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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 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.

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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.

Conditions Studied

Renal Cell Carcinoma

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

1,845 total trials

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What the Registry Record Tells You About NCT00474786

The ClinicalTrials.gov registry entry for NCT00474786 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 512 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 239-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (114% higher). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.