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NCT00353301 · ClinicalTrials.gov registry record · Phase 2
Erlotinib and Sirolimus for the Treatment of Metastatic Renal Cell Carcinoma
A Phase 2 study of Renal Cell Carcinoma, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT00353301: Completed Phase 2 study of Renal Cell Carcinoma, sponsored by University of Colorado, Denver.
NCT00353301 is a Phase 2 study of Renal Cell Carcinoma that has completed, run by University of Colorado, Denver. The registered enrollment target is 25 participants, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00353301, a Phase 2 study of Renal Cell Carcinoma, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to test the safety and efficacy of the combination of erlotinib hydrochloride (Tarceva™) and sirolimus (Rapamune™) in the treatment of patients with metastatic kidney cancer.
Primary Outcome
Time to progression was defined as the time from beginning of therapy until disease progression or death. For subjects who had not progressed at the time of statistical analysis, progression-free survival was censored at the date of their last tumor assessment. Kaplan-Meier method was used to estimate median progression-free survival. Progression was defined as radiographic progression according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (year 2000 version), non-compliance
Conditions Studied
Interventions
- DRUG Sirolimus
- DRUG Erlotinib hydrochloride
Study Locations (1)
Colorado
- University of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2006-07 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
What the finished NCT00353301 record still lists
NCT00353301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Sirolimus is the first listed.
NCT00353301 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT00353301 about?
NCT00353301 is a clinical study titled "Erlotinib and Sirolimus for the Treatment of Metastatic Renal Cell Carcinoma". The purpose of this study is to test the safety and efficacy of the combination of erlotinib hydrochloride (Tarceva™) and sirolimus (Rapamune™) in the treatment of patients with metastatic kidney cancer.
What is the current status of trial NCT00353301?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2006-07. Estimated completion is 2012-03.
What conditions does trial NCT00353301 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma.
What interventions are being tested in trial NCT00353301?
The interventions under investigation include: Sirolimus (DRUG), Erlotinib hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00353301?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00353301 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Renal Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00353301's enrollment target sits among peer trials
25 101st of 121 higher than 19 of 121 other Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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