Phase I Study to Evaluate the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients

Status: Recruiting
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01769768 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-229

 

This is a multi center, open-label study to study the drug-drug interaction of LDE225 on the PK of warfarin and bupropion in patients with advanced solid tumors. Subjects will receive 800mg daily of LDE225 and two separate doses of either bupropion or warfarin.

 

Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute

Overall PI:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu

Eligibility Criteria

Inclusion Criteria: - Adults - Patients with cytopathologically or histopathologically confirmed diagnosis of an advanced solid tumor which has progressed despite standard therapy, or for which no standard therapy exists. - Protocol-defined renal , liver and bone marrow function Exclusion Criteria: - CNS (Central Nervous System) tumors as well as history of brain metastases - Systemic anticancer treatment (including biologic therapy/antibodies) within 2 weeks before first dose of study treatment (6 weeks for nitrosourea, mitomycin, and monoclonal antibodies). - Radiation therapy within 4 weeks before first dose - Investigational agents within 4 weeks before start of study therapy - Patients with known allergy/hypersensitivity to warfarin or bupropion and/or related compounds - Patients with a history of/or active bleeding disorders - Patients receiving treatment with vitamin K, Coumadin or other agents containing warfarin and heparin. Heparin flush to maintain patency of a central venous access device is allowed. - Patients receiving treatment with bupropion. - Patients who have neuromuscular disorders that are associated with elevated CK (Creatine phosphokinase) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy). - Known diagnosis of human immunodeficiency virus (HIV), Hepatitis B or C (testing is not mandatory for study entry) - Patients currently receiving systemic corticosteroids Other protocol-defined inclusion/exclusion criteria may apply
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