Spots Global Cancer Trial Database for Safety of TKI258 in Advanced/Metastatic Melanoma Subjects
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Trial Identification
Brief Title: Safety of TKI258 in Advanced/Metastatic Melanoma Subjects
Official Title: A Phase I/II Dose Escalating Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of TKI258 (CHIR-258) in Patients With Locally Advanced or Metastatic Melanoma
Study ID: NCT00303251
Conditions
Interventions
Study Description
Brief Summary: This study is an open-label, dose-escalating study to delineate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TKI258. Pharmacokinetics and pharmacodynamics will be performed on all subjects. The eligible subject population consists of subjects who have been diagnosed with locally advanced or metastatic melanoma that is refractory to standard therapy or for which no curative standard therapy exists.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
James Graham Brown Cancer Center, Louisville, Kentucky, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
MD Anderson Cancer, Houston, Texas, United States
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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