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

Description

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.

Study Start Date

April 2013

Estimated Completion Date

November 2016

Interventions

  • Drug: Bupropion
  • Drug: LDE225
  • Drug: Wafarin

Specialties

  • Oncology: Pharmacology/Therapy
  • Pharmacy: Chemotherapy/Oncology,Drug Interactions,Drug Trials,Pharmacokinetics

MeSH Terms

  • Bupropion
  • LDE225
  • Neoplasms
  • Wafarin

Study ID

Novartis -- CLDE225A2112

Status

Unknown

Trial ID

NCT01769768

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

100

Sponsor

Novartis

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (13)

Study Location Distance Name Phone Email
Massachusetts General Hospital DanaFarber Cancer Institute - Boston, Massachusetts 2.8 miles None None None
Dartmouth Hitchcock Medical Center DartmouthHitchcock Med Ctr - Lebanon, New Hampshire 105.5 miles None None None
Hackensack University Medical Center Deptof HackensackUnivMedCtr - Hackensack, New Jersey 183.7 miles None None None
University of PennsylvaniaAbramson Cancer Center Abramson Cancer Center - Philadelphia, Pennsylvania 270.8 miles None None None
University of Pittsburgh Cancer Institute UPMC Cancer Pavilion - Pittsburgh, Pennsylvania 477.2 miles None None None
Karmanos Cancer Institute - Detroit, Michigan 611.5 miles None None None
Cancer Centers of the Carolinas SC - Greenville, South Carolina 803.9 miles None None None
Medical University of South Carolina Deptof NeurosciencesMS Ctr - Charleston, South Carolina 821.2 miles None None None
University of Kansas Medical Center CBYM338B2203 - Kansas City, Kansas 1,251.3 miles None None None
University of Colorado Onc Dept - Aurora, Colorado 1,759.8 miles None None None
Cancer Therapy Research Center - San Antonio, Texas 1,768.2 miles None None None
University of Utah Huntsman Cancer Institute - Salt Lake City, Utah 2,094.1 miles None None None
Premiere OncologyPinnacle Oncology Hematology - Santa Monica, California 2,607.9 miles None None None

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