Phase I Study to Evaluate the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients
NCT ID: NCT01769768
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
114 participants
INTERVENTIONAL
2013-04-30
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LDE225+Warfarin
At least 15 evaluable patients with advanced solid tumors will be enrolled into the study into the warfarin group.
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.
Wafarin
15 mg single dose of warfarin (oral tablet) will be given to patients.
LDE225+Bupropion
At least 15 evaluable patients with advanced solid tumors will be enrolled into the study into the Bupropion group
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.
Bupropion
75 mg single dose of bupropion(oral tablet, from an immediate release formulation) will be given to patients
Interventions
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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.
Wafarin
15 mg single dose of warfarin (oral tablet) will be given to patients.
Bupropion
75 mg single dose of bupropion(oral tablet, from an immediate release formulation) will be given to patients
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Countries
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References
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Pooler DB, Ness DB, Sarantopoulos J, Squittieri N, Ravichandran S, Britten CD, Amaravadi RK, Vaishampayan U, LoRusso P, Shapiro GI, Olszanski AJ, Perez R, Gutierrez M, O'Rourke MA, Chung V, Lee JJ, Lewis LD. The effect of sonidegib (LDE225) on the pharmacokinetics of bupropion and warfarin in patients with advanced solid tumours. Br J Clin Pharmacol. 2021 Mar;87(3):1291-1302. doi: 10.1111/bcp.14508. Epub 2020 Aug 20.
Related Links
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Results for CLDE225A2112 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CLDE225A2112
Identifier Type: -
Identifier Source: org_study_id