A DDI Study to Assess the Effect of INC280 on the PK of Midazolam and Caffeine in Patients With cMET-dysregulated Advanced Solid Tumors

Completed · Phase 1

Conditions studied: cMET-dysregulated Advanced Solid Tumors

In brief

Drg-drug Interaction (DDI) study to assess the effect of INC280 on the pharmacokinetics of midazolam and caffeine in patients with cMET-dysregulated advanced solid tumors

Key facts

Study ID

NCT02520752

Run by

Novartis Pharmaceuticals

People needed

37

Starts

2015-12-10

Expected to finish

2017-09-12

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 or to benzodiazepines or known intolerance and hypersensitivity to caffeine
• 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 ms (male patients), ≥ 460 ms (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 consumed, or are expected to receive or consume midazolam or caffeine-containing products (e.g., tea, coffee, cola), within 2 days prior to Day 1 and during the whole duration of the DDI phase (i.e., from Day -2 to Day 12)
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Emory University School of Medicine/Winship Cancer Institute SC-2 — Atlanta, Georgia, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Novartis Investigative Site — Sofia, Bulgaria
• Novartis Investigative Site — Copenhagen, Denmark
• Novartis Investigative Site — Dijon, Cote D Or, France
• Novartis Investigative Site — Pierre-Bénite, France
• Novartis Investigative Site — Rozzano, MI, Italy
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Santiago de Compostela, Galicia, Spain
• Novartis Investigative Site — London, United Kingdom
• Novartis Investigative Site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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