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| Tracking Information | |||||
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| First Received Date ICMJE | July 24, 2003 | ||||
| Last Updated Date | December 19, 2007 | ||||
| Start Date ICMJE | March 2001 | ||||
| Estimated Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Overall survival [ Time Frame: Duration of trial ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Overall survival | ||||
| Change History | Complete list of historical versions of study NCT00065468 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| 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, administered IV once weekly and the combination of CCI-779, administered IV once weekly with IFN alfa (SC TIW), compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced RCC. |
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| Detailed Description | 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, administered IV once weekly and the combination of CCI-779, administered IV once weekly with IFN alfa (SC TIW), compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced Renal Cell Carcinoma (RCC). The secondary objectives of this study are safety, health outcomes, and additional efficacy endpoints. The secondary efficacy endpoints of this study are an evaluation of the following endpoints in subjects treated with CCI-779, administered IV once weekly and the combination of CCI-779, administered IV once weekly with IFN alfa (SC TIW), compared with subjects treated with IFN alfa (SC TIW) alone: progression-free survival (PFS), response rate (complete response [CR] and partial response [PR]), clinical benefit rate (CR/PR/stable disease [SD]), the duration of overall response, time to treatment failure (TTF), and health outcomes measurements. In addition, subject responses across all 3 treatment arms will be evaluated based on screening tumor expression of proteins involved in AKT-mTor pathway (i.e., Akt phosphorylation, PTEN expression). This study will evaluate the safety of subjects treated with CCI-779 and CCI-779 given in combination with IFN alfa compared with subjects treated with IFN alfa alone. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, Staroslawska E, Sosman J, McDermott D, Bodrogi I, Kovacevic Z, Lesovoy V, Schmidt-Wolf IG, Barbarash O, Gokmen E, O'Toole T, Lustgarten S, Moore L, Motzer RJ; Global ARCC Trial. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007 May 31;356(22):2271-81. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 626 | ||||
| Estimated Completion Date | June 2008 | ||||
| Estimated Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00065468 | ||||
| Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | ||||
| Study ID Numbers ICMJE | 3066K1-304 | ||||
| Study Sponsor ICMJE | Wyeth | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Wyeth | ||||
| Verification Date | December 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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