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
Title
- Brief Title: 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
- Official Title: A Phase I, Multicenter, Open-label, Single-sequence Drug-drug Interaction Study to Assess the Effect of INC280 on the Pharmacokinetics of Digoxin and Rosuvastatin in Patients With cMET-dysregulated Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
CINC280A2105
- NCT ID:
NCT02626234
Conditions
- cMET-dysregulated Advanced Solid Tumors
Interventions
Drug | Synonyms | Arms |
---|
INC280 | | INC280 |
digoxin | | INC280 |
rosuvastatin | | INC280 |
Purpose
the study aim to assess the effect of INC280 on the pharmacokinetics of digoxin and
rosuvastatin in patients with cMET-dysregulated advanced solid tumors
Trial Arms
Name | Type | Description | Interventions |
---|
INC280 | Experimental | | - INC280
- digoxin
- rosuvastatin
|
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
- 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | AUClast of digoxin and rosuvastatin |
Time Frame: | Up to 240 hours post digoxin and rosuvastatin dose |
Safety Issue: | |
Description: | digoxin and rosuvastatin pharmacokinetics 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: | Up to 12 months |
Safety Issue: | |
Description: | Overall response rate is defined as Complete Response and Partial Response calculated per RECIST 1.1, per investigator assessment from Day 1 until date of progression or death whichever comes first |
Measure: | Disease control rate of patients treated with INC280 |
Time Frame: | Up to 12 months |
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 from Day 1 until date of progression or death whichever comes first |
Measure: | Concentration of INC280 during DDI phase |
Time Frame: | Day 22, Cycle 2 Day 1 |
Safety Issue: | |
Description: | INC280 concentrations collected on Day 22 during DDI phase and Cycle 2 Day 1 during post DDI phase along with a listing of individual values. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Novartis Pharmaceuticals |
Trial Keywords
- cMET, INC280, rosuvastatin, digoxin
Last Updated
December 10, 2020