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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumor

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetics (PK) parameter AUClast for S- and R-warfarin

Outcome Description:

Pharmacokinetics of warfarin : Maximum observed plasma concentration after drug administration

Outcome Time Frame:

7 days

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLDE225A2112

NCT ID:

NCT01769768

Start Date:

April 2013

Completion Date:

September 2014

Related Keywords:

  • Advanced Solid Tumor
  • Adults, Hh (Hedgehog) pathway inhibitor, LDE225, Warfarin, Bupropion, advanced solid tumor, drug-drug interaction, pharmacokinetic
  • Neoplasms

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Cancer Therapy & Research CenterSan Antonio, Texas  78229
Karmanos Cancer InstituteDetroit, Michigan  48201
University of Utah / Huntsman Cancer InstituteSalt Lake City, Utah  84103
Massachusetts General Hospital Dana-Farber Cancer InstituteBoston, Massachusetts  02114
University of Pennsylvania--Abramson Cancer Center Abramson Cancer CenterPhiladelphia, Pennsylvania  19104
Medical University of South Carolina Dept.of Neurosciences/MS Ctr.Charleston, South Carolina  29425