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

Completed · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

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.

Key facts

Study ID

NCT01769768

Run by

Novartis Pharmaceuticals

People needed

114

Starts

2013-04-01

Expected to finish

2016-08-01

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope National Medical Center Oncology — Duarte, California, United States
• University of Kansas Medical Center CBYM338B2203 — Kansas City, Kansas, United States
• Massachusetts General Hospital Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock Med Ctr — Lebanon, New Hampshire, United States
• Hackensack University Medical Center Dept.of HackensackUniv.MedCtr. — Hackensack, New Jersey, United States
• University of Pennsylvania--Abramson Cancer Center Abramson Cancer Center — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Cancer Institute UPMC Cancer Pavilion — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina Dept.of Neurosciences/MS Ctr. — Charleston, South Carolina, United States
• Cancer Centers of the Carolinas SC — Greenville, South Carolina, United States
• Utah Health Science Center at San Antonio — San Antonio, Texas, United States
• University of Utah / Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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