney Neoplasms
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

- This study will be conducted in subjects with histologically confirmed, advanced
(stage IV or recurrent disease) RCC who have not received prior systemic therapy for
their disease,

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

- Subjects with central nervous system (CNS) metastases

- Prior anticancer therapy for RCC

- Prior investigational therapy/agents within 4 weeks of randomization

NCT00065468
Pfizer
Completed
Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma

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Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma
A Phase 3, Three-Arm, Randomized, Open-Label Study Of Interferon Alfa Alone, CCI-779 Alone, And The Combination Of Interferon Alfa And CCI-779 In First-Line Poor-Prognosis Subjects With Advanced Renal Cell Carcinoma.
The primary objective of this study is efficacy. The primary efficacy endpoint of this study is a comparison of the overall survival of subjects treated with CCI-779 [Temsirolimus], administered intravenously [IV] once weekly and the combination of CCI-779, administered IV once weekly with Interferon Alfa [IFN alfa] subcutaneously [SC] three times per week [TIW], compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced RCC.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Drug: Interferon Alfa
    Interferon alfa (Roferon) 3 MU given Sub Cutaneously three time /week for the first week, 9 MU given Sub Cutaneously three time /week for the second week, 18 MU given Sub Cutaneously three time /week thereafter.
  • Drug: CCI-779
    25 mg of CCI-779 given Intra Venously once per week
  • Drug: Interferon Alfa and CCI-779
    15 mg of CCI-779 given Intra Venously once per week; 6 MU of IFN alfa (Roferon) given Sub Cutaneously three time /week
  • Active Comparator: A
    Intervention: Drug: Interferon Alfa
  • Experimental: B
    Intervention: Drug: CCI-779
  • Experimental: C
    Intervention: Drug: Interferon Alfa and CCI-779


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
626
March 2011
June 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • This study will be conducted in subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC who have not received prior systemic therapy for their disease,

Exclusion Criteria:

  • Subjects with central nervous system (CNS) metastases
  • Prior anticancer therapy for RCC
  • Prior investigational therapy/agents within 4 weeks of randomization
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Canada,   Czech Republic,   Former Serbia and Montenegro,   Germany,   Greece,   Hungary,   Italy,   Latvia,   Lithuania,   Mexico,   Netherlands,   Poland,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
 
 
NCT00065468
3066K1-304
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2012

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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[email protected]



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