Description:
Drg-drug Interaction (DDI) study to assess the effect of INC280 on the pharmacokinetics of midazolam and caffeine in patients with cMET-dysregulated advanced solid tumors
Drg-drug Interaction (DDI) study to assess the effect of INC280 on the pharmacokinetics of midazolam and caffeine in patients with cMET-dysregulated advanced solid tumors
Completed
Phase 1
NCT ID: NCT02520752
ORG ID: CINC280A2103
cMET-dysregulated Advanced Solid Tumors
Drug | Synonyms | Arms |
---|---|---|
INC280 | INC280 | |
Midazolam | INC280 | |
Caffeine | INC280 |
Drg-drug Interaction (DDI) study to assess the effect of INC280 on the pharmacokinetics of
midazolam and caffeine in patients with cMET-dysregulated advanced solid tumors
Name | Type | Description | Interventions |
---|---|---|---|
INC280 | Experimental | INC280, Midazolam, Caffeine |
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 or to benzodiazepines or
known intolerance and hypersensitivity to caffeine
- 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 ms (male
patients), 460 ms (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 consumed, or are expected to receive or consume
midazolam or caffeine-containing products (e.g., tea, coffee, cola), within 2 days
prior to Day 1 and during the whole duration of the DDI phase (i.e., from Day -2 to
Day 12)
Other protocol-defined inclusion/exclusion criteria may apply
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
AUClast of midazolam and caffeine
AUCinf of midazolam and caffeine
Lambda_z of midazolam and caffeine
Cmax of midazolam and caffeine
Tmax of midazolam and caffeine
T1/2 of midazolam and caffeine
CL/F of midazolam and caffeine
Vz/F of midazolam and caffeine
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
cMET, INC280, caffeine, midazolam