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

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NCT00631371

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, 72205 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT00631371
Pfizer
Completed
Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects

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Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects
Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Renal Cell Carcinoma
  • 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
  • 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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
791
April 2015
April 2012   (Final data collection date for primary outcome measure)

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
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,   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
China,   Croatia,   Denmark,   Former Serbia and Montenegro,   Macau
 
NCT00631371
3066K1-3311
B1771006 ( Other Identifier: Alias Study Number )
2007-003793-26 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2016

ICMJE     Data element required by the

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

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