Clinical trial
Efficacy and Safety of Nilotinib (AMN107) Compared With Current Treatment…
NCT00471328 · Novartis Pharmaceuticals, Industry · Completed
Key facts
| NCT number | NCT00471328 |
|---|---|
| Title | Efficacy and Safety of Nilotinib (AMN107) Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib |
| 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 |
| Acronym | ENEST |
| Lead sponsor | Novartis Pharmaceuticals, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Gastrointestinal Stromal Tumors |
| Intervention type | Drug, Other |
| Interventions | Nilotinib, Best Supportive Care (BSC) +/- imatinib or sunitinib |
| Enrollment | 248 |
| Start date | Mar 1, 2007 |
| Primary completion | Aug 1, 2008 |
| Completion | Jun 1, 2011 |
| First posted | May 9, 2007 |
| Last update posted | Jun 12, 2012 |
| Countries | Australia, Austria, Canada, Czechia, France, Germany, Italy, Netherlands, Poland, South Korea, Spain, Switzerland and 1 more |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: