PK and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
An Open-label, Parallel Group, Phase I Study to Assess the Pharmacokinetics and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function.
Sponsor: Novartis Pharmaceuticals
Listed as NCT01429337, this PHASE1 trial focuses on Hepatic Impairment and remains completed. Sponsored by Novartis Pharmaceuticals, it has been updated 16 times since 2011, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
16 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE1
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE1
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
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Jun 2021 — Jul 2024 [monthly]
Completed PHASE1
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Jan 2021 — Jun 2021 [monthly]
Completed PHASE1
▶ Show 11 earlier versions
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Dec 2020 — Jan 2021 [monthly]
Completed PHASE1
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Sep 2020 — Dec 2020 [monthly]
Completed PHASE1
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Jun 2020 — Sep 2020 [monthly]
Completed PHASE1
Status: Recruiting → Completed
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May 2020 — Jun 2020 [monthly]
Recruiting PHASE1
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Dec 2019 — May 2020 [monthly]
Recruiting PHASE1
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Sep 2019 — Dec 2019 [monthly]
Recruiting PHASE1
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Jan 2019 — Sep 2019 [monthly]
Recruiting PHASE1
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Jun 2018 — Jan 2019 [monthly]
Recruiting PHASE1
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Sep 2017 — Jun 2018 [monthly]
Recruiting PHASE1
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Feb 2017 — Sep 2017 [monthly]
Recruiting PHASE1
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Jan 2017 — Feb 2017 [monthly]
Recruiting PHASE1
First recorded
Mar 2011
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Novartis Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .