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NCT00903175 · ClinicalTrials.gov registry record · 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

A Phase 2 study of Renal Cell Carcinoma, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
471
Enrollment target
20
Study locations

NCT00903175: Completed Phase 2 study of Renal Cell Carcinoma, sponsored by Novartis Pharmaceuticals.

NCT00903175 is a Phase 2 study of Renal Cell Carcinoma that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 471 participants, above the 239-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (97% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00903175, a Phase 2 study of Renal Cell Carcinoma, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
471 participants
Enrollment target
20
Study locations

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.

Primary Outcome

PFS\_1L based on investigator assessment of radiology data by RECIST 1.0, was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause during or after first-line treatment with everolimus or sunitinib. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or

Conditions Studied

Renal Cell Carcinoma

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
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT00903175 record still lists

NCT00903175 is an interventional study that assigns participants to a tested intervention. The registered 471 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 (97% higher).

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.

NCT00903175 names 20 study sites across 12 states, led by Florida, Georgia, Alabama.

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.

What interventions are being tested in trial NCT00903175?

The interventions under investigation include: everolimus (DRUG), sunitinib (DRUG).

Who is sponsoring clinical trial NCT00903175?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

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.

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 NCT00903175's enrollment target sits among peer trials

471 18th of 121 higher than 104 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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Related registry views

Source: ClinicalTrials.gov NCT00903175, the US trial registry maintained by the National Library of Medicine. NCT00903175 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.