A Dose Escalation Study to Assess PK, Safety and Tolerability of INC280 When Taken With Food in cMET Dysregulated Advanced Solid Tumors.

Completed · Phase 1

Conditions studied: cMET Dysegulation Advanced Solid Tumors

In brief

Dose escalation study to assess PK, safety and tolerability of INC280 when taken with food in patients with cMET dysregulated advanced solid tumors.

Key facts

Study ID

NCT02925104

Run by

Novartis Pharmaceuticals

People needed

36

Starts

2016-12-14

Expected to finish

2018-05-16

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Indiana University Simon Cancer Center SC — Indianapolis, Indiana, United States
• Novartis Investigative Site — Salzburg, Austria
• Novartis Investigative Site — Herlev, Denmark
• Novartis Investigative Site — Dresden, Germany
• Novartis Investigative Site — Mainz, Germany
• Novartis Investigative Site — Nijmegen, Netherlands
• Novartis Investigative Site — Málaga, Andalusia, Spain
• Novartis Investigative Site — Santiago de Compostela, Galicia, Spain
• Novartis Investigative Site — Barcelona, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Zaragoza, Spain
• Novartis Investigative Site — Gothenburg, Sweden
• Novartis Investigative Site — Lund, Sweden
• Novartis Investigative Site — Stockholm, Sweden
• Novartis Investigative Site — Uppsala, Sweden
• Novartis Investigative Site — London, United Kingdom
• Novartis Investigative Site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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