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

Completed · Phase 1

Conditions studied: cMET-dysregulated Advanced Solid Tumors

In brief

the study aim to assess the effect of INC280 on the pharmacokinetics of digoxin and rosuvastatin in patients with cMET-dysregulated advanced solid tumors

Key facts

Study ID

NCT02626234

Run by

Novartis Pharmaceuticals

People needed

32

Starts

2015-12-08

Expected to finish

2017-04-28

Last updated by the study team

2020-12-10

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Emory University School of Medicine/Winship Cancer Institute Phase 1 Working Group — Atlanta, Georgia, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Edegem, Antwerpen, Belgium
• Novartis Investigative Site — Brno, Czechia
• Novartis Investigative Site — Ioannina, GR, Greece
• Novartis Investigative Site — Athens, Greece
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Candiolo, TO, Italy
• Novartis Investigative Site — Bologna, Italy
• Novartis Investigative Site — Naples, Italy
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — London, United Kingdom
• Novartis Investigative Site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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