Study Evaluating The Safety, Efficacy & Pharmacokinetics Of Temsirolimus(CCI-779) In Subjects With Advanced Renal Cell Carcinoma
NCT00494091
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- Subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC. The American Joint Committee on Cancer (AJCC) staging and classification criteria will be used.
- 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.
- CNS metastases at screening or history or CNS metastases.
- 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).
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating The Safety, Efficacy & Pharmacokinetics Of Temsirolimus(CCI-779) In Subjects With Advanced Renal Cell Carcinoma | |||
Official Title ICMJE | Phase 2, Non Randomized, Open Label Study Of Temsirolimus (CCI-779) In Subjects With Advanced Renal Cell Carcinoma (RCC) | |||
Brief Summary | This is a study to evaluate the safety, efficacy and pharmacokinetics of temsirolimus in Asian patients with advanced renal cell carcinoma. The trial is only being conducted in Japan, Korea, and China. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Advanced Renal Cell Carcinoma | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* 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 | 82 | |||
Original Enrollment ICMJE | 80 | |||
Actual Study Completion Date ICMJE | March 2012 | |||
Actual Primary Completion Date | May 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 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 | China, Japan, Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00494091 | |||
Other Study ID Numbers ICMJE | 3066K1-2217 B1771002 | |||
Has Data Monitoring Committee | No | |||
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 |
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PRS Account | Pfizer | |||
Verification Date | March 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |