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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Advanced Solid Tumor

Intervention: LDE225 (Drug); Wafarin (Drug); Bupropion (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Overall contact:
Novartis Pharmaceuticals, Phone: 1-888-669-6682

Summary

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.

Clinical Details

Official title: 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

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

Primary outcome:

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

PK parameter AUClast for bupropion

PK parameter AUCinf for bupropion

PK parameter AUCinf for S- and R-warfarin

PK parameter Cmax for S- and R-warfarin

PK parameters Cmax for bupropion

Secondary outcome:

effects of LDE225 on the pharmacodynamic activity of warfarin

safety of LDE225 when administered alone and concomitantly with either bupropion or warfarin

evaluate the preliminary evidence of anti-tumor activity of LDE225 in patients with advanced solid tumors

assess the effect of LDE225 treatment on cardiac function

effects of LDE225 on the pharmacodynamic activity of warfarin

safety of LDE225 when administered alone and concomitantly with either bupropion or warfarin

safety of LDE225 when administered alone and concomitantly with either bupropion or warfarin

safety of LDE225 when administered alone and concomitantly with either bupropion or warfarin

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 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:

- 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

Locations and Contacts

Novartis Pharmaceuticals, Phone: 1-888-669-6682

City of Hope National Medical Center Oncology, Duarte, California 91010-3000, United States; Recruiting
Phone: 626-256-4673 extension 63087
Vincent Chung, Principal Investigator

Premiere Oncology/Pinnacle Oncology Hematology, Santa Monica, California 90404, United States; Not yet recruiting
Phone: 310-633-8400
Lee Rosen, Principal Investigator

University of Colorado Onc Dept, Aurora, Colorado 80045, United States; Not yet recruiting
Phone: 720-848-0664
Karl Lewis, Principal Investigator

University of Kansas Medical Center CBYM338B2203, Kansas City, Kansas 66160, United States; Recruiting
Phone: 913-588-5095
Raymond Perez, Principal Investigator

Massachusetts General Hospital Dana-Farber Cancer Institute, Boston, Massachusetts 02114, United States; Recruiting
Phone: 617-632-4936
Geoffrey Shapiro, Principal Investigator

Karmanos Cancer Institute, Detroit, Michigan 48201, United States; Recruiting
Phone: 313-576-8749
Patricia M. LoRusso, Principal Investigator

Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock Med Ctr, Lebanon, New Hampshire 03756, United States; Recruiting
Phone: 603-650-4828
Lionel Lewis, Principal Investigator

Hackensack University Medical Center Dept.of HackensackUniv.MedCtr., Hackensack, New Jersey 07601, United States; Recruiting
Martin E. Gutierrez, Principal Investigator

Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111-2497, United States; Recruiting
Phone: 215-728-5534
Anthony Olszanski, Principal Investigator

University of Pennsylvania--Abramson Cancer Center Abramson Cancer Center, Philadelphia, Pennsylvania 19104, United States; Recruiting
Phone: 001 215 796 5159
Ravi Amaravadi, Principal Investigator

University of Pittsburgh Cancer Institute UPMC Cancer Pavilion, Pittsburgh, Pennsylvania 15232, United States; Not yet recruiting
Phone: 412-623-2600
Hussein Tawbi, Principal Investigator

Medical University of South Carolina Dept.of Neurosciences/MS Ctr., Charleston, South Carolina 29425, United States; Recruiting
Phone: 843-792-4271
Carolyn Britten, Principal Investigator

Cancer Centers of the Carolinas SC, Greenville, South Carolina 29605, United States; Recruiting
Phone: 864-987-7000
Mark A O'Rourke, Principal Investigator

Cancer Therapy & Research Center, San Antonio, Texas 78229, United States; Recruiting
Phone: 210-616-5069
John Sarantopoulos, Principal Investigator

University of Utah / Huntsman Cancer Institute, Salt Lake City, Utah 84112, United States; Recruiting
Phone: 801-581-5062
Sunil Sharma, Principal Investigator

Additional Information

Starting date: April 2013
Last updated: May 26, 2015

Page last updated: August 23, 2015

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