NCT01429337 is a Phase 1 clinical trial of Midostaurin in Hepatic Impairment, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT01429337?

NCT01429337 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT01429337?

Interventions in NCT01429337: Midostaurin, Midostaurin.

What condition does NCT01429337 study?

NCT01429337 studies Hepatic Impairment.

Is NCT01429337 still recruiting?

NCT01429337 is currently completed. Last updated 12 May 2021.

Last reviewed 2021-05-12 · How we verify

NCT01429337

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PK and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function

Completed Phase 1 Last updated 12 May 2021

What this trial tests

Phase 1 trial testing Midostaurin in Hepatic Impairment in 43 participants. Completed in 9 May 2020.

Timeline

7 March 2011

Primary endpoint
13 April 2020

9 May 2020

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	43
Start date	7 March 2011
Primary completion	13 April 2020
Estimated completion	9 May 2020
Sites	7 locations across Belgium, Germany, Romania, Lithuania, Bulgaria, United States

Drugs / interventions tested

Midostaurin (MIDOSTAURIN) — full drug profile →
Midostaurin (MIDOSTAURIN) — full drug profile →

Conditions studied

Hepatic Impairment — all drugs for Hepatic Impairment →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 70, any sex, with Hepatic Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this international study was to assess the effect of varying degrees of impaired hepatic function compared to a normal hepatic function (Child-Pugh classification) on the pharmacokinetics and safety of midostaurin.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Natural Products from Actinomycetes Associated with Marine Organisms.
Chen J, Xu L, Zhou Y, Han B. · · 2021 · cited 43× · PMID 34822500 · DOI 10.3390/md19110629
Midostaurin: an emerging treatment for acute myeloid leukemia patients.
Gallogly MM, Lazarus HM. · · 2016 · cited 43× · PMID 27186148 · DOI 10.2147/jbm.s100283

Verify or expand the search:

Other trials of Midostaurin

Trials testing the same drug.

NCT06313437 — Revumenib in Combination With 7+3 + Midostaurin in AML · Phase 1 · recruiting
NCT04982354 — Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia · Phase 1, PHASE2 · withdrawn
NCT05488613 — Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML) · completed
NCT04496999 — HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt. · Phase 1 · terminated
NCT03951961 — Midostaurin in MRD (Minimal Residual Disease) Positive Acute Myeloid Leukemia After Allogeneic Stem Cell Transplantation · Phase 2 · terminated

Other recruiting trials for Hepatic Impairment

Currently open trials in the same condition.

NCT07269301 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function · Phase 1 · recruiting
NCT07219550 — A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) · Phase 1 · recruiting
NCT07144111 — A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib · Phase 1 · recruiting
NCT07023354 — A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
NCT06985615 — A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement · Phase 1 · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01429337 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 12 May 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01429337.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing