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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001829-14 | EudraCT Number |
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Dose escalation study to assess PK, safety and tolerability of INC280 when taken with food 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose limiting toxiticites (DLTs) | During the first 28 days on INC280 treatment; cycle = 21 days | |
| Frequency of DLTs | During the first 28 days on INC280 treatment | |
| Category of DLTs | During the first 28 days on INC280 treatment | |
| AUClast for INC280 | Treatment Cycle 1 Day 1 (C1D1), C1D7, C1D15, C2D1, C3D1 | |
| AUCtau for INC280 | C1D1, C1D7, C1D15, C2D1, C3D1 | |
| Cmax for INC280 | C1D1, C1D7, C1D15, C2D1, C3D1 | |
| Tmax | C1D1, C1D7, C1D15, C2D1, C3D1 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events based on CTCAE grading and other safety variables (e.g. EGC readings, physical examination, vital signs and laboratory results). | Screening, until 30 days post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Simon Cancer Center SC | Indianapolis | Indiana | 46202 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34053700 | Derived | Moreno V, Greil R, Yachnin J, Majem M, Wermke M, Arkenau HT, Basque JR, Nidamarthy PK, Kapoor S, Cui X, Giovannini M. Pharmacokinetics and safety of capmatinib with food in patients with MET-dysregulated advanced solid tumors. Clin Ther. 2021 Jun;43(6):1092-1111. doi: 10.1016/j.clinthera.2021.04.006. Epub 2021 May 27. |
| Label | URL |
|---|---|
| Results for CINC280A2108 can be found on the Novartis Clinical Trial Results Website | View source |
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| Salzburg |
| 5020 |
| Austria |
| Novartis Investigative Site | Herlev | 2730 | Denmark |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | Nijmegen | 6500 HB | Netherlands |
| Novartis Investigative Site | Málaga | Andalusia | 29010 | Spain |
| Novartis Investigative Site | Santiago de Compostela | Galicia | 15706 | Spain |
| Novartis Investigative Site | Barcelona | 08041 | Spain |
| Novartis Investigative Site | Madrid | 28040 | Spain |
| Novartis Investigative Site | Zaragoza | 50009 | Spain |
| Novartis Investigative Site | Gothenburg | 413 45 | Sweden |
| Novartis Investigative Site | Lund | SE-221 85 | Sweden |
| Novartis Investigative Site | Stockholm | 171 76 | Sweden |
| Novartis Investigative Site | Uppsala | SE-751 85 | Sweden |
| Novartis Investigative Site | London | W1G 6AD | United Kingdom |
| Novartis Investigative Site | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| C000613976 | capmatinib |
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