cMET Dysegulation Advanced Solid Tumors Clinical Trial
Official title:
A Multicenter, Open Label, Phase 1 Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INC280 Tablet Formulation With Food in Patients With cMET Dysregulated Advanced Solid Tumors.
| Verified date | February 2020 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Dose escalation study to assess PK, safety and tolerability of INC280 when taken with food in patients with cMET dysregulated advanced solid tumors.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | May 16, 2018 |
| Est. primary completion date | May 16, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - cMET dysregulated advanced solid tumor - At least one measurable lesion as defined by RECIST 1.1 - Recovered from all toxicities related to prior anti-cancer therapies to grade = 1 - Adequate organ function - ECOG performance status (PS) = 1 Exclusion Criteria: - Prior treatment with crizotinib or any other cMET or HGF inhibitor - Known hypersensitivity to any of the excipients of INC280 - Symptomatic central nervous system (CNS) metastases who are neurologically unstable - Presence or history of a malignant disease other than the study related cancer - Clinically significant, uncontrolled heart diseases - Thoracic radiotherapy to lung fields = 4 weeks prior to starting INC280 or patients who have not recovered from radiotherapy-related toxicities - Major surgery within 4 weeks prior to starting INC280 - Impairment of GI function - Patients receiving unstable or increasing doses of corticosteroids - Patients receiving treatment with any enzyme-inducing anticonvulsant - Pregnant or nursing (lactating) women Other protocol-related inclusion/exclusion criteria may apply |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Novartis Investigative Site | Salzburg | |
| Denmark | Novartis Investigative Site | Herlev | |
| Germany | Novartis Investigative Site | Dresden | |
| Germany | Novartis Investigative Site | Mainz | |
| Netherlands | Novartis Investigative Site | Nijmegen | |
| Spain | Novartis Investigative Site | Barcelona | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Malaga | Andalucia |
| Spain | Novartis Investigative Site | Santiago de Compostela | Galicia |
| Spain | Novartis Investigative Site | Zaragoza | |
| Sweden | Novartis Investigative Site | Goteborg | |
| Sweden | Novartis Investigative Site | Lund | |
| Sweden | Novartis Investigative Site | Stockholm | |
| Sweden | Novartis Investigative Site | Uppsala | |
| United Kingdom | Novartis Investigative Site | London | |
| United Kingdom | Novartis Investigative Site | Manchester | |
| United States | Indiana University Simon Cancer Center SC | Indianapolis | Indiana |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Austria, Denmark, Germany, Netherlands, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Dose limiting toxiticites (DLTs) | During the first 28 days on INC280 treatment; cycle = 21 days | ||
| Primary | Frequency of DLTs | During the first 28 days on INC280 treatment | ||
| Primary | Category of DLTs | During the first 28 days on INC280 treatment | ||
| Primary | AUClast for INC280 | Treatment Cycle 1 Day 1 (C1D1), C1D7, C1D15, C2D1, C3D1 | ||
| Primary | AUCtau for INC280 | C1D1, C1D7, C1D15, C2D1, C3D1 | ||
| Primary | Cmax for INC280 | C1D1, C1D7, C1D15, C2D1, C3D1 | ||
| Primary | Tmax | C1D1, C1D7, C1D15, C2D1, C3D1 | ||
| Secondary | 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 |