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

Last updated on December 7, 2019

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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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Descriptive Information
Brief Title  ICMJE Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma
Official Title  ICMJE 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.
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: Interferon Alfa
  • Experimental: B
    Intervention: Drug: CCI-779
  • Experimental: C
    Intervention: Drug: Interferon Alfa and CCI-779
Publications *


*   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 19, 2007)
626
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion DateJune 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 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
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00065468
Other Study ID Numbers  ICMJE 3066K1-304
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2012

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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