A DDI Study to Assess the Effect of INC280 on the PK of Midazolam and Caffeine 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: Caffeine

Drug: Midazolam

Study type

Interventional

Funder types

Industry

Identifiers

NCT02520752

CINC280A2103

Details and patient eligibility

About

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

Enrollment

37 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 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