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the study aim to assess the effect of INC280 on the pharmacokinetics of digoxin and rosuvastatin in patients with cMET-dysregulated advanced solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INC280 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INC280 | Drug |
| ||
| digoxin |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast of digoxin and rosuvastatin | digoxin and rosuvastatin pharmacokinetics parameters | Up to 240 hours post digoxin and rosuvastatin dose |
| AUCinf of digoxin and rosuvastatin | digoxin and rosuvastatin pharmacokinetics parameters | Up to 240 hours post digoxin and rosuvastatin dose |
| Lambda_z of digoxin and rosuvastatin | digoxin and rosuvastatin pharmacokinetics parameters | Up to 240 hours post digoxin and rosuvastatin dose |
| Cmax of digoxin and rosuvastatin | digoxin and rosuvastatin pharmacokinetics parameters | Up to 240 hours post digoxin and rosuvastatin dose |
| Tmax of digoxin and rosuvastatin | digoxin and rosuvastatin pharmacokinetics parameters | Up to 240 hours post digoxin and rosuvastatin dose |
| T1/2 of digoxin and rosuvastatin | digoxin and rosuvastatin pharmacokinetics parameters | Up to 240 hours post digoxin and rosuvastatin dose |
| CL/F of digoxin and rosuvastatin | digoxin and rosuvastatin pharmacokinetics parameters | Up to 240 hours post digoxin and rosuvastatin dose |
| Vz/F of digoxin and rosuvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events based on the CTCAE v4.03 grade (severity) and other safety data (e.g.,ECG, vital signs, laboratory results) | To assess safety and tolerability of INC280 in patients with cMET-dysregulated advanced solid tumors | From consent to 30 days post last dose |
| Overall response rate of patients treated with INC280 |
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Inclusion Criteria:
Patients must have:
Exclusion Criteria:
Patients must not have:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University School of Medicine/Winship Cancer Institute Phase 1 Working Group | Atlanta | Georgia | 30322 | United States | ||
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| Label | URL |
|---|---|
| Results for CINC280A2105 can be found Novartis Clinical trials results website | View source |
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|
| rosuvastatin | Drug |
|
digoxin and rosuvastatin pharmacokinetics parameters |
| Up to 240 hours post digoxin and rosuvastatin dose |
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 |
| Up to 12 months |
| Disease control rate of patients treated with INC280 | 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 | Up to 12 months |
| Concentration of INC280 during DDI phase | 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. | Day 22, Cycle 2 Day 1 |
| Dartmouth Hitchcock Medical Center |
| Lebanon |
| New Hampshire |
| 03756 |
| United States |
| Novartis Investigative Site | Vienna | A-1090 | Austria |
| Novartis Investigative Site | Edegem | Antwerpen | 2650 | Belgium |
| Novartis Investigative Site | Brno | 65653 | Czechia |
| Novartis Investigative Site | Ioannina | GR | 455 00 | Greece |
| Novartis Investigative Site | Athens | 18547 | Greece |
| Novartis Investigative Site | Milan | MI | 20141 | Italy |
| Novartis Investigative Site | Candiolo | TO | 10060 | Italy |
| Novartis Investigative Site | Bologna | 40138 | Italy |
| Novartis Investigative Site | Naples | 80131 | Italy |
| Novartis Investigative Site | Madrid | 28034 | Spain |
| Novartis Investigative Site | Madrid | 28222 | Spain |
| Novartis Investigative Site | London | W1G 6AD | United Kingdom |
| Novartis Investigative Site | Manchester | M20 9BX | United Kingdom |
| ID | Term |
|---|---|
| C000613976 | capmatinib |
| D004077 | Digoxin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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