Phase I Study to Evaluate the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients
| Status: | Recruiting | 
|---|---|
| Conditions: | Cancer | 
| Therapuetic Areas: | Oncology | 
| Healthy: | No | 
| Age Range: | 18 - Any | 
| Updated: | 4/21/2016 | 
| Start Date: | April 2013 | 
| End Date: | November 2016 | 
| Contact: | Novartis Pharmaceuticals | 
| Phone: | 1-888-669-6682 | 
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
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.
			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.
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 or patients with locally advanced or metastatic basal cell
carcinoma who are not amendable or eligible for standard therapy.
- 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
We found this trial at
    15
    sites
	
								Aurora, Colorado 80045			
	
			
					Principal Investigator: Karl Lewis
			
						
										Phone: 720-848-0664
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								Boston, Massachusetts 			
	
			
					Principal Investigator: Geoffrey Shapiro
			
						
										Phone: 617-632-4936
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								Charleston, South Carolina 29425			
	
			
					Principal Investigator: Carolyn Britten
			
						
										Phone: 843-792-4271
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								Detroit, Michigan 48201			
	
			
					Principal Investigator: Patricia M. LoRusso
			
						
										Phone: 313-576-8749
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								Duarte, California 91010			
	
			
					Principal Investigator: Vincent Chung
			
						
										Phone: 626-256-4673 extension 63087
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								Greenville, South Carolina 29605			
	
			
					Principal Investigator: Mark A O'Rourke
			
						
										Phone: 864-987-7000
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								Hackensack, New Jersey 07601			
	
			
					Principal Investigator: Martin E. Gutierrez
			
						
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								Kansas City, Kansas 66160			
	
			
					Principal Investigator: Raymond Perez
			
						
										Phone: 913-588-5095
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								Lebanon, New Hampshire 03756			
	
			
					Principal Investigator: Lionel Lewis
			
						
										Phone: 603-650-4828
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								Philadelphia, Pennsylvania 19104			
	
			
					Principal Investigator: Ravi Amaravadi
			
						
										Phone: 001 215 796 5159
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								Philadelphia, Pennsylvania 19111			
	
			
					Principal Investigator: Anthony Olszanski
			
						
										Phone: 215-728-5534
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								Pittsburgh, Pennsylvania 15232			
	
			
					Principal Investigator: Hussein Tawbi
			
						
										Phone: 412-623-2600
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								Salt Lake City, Utah 84112			
	
			
					Principal Investigator: Sunil Sharma
			
						
										Phone: 801-581-5062
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								San Antonio, Texas 78229			
	
			
					Principal Investigator: John Sarantopoulos
			
						
										Phone: 210-616-5069
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								Santa Monica, California 90404			
	
			
					Principal Investigator: Lee Rosen
			
						
										Phone: 310-633-8400
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