A Drug-drug Interaction (DDI) Study to Assess the Effect of INC280 on the Pharmacokinetics of Digoxin and Rosuvastatin in Patients With cMET-dysregulated Advanced Solid Tumors
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients must have:
advanced solid tumors and have confirmed cMET dysregulation
at least one measurable lesion as defined by RECIST 1.1.
recovered from all toxicities related to prior anti-cancer therapies
adequate organ function
ECOG performance status (PS) of 0 or 1
You may not be if
Patients must not have:
known hypersensitivity to any of the excipients of INC280
prior treatment with cMET or HGF-targeting inhibitor
known hypersensitivity to digoxin or rosuvastatin or its excipients
symptomatic central nervous system (CNS) metastases who are neurologically unstable
presence or history of carcinomatous meningitis
history of another primary malignancy that is currently clinically significant or currently requires active intervention
Clinically significant, uncontrolled heart diseases, including QTcF ≥ 450 msec (male patients), ≥ 460 msec (female patients) on the screening ECG
Thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting INC280
Major surgery within 4 weeks prior to starting INC280
Patients receiving unstable or increasing doses of corticosteroids.
Impairment of GI function or GI disease that may significantly alter the absorption of INC280
Patients who have received, or are expected to receive digoxin or rosuvastatin within 21 days prior to the beginning of the DDI phase (Day 1) and for the duration of the DDI phase.
Clareo Health | A Drug-drug Interaction (DDI) Study to Assess the Effect of INC280 on the Pharmacokinetics of Digoxin and Rosuvastatin in Patients With cMET-dysregulated Advanced Solid Tumors
