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COMPLETED Phase 2

Efficacy and Safety Comparison of RAD001 Versus Sunitinib in the First-line and Second-line Treatment of Patients With Metastatic Renal Cell Carcinoma

NCT00903175 · View on ClinicalTrials.gov ↗

Study Summary

This study assessed the efficacy and safety of first-line RAD001 followed by second-line sunitinib versus the opposite sequence: first-line sunitinib followed by second-line RAD001 for the treatment of patients with MRCC.

Conditions Studied

Interventions

  • DRUG everolimus
  • DRUG sunitinib

Study Locations (20)

Florida

  • Lynn Cancer Institute — Boca Raton
  • University of Miami SC — Miami
  • MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando — Orlando

Georgia

  • University Cancer & Blood Center, LLC Dept of NE GCC (2) — Athens
  • Georgia Health Sciences University Dept. of MCG — Augusta
  • Summit Cancer Care — Savannah

Alabama

  • University of Alabama at Birmingham/ Kirklin Clinic Comprehensive CancerCenter (1) — Birmingham
  • University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst. — Mobile

California

  • University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (5) — La Jolla
  • University of California at Los Angeles Dept. of UCLA (3) — Los Angeles

Illinois

  • NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Dept.ofNorthwesternMemHospital — Chicago
  • Loyola University Medical Center /Cardinal Bernardin Cancer Cardinal Bernardin Cancer (3) — Maywood

Maryland

  • VA Maryland Health Care Dept.of GreenbaumCancerCent(7) — Baltimore
  • Weinberg Cancer Institute at Franklin Square Hospital — Baltimore

Arkansas

  • Highlands Oncology Group HighlandsOncGrp-Bentonville(2) — Fayetteville

Colorado

  • University of Colorado Dept. of Anschutz Cancer (2) — Aurora

Trial Details

FieldValue
Enrollment Target 471 participants
Start Date 2009-10
Est. Completion 2015-05
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00903175

The ClinicalTrials.gov registry entry for NCT00903175 describes a study currently listed as completed. It is categorized as Phase 2, 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 471 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 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 everolimus 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: NCT00903175 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, Georgia, Alabama. 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 NCT00903175 about?

NCT00903175 is a clinical study titled "Efficacy and Safety Comparison of RAD001 Versus Sunitinib in the First-line and Second-line Treatment of Patients With Metastatic Renal Cell Carcinoma". This study assessed the efficacy and safety of first-line RAD001 followed by second-line sunitinib versus the opposite sequence: first-line sunitinib followed by second-line RAD001 for the treatment of patients with MRCC.

What is the current status of trial NCT00903175?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 471 participants. The study started on 2009-10. Estimated completion is 2015-05.

What conditions does trial NCT00903175 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 NCT00903175?

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

Who is sponsoring clinical trial NCT00903175?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00903175 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. 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