Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects

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NCT00631371

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Study Location
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, 72205, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

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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[email protected]

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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 and/or cytologically confirmed to have advanced renal cell carcinoma (RCC)

- Majority component of conventional clear-cell type is mandatory

- At least 1 measurable lesion (per RECIST)

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


- Prior systemic treatment for RCC


- Evidence of current or prior central nervous system (CNS) metastases


- Cardiovascular disease


- Pregnant or nursing women


- Additional criteria applies

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects
Official Title  ICMJE Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma
Brief Summary Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.
Detailed Description Not 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 Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: Bevacizumab
    Bevacizumab 10 mg/kg intravenous (IV) q8wks
    Other Name: Torisel
  • Drug: Temsirolimus
    Temsirolimus 25 mg IV weekly
  • Drug: Bevacizumab
    Bevacizumab 10 mg/kg intravenous (IV) q8wks
  • Drug: Interferon-Alfa 9MU
    Interferon-Alfa 9MU SC TIW
Study Arms  ICMJE
  • Experimental: 1
    Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly
    Interventions:
    • Drug: Bevacizumab
    • Drug: Temsirolimus
  • Active Comparator: 2
    Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW
    Interventions:
    • Drug: Bevacizumab
    • Drug: Interferon-Alfa 9MU
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: February 18, 2013)		791
Original Estimated Enrollment  ICMJE
 (submitted: February 28, 2008)		800
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically and/or cytologically confirmed to have advanced renal cell carcinoma (RCC)
  • Majority component of conventional clear-cell type is mandatory
  • At least 1 measurable lesion (per RECIST)

Exclusion Criteria:

  • Prior systemic treatment for RCC
  • Evidence of current or prior central nervous system (CNS) metastases
  • Cardiovascular disease
  • Pregnant or nursing women
  • Additional criteria applies
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,   Belgium,   Brazil,   Canada,   Chile,   Colombia,   Czech Republic,   France,   Germany,   Hong Kong,   Hungary,   India,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Poland,   Portugal,   Russian Federation,   Serbia,   Singapore,   Slovakia,   South Africa,   Spain,   Taiwan,   Ukraine,   United Kingdom,   United States
Removed Location Countries China,   Croatia,   Denmark,   Former Serbia and Montenegro,   Macau
 
Administrative Information
NCT Number  ICMJE NCT00631371
Other Study ID Numbers  ICMJE 3066K1-3311
B1771006 ( Other Identifier: Alias Study Number )
2007-003793-26 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP