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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 April 2013 |
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Main ID: |
NCT00631371 |
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Date of registration:
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28/02/2008 |
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Primary sponsor: |
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Public title:
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Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects
INTORACT |
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Scientific title:
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Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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791 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00631371 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Argentina
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Australia
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Belgium
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Brazil
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Canada
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Chile
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China
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Colombia
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Croatia
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Czech Republic
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Denmark
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Former Serbia and Montenegro
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France
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Germany
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Hong Kong
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Hungary
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India
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Italy
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Korea, Republic of
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Macau
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Malaysia
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Mexico
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Netherlands
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Poland
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Portugal
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Russian Federation
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Serbia
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Singapore
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Slovakia
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South Africa
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Spain
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Taiwan
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Renal Cell Carcinoma
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Intervention(s)
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Drug: Bevacizumab + Interferon-Alfa
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Drug: Bevacizumab + Temsirolimus
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Primary Outcome(s)
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Independently assessed progression free survival (PFS)
[Time Frame: every 8 weeks]
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Secondary Outcome(s)
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Investigator-assessed progression free survival (PFS), objective response rate
[Time Frame: every 8 weeks]
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Safety
[Time Frame: every 4 weeks]
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Survival
[Time Frame: every 8 weeks]
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Secondary ID(s)
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3066K1-3311
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B1771006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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