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

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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.


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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Detroit, MI
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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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