Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00474786 · ClinicalTrials.gov registry record · Phase 3
Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib
A Phase 3 study of Renal Cell Carcinoma, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 512
- Enrollment target
- 20
- Study locations
NCT00474786: Completed Phase 3 study of Renal Cell Carcinoma, sponsored by Pfizer.
NCT00474786 is a Phase 3 study of Renal Cell Carcinoma that has completed, run by Pfizer. The registered enrollment target is 512 participants, above the 239-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (114% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00474786, a Phase 3 study of Renal Cell Carcinoma, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 512 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.
Primary Outcome
Interval from date of randomization until documentation of progressive disease (PD) by an independent tumor assessment according to Response Evaluation Criteria in Solid Tumor (RECIST) or death for any reason whichever occurred first.
Conditions Studied
Interventions
- DRUG Sorafenib
- DRUG temsirolimus (Torisel)
Study Locations (20)
California
- Pfizer Investigational Site - Duarte
- Pfizer Investigational Site - La Jolla
- Pfizer Investigational Site - La Jolla
- Pfizer Investigational Site - Los Angeles
- Pfizer Investigational Site - Los Angeles
- Pfizer Investigational Site - Orange
- Pfizer Investigational Site - Riverside
- Pfizer Investigational Site - San Diego
Maryland
- Pfizer Investigational Site - Baltimore
- Pfizer Investigational Site - Bethesda
Oklahoma
- Pfizer Investigational Site - Oklahoma City
- Pfizer Investigational Site - Tulsa
Connecticut
- Pfizer Investigational Site - Meriden
Indiana
- Pfizer Investigational Site - Municie
Kentucky
- Pfizer Investigational Site - Louisville
Louisiana
- Pfizer Investigational Site - Metairie
Mississippi
- Pfizer Investigational Site - Tupelo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 512 participants |
| Start Date | 2007-09 |
| Est. Completion | 2013-01 |
| Phase | Phase 3 |
What the finished NCT00474786 record still lists
NCT00474786 is an interventional study that assigns participants to a tested intervention. The registered 512 participants enrollment target is mid-sized for trials with a published cap, above the 239-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (114% higher).
The record links to 1 condition, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Sorafenib is the first listed.
NCT00474786 names 20 study sites across 11 states, led by California, Maryland, Oklahoma.
Frequently Asked Questions
What is clinical trial NCT00474786 about?
NCT00474786 is a clinical study titled "Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib". This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be adm...
What is the current status of trial NCT00474786?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 512 participants. The study started on 2007-09. Estimated completion is 2013-01.
What conditions does trial NCT00474786 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma.
What interventions are being tested in trial NCT00474786?
The interventions under investigation include: Sorafenib (DRUG), temsirolimus (Torisel) (DRUG).
Who is sponsoring clinical trial NCT00474786?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00474786 being conducted?
This trial has 20 study locations across California, Connecticut, Indiana, Kentucky, Louisiana. 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 NCT00474786's enrollment target sits among peer trials
512 15th of 121 higher than 107 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
-
A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)
RECRUITING · Phase 3
-
Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma
ACTIVE NOT RECRUITING · Phase 3
-
Dynamic Contrast Enhancement Computed Tomography for Evaluating Tumor Perfusion in Patients With Metastatic Renal Cell Carcinoma Receiving Targeted Therapies: Renal Cell Carcinoma (RCC) Scramble
ACTIVE NOT RECRUITING · Phase 3
-
A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer
ACTIVE NOT RECRUITING · Phase 3
-
Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
ACTIVE NOT RECRUITING · Phase 3
-
Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05005403 · 512 participants · Phase 1
Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Other Solid Tumors, Receiving Intravenous (IV) Infusion of Azirkitug (ABBV-514) Alone or in Combination With Budigalimab or Bevacizumab
- NCT05337410 · 512 participants · NA
YES: Innovative Discussion for Engagement, Achievement, and Service
- NCT06096259 · 512 participants · Phase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
- NCT05691244 · 514 participants · Phase 3
Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia