Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma
NCT00065468
Last updated date
ABOUT THIS STUDY
The primary objective of this study is efficacy. The primary efficacy endpoint of this study
is a comparison of the overall survival of subjects treated with CCI-779 [Temsirolimus],
administered intravenously [IV] once weekly and the combination of CCI-779, administered IV
once weekly with Interferon Alfa [IFN alfa] subcutaneously [SC] three times per week [TIW],
compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in
poor-prognosis subjects with advanced RCC.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma, Kidney Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ 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
- This study will be conducted in subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC who have not received prior systemic therapy for their disease,
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Subjects with central nervous system (CNS) metastases
- Prior anticancer therapy for RCC
- Prior investigational therapy/agents within 4 weeks of randomization
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Renal Cell Carcinoma, Kidney NeoplasmsStudy Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma
NCT00065468
- Little Rock, Arkansas
- La Verne, California
- Los Angeles, California
- San Diego, California
- San Francisco, California
- Waterbury, Connecticut
- Boca Raton, Florida
- Miami, Florida
- Chicago, Illinois
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- Hershey, Pennsylvania
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Charleston, South Carolina
- Knoxville, Tennessee
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- Nashville, Tennessee
- Houston, Texas
- Salt Lake City, Utah
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- Brno,
- Prague 5,
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- Patra,
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- Roma, RM
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- Lublin,
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- Port Elizabeth, Eastern Cape
- Johannesburg, Gauteng
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- Taipei, ROC
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- Glasgow, Strathclyde
- Sutton, Surrey
- Nottingham,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma | |||
| Official Title ICMJE | A Phase 3, Three-Arm, Randomized, Open-Label Study Of Interferon Alfa Alone, CCI-779 Alone, And The Combination Of Interferon Alfa And CCI-779 In First-Line Poor-Prognosis Subjects With Advanced Renal Cell Carcinoma. | |||
| Brief Summary | The primary objective of this study is efficacy. The primary efficacy endpoint of this study is a comparison of the overall survival of subjects treated with CCI-779 [Temsirolimus], administered intravenously [IV] once weekly and the combination of CCI-779, administered IV once weekly with Interferon Alfa [IFN alfa] subcutaneously [SC] three times per week [TIW], compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced RCC. | |||
| 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 |
| |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
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| 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 | 626 | |||
| Original Enrollment ICMJE | Not Provided | |||
| Actual Study Completion Date ICMJE | March 2011 | |||
| Actual Primary Completion Date | June 2006 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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, Canada, Czech Republic, Former Serbia and Montenegro, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Mexico, Netherlands, Poland, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00065468 | |||
| Other Study ID Numbers ICMJE | 3066K1-304 | |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | September 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||