Clinical trial · Interventional
Phase I Study to Evaluate the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients
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
NCT01769768CI-TRIAL-00048947completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bupropion | Drug | — | UNRESOLVED |
| LDE225 | Drug | Sonidegib | ALIAS |
| Wafarin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LDE225+Warfarin
- description
- At least 15 evaluable patients with advanced solid tumors will be enrolled into the study into the warfarin group.
- interventionNames
- Drug: LDE225
- Drug: Wafarin
- type
- EXPERIMENTAL
- label
- LDE225+Bupropion
- description
- At least 15 evaluable patients with advanced solid tumors will be enrolled into the study into the Bupropion group
- interventionNames
- Drug: LDE225
- Drug: Bupropion
Primary outcomes (6)
- measure
- Pharmacokinetics (PK) parameter AUClast for S- and R-warfarin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPooler 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. PMID 32736411