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

Novartis

Status and phase

Completed

Phase 1

Conditions

cMET-dysregulated Advanced Solid Tumors

Treatments

Drug: INC280

Drug: rosuvastatin

Drug: digoxin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02626234

CINC280A2105

Details and patient eligibility

About

the study aim to assess the effect of INC280 on the pharmacokinetics of digoxin and rosuvastatin in patients with cMET-dysregulated advanced solid tumors

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.