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Brief Title: Phase I Study to Evaluate the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients
Official Title: A Phase Ib, Multi-center, Two Parallel Group, Open-label, Drug-drug Interaction Study to Assess the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients With Advanced Solid Tumors
Study ID: NCT01769768
Brief Summary: This is a multi center, open-label study to evaluate the drug-drug interaction of LDE225 on the PK of bupropion and warfarin patients with advanced solid tumors. Subjects will receive 800mg daily of LDE225 and two separate doses of either bupropion or warfarin.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
City of Hope National Medical Center Oncology, Duarte, California, United States
University of Kansas Medical Center CBYM338B2203, Kansas City, Kansas, United States
Massachusetts General Hospital Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock Med Ctr, Lebanon, New Hampshire, United States
Hackensack University Medical Center Dept.of HackensackUniv.MedCtr., Hackensack, New Jersey, United States
University of Pennsylvania--Abramson Cancer Center Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute UPMC Cancer Pavilion, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina Dept.of Neurosciences/MS Ctr., Charleston, South Carolina, United States
Cancer Centers of the Carolinas SC, Greenville, South Carolina, United States
Utah Health Science Center at San Antonio, San Antonio, Texas, United States
University of Utah / Huntsman Cancer Institute, Salt Lake City, Utah, United States
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR