Phase I Study to Evaluate the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients
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 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.
Massachusetts General Hospital, Dana-Farber Cancer Institute
Geoffrey Shapiro, MD, PhD,
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute:
Andrew Wolanski, 617-632-6623,
- 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
- 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
- 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
- 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