A DDI Study to Assess the Effect of INC280 on the PK of Midazolam and Caffeine in Patients With cMET-dysregulated Advanced Solid Tumors
NCT ID: NCT02520752
Last Updated: 2020-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
37 participants
INTERVENTIONAL
2015-12-10
2017-09-12
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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INC280
INC280
Midazolam
Caffeine
Interventions
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INC280
Midazolam
Caffeine
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Countries
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Related Links
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Results for CINC280A2103 can be found on the Novartis Clinical trial results website
Other Identifiers
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CINC280A2103
Identifier Type: -
Identifier Source: org_study_id