Description:
the study aim to assess the effect of INC280 on the pharmacokinetics of digoxin and rosuvastatin in patients with cMET-dysregulated advanced solid tumors
the study aim to assess the effect of INC280 on the pharmacokinetics of digoxin and rosuvastatin in patients with cMET-dysregulated advanced solid tumors
Completed
Phase 1
NCT ID: NCT02626234
ORG ID: CINC280A2105
cMET-dysregulated Advanced Solid Tumors
Drug | Synonyms | Arms |
---|---|---|
INC280 | INC280 | |
digoxin | INC280 | |
rosuvastatin | INC280 |
the study aim to assess the effect of INC280 on the pharmacokinetics of digoxin and
rosuvastatin in patients with cMET-dysregulated advanced solid tumors
Name | Type | Description | Interventions |
---|---|---|---|
INC280 | Experimental | INC280, digoxin, rosuvastatin |
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.
Other protocol-defined inclusion/exclusion criteria may apply
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
AUClast of digoxin and rosuvastatin
AUCinf of digoxin and rosuvastatin
Lambda_z of digoxin and rosuvastatin
Cmax of digoxin and rosuvastatin
Tmax of digoxin and rosuvastatin
T1/2 of digoxin and rosuvastatin
CL/F of digoxin and rosuvastatin
Vz/F of digoxin and rosuvastatin
Adverse events based on the CTCAE v4.03 grade (severity) and other safety data (e.g.,ECG, vital signs, laboratory results)
Overall response rate of patients treated with INC280
Disease control rate of patients treated with INC280
Concentration of INC280 during DDI phase
cMET, INC280, rosuvastatin, digoxin