Spots Global Cancer Trial Database for A Phase I, Multi-center, Open Label, Drug-drug Interaction Study to Assess the Effect of Ceritinib on the Pharmacokinetics of Warfarin and Midazolam in Patients With ALK-positive Advanced Tumors
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Trial Identification
Brief Title: A Phase I, Multi-center, Open Label, Drug-drug Interaction Study to Assess the Effect of Ceritinib on the Pharmacokinetics of Warfarin and Midazolam in Patients With ALK-positive Advanced Tumors
Official Title: A Phase I, Multi-center, Open Label, Drug-drug Interaction Study to Assess the Effect of Ceritinib on the Pharmacokinetics of Warfarin and Midazolam Administered as a Two-drug Cocktail in Patients With ALK-positive Advanced Tumors Including Non-small Cell Lung Cancer (NSCLC)
Study ID: NCT02422589
Conditions
Study Description
Brief Summary: The purpose of this study was to evaluate the potential inhibitory effects of ceritinib on the CYP3A4- and CYP2C9-mediated metabolism of the probe drugs midazolam and warfarin, respectively, when administered simultaneously as a cocktail. The results obtained from this drug interaction study would provide guidance that would enable an update to the ceritinib labeling and ouldl help guide recommendations for administration of co-medications in future clinical trials.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Karmanos Cancer Institute Oncology Department, Detroit, Michigan, United States
Henry Ford Hospital SC, Detroit, Michigan, United States
Cancer Therapy & Research Center UT Health Science Center SC-4, San Antonio, Texas, United States
Novartis Investigative Site, Copenhagen, , Denmark
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Rozzano, MI, Italy
Novartis Investigative Site, Modena, MO, Italy
Novartis Investigative Site, Padova, PD, Italy
Novartis Investigative Site, La Coruna, Galicia, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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