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Completed Phase 3 Interventional Results available

Efficacy and Safety of Nilotinib (AMN107) Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib

ClinicalTrials.gov ID: NCT00471328

Public ClinicalTrials.gov record NCT00471328. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 16, 2026, 7:37 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Open-label, Multi-center Study to Evaluate the Efficacy of Nilotinib Versus Best Supportive Care With or Without a Tyrosine Kinase Inhibitor (Investigator's Choice) in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Both Imatinib and Sunitinib

Study identification

NCT ID
NCT00471328
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
248 participants

Conditions and interventions

Interventions

  • Best Supportive Care (BSC) +/- imatinib or sunitinib Other
  • Nilotinib Drug

Other · Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2007
Primary completion
Jul 31, 2008
Completion
May 31, 2011
Last update posted
Jun 11, 2012

2007 – 2011

United States locations

U.S. sites
11
U.S. states
11
U.S. cities
11
Facility City State ZIP Site status
UCLA's Jonsson Comprehensive Cancer Center Los Angeles California 90095
Washington Hospital Center - Washington Cancer Institute Washington D.C. District of Columbia 20010-2965
H. Lee Moffitt Cancer Center Tampa Florida 33612
University of Chicago Hospital Chicago Illinois 60637
Dana Farber Cancer Institute Boston Massachusetts 02115
Wayne State University/Wertz Clinical Cancer Center Detroit Michigan 48201
Washington University School of Medicine - Siteman Cancer Center St Louis Missouri 63110
St. Vincent's Comprehensive Cancer Center New York New York 10011
Wake Forest University Health Sciences Winston-Salem North Carolina 27157-1082
Fox Chase Cancer Center Philadelphia Pennsylvania 19111-2497
University of Texas/MD Anderson Cancer Center Houston Texas 77030-4009

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 24 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00471328, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 11, 2012 · Synced May 16, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00471328 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →