Study Evaluating The Safety, Efficacy & Pharmacokinetics Of Temsirolimus(CCI-779) In Subjects With Advanced Renal Cell Carcinoma
NCT ID: NCT00494091
Last Updated: 2013-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
82 participants
INTERVENTIONAL
2007-02-28
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A.
Temsirolimus (CCI-779)
20 mg/m2 IV TEMSR weekly (Japan, n=6)
B.
Temsirolimus (CCI-779)
25 mg IV TEMSR weekly (all other pts)
Interventions
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Temsirolimus (CCI-779)
20 mg/m2 IV TEMSR weekly (Japan, n=6)
Temsirolimus (CCI-779)
25 mg IV TEMSR weekly (all other pts)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG performance status of 0-1.
* At least one measurable lesion per RECIST.
* Age greater than or equal to 20 years.
* Japanese, Chinese, or Korean ethnicity.
Exclusion Criteria
* Prior targeted, chemotherapeutic, cytokine-based, or other investigational agents for the treatment of RCC within 4 weeks before first dose of test article. Subjects must have documented objective progressive disease after any prior systemic RCC treatment and have recovered to grade 1 or lower toxicities from effects of prior systemic therapy for RCC.
* In past 5 years, other prior malignancy (except basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ).
20 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Nanjing, Jiangsu, China
Pfizer Investigational Site
Beijing, , China
Pfizer Investigational Site
Beijing, , China
Pfizer Investigational Site
Beijing, , China
Pfizer Investigational Site
Shanghai, , China
Pfizer Investigational Site
Shanghai, , China
Pfizer Investigational Site
Chiba, , Japan
Pfizer Investigational Site
Fukuoka, , Japan
Pfizer Investigational Site
Gunma, , Japan
Pfizer Investigational Site
Hokkaido, , Japan
Pfizer Investigational Site
Ibaraki, , Japan
Pfizer Investigational Site
Kagawa, , Japan
Pfizer Investigational Site
Kagoshima, , Japan
Pfizer Investigational Site
Kyoto, , Japan
Pfizer Investigational Site
Nara, , Japan
Pfizer Investigational Site
Okayama, , Japan
Pfizer Investigational Site
Osaka, , Japan
Pfizer Investigational Site
Shizuoka, , Japan
Pfizer Investigational Site
Tokyo, , Japan
Pfizer Investigational Site
Yamagata, , Japan
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1771002
Identifier Type: -
Identifier Source: secondary_id
3066K1-2217
Identifier Type: -
Identifier Source: org_study_id
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