A Dose Escalation Study to Assess PK, Safety and Tolerability of INC280 When Taken With Food in cMET Dysregulated Advanced Solid Tumors.
NCT ID: NCT02925104
Last Updated: 2020-12-19
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
36 participants
INTERVENTIONAL
2016-12-14
2018-05-16
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
Interventions
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INC280
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
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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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
Countries
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References
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Moreno V, Greil R, Yachnin J, Majem M, Wermke M, Arkenau HT, Basque JR, Nidamarthy PK, Kapoor S, Cui X, Giovannini M. Pharmacokinetics and safety of capmatinib with food in patients with MET-dysregulated advanced solid tumors. Clin Ther. 2021 Jun;43(6):1092-1111. doi: 10.1016/j.clinthera.2021.04.006. Epub 2021 May 27.
Related Links
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Results for CINC280A2108 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2016-001829-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CINC280A2108
Identifier Type: -
Identifier Source: org_study_id