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COMPLETED Phase 3

Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib

NCT00474786 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 512 participants
Start Date 2007-09
Est. Completion 2013-01
Phase Phase 3

Sponsor

Pfizer

769 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00474786

The ClinicalTrials.gov registry entry for NCT00474786 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 512 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00474786 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Maryland, Oklahoma. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00474786?

The interventions under investigation include: Sorafenib (DRUG), temsirolimus (Torisel) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00474786?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial