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

PHASE1CompletedINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
Advanced Solid Tumor
Interventions
DRUG

LDE225

LDE225 800 mg once daily dosing will begin on Cycle 1 Day 1 of a 28-day cycle.Treatment with LDE225 for both groups will continue until the patient experiences unacceptable toxicity that precludes further treatment, disease progression, withdrawal of consent and/or at the discretion of the investigator.

DRUG

Wafarin

15 mg single dose of warfarin (oral tablet) will be given to patients.

DRUG

Bupropion

75 mg single dose of bupropion(oral tablet, from an immediate release formulation) will be given to patients

Trial Locations (13)

15232

University of Pittsburgh Cancer Institute UPMC Cancer Pavilion, Pittsburgh

19104

University of Pennsylvania--Abramson Cancer Center Abramson Cancer Center, Philadelphia

29425

Medical University of South Carolina Dept.of Neurosciences/MS Ctr., Charleston

29605

Cancer Centers of the Carolinas SC, Greenville

48201

Karmanos Cancer Institute, Detroit

66160

University of Kansas Medical Center CBYM338B2203, Kansas City

78229

Utah Health Science Center at San Antonio, San Antonio

84112

University of Utah / Huntsman Cancer Institute, Salt Lake City

91010

City of Hope National Medical Center Oncology, Duarte

02114

Massachusetts General Hospital Dana-Farber Cancer Institute, Boston

03756

Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock Med Ctr, Lebanon

07601

Hackensack University Medical Center Dept.of HackensackUniv.MedCtr., Hackensack

19111-2497

Fox Chase Cancer Center, Philadelphia

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY