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Spots Global Cancer Trial Database for Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)

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Trial Identification

Brief Title: Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)

Official Title: A Phase I Multicenter, Dose Escalation Study of AMN107 in Combination With Imatinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant Gastrointestinal Stromal Tumors (GIST)

Study ID: NCT00135005

Interventions

AMN107, STI571

Study Description

Brief Summary: This study is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resistant GIST, and to characterize the safety, tolerability and pharmacokinetic (PK) profile of this combination.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Novartis Investigative Site, Boston, Massachusetts, United States

Novartis Investigative Site, Philadelphia, Pennsylvania, United States

Novartis Investigative Site, Lyon Cedex, , France

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Milano, MI, Italy

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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