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
Title
- Brief Title: A DDI Study to Assess the Effect of INC280 on the PK of Midazolam and Caffeine in Patients With cMET-dysregulated Advanced Solid Tumors
- Official Title: A Phase I, Multicenter, Open-label, Single-sequence Drug-drug Interaction Study to Assess the Effect of INC280 on the Pharmacokinetics of Midazolam and Caffeine in Patients With cMET-dysregulated Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
CINC280A2103
- NCT ID:
NCT02520752
Conditions
- cMET-dysregulated Advanced Solid Tumors
Interventions
Drug | Synonyms | Arms |
---|
INC280 | | INC280 |
Midazolam | | INC280 |
Caffeine | | INC280 |
Purpose
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
Trial Arms
Name | Type | Description | Interventions |
---|
INC280 | Experimental | | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | AUClast of midazolam and caffeine |
Time Frame: | Up to 72 hours post midazolam and caffeine dose |
Safety Issue: | |
Description: | midazolam and caffeine pharmacokinetic parameters |
Secondary Outcome Measures
Measure: | Adverse events based on the CTCAE v4.03 grade (severity) and other safety data (e.g.,ECG, vital signs, laboratory results) |
Time Frame: | From consent to 30 days post last dose |
Safety Issue: | |
Description: | To assess safety and tolerability of INC280 in patients with cMET-dysregulated advanced solid tumors |
Measure: | Overall response rate of patients treated with INC280 |
Time Frame: | Baseline, every 6 weeks |
Safety Issue: | |
Description: | Overall response rate is defined as Complete Response and Partial Response calculated per RECIST 1.1, per investigator assessment |
Measure: | Disease control rate of patients treated with INC280 |
Time Frame: | Baseline, every 6 weeks |
Safety Issue: | |
Description: | Disease control rate is defined as calculated as the proportion of patients with best overall response of Complete Response, Partial Response, or Stable Disease calculated per RECIST 1.1, per investigator assessment |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Novartis Pharmaceuticals |
Trial Keywords
- cMET, INC280, caffeine, midazolam
Last Updated
December 10, 2020