NCT03622541 is a Phase 2 clinical trial of Sorafenib 200mg in FLT3-ITD Mutation, sponsored by The University of Hong Kong.

Who is sponsoring NCT03622541?

NCT03622541 is sponsored by The University of Hong Kong.

What drugs are being tested in NCT03622541?

Interventions in NCT03622541: Sorafenib 200mg.

What condition does NCT03622541 study?

NCT03622541 studies FLT3-ITD Mutation, AML.

Is NCT03622541 still recruiting?

NCT03622541 is currently completed. Last updated 30 March 2020.

Last reviewed 2020-03-30 · How we verify

NCT03622541

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

Using Sorafenib as a Salvage Treatment for Relapsed or Refractory Acute Myeloid Leukemia Carrying FLT3-ITD

Completed Phase 2 Last updated 30 March 2020

What this trial tests

Phase 2 trial testing Sorafenib 200mg in FLT3-ITD Mutation in 46 participants. Completed in 1 March 2020.

Timeline

15 November 2010

Primary endpoint
1 December 2019

1 March 2020

Quick facts

Lead sponsor	The University of Hong Kong
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	46
Start date	15 November 2010
Primary completion	1 December 2019
Estimated completion	1 March 2020
Sites	1 location across Hong Kong

Drugs / interventions tested

Sorafenib 200mg — full drug profile →

Conditions studied

FLT3-ITD Mutation — all drugs for FLT3-ITD Mutation →
AML — all drugs for AML →

Sponsor

The University of Hong Kong

Who can join

18 and older, any sex, with FLT3-ITD Mutation or AML. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with refractory or relapsed acute myeloid leukemia (AML) after two courses of standard chemotherapy regimens have very limited options. Further chemotherapy is associated with significant toxicity and is generally ineffective. About 10-30% patients with AML carry a gain-of-function mutation of a gene known as Flt3 in the leukemic cells, conferring them with abnormal cellular proliferation. Sorafenib is a multi-kinase inhibitor which was licensed in Hong Kong for the treatment of advanced hepatocellular and renal cell carcinoma. The drug has also been shown to be effective against Flt3 and AML but it has not been licensed for use in this condition.

Publications & conference data

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

Therapeutic Targeting of FLT3 in Acute Myeloid Leukemia: Current Status and Novel Approaches.
Tecik M, Adan A. · · 2022 · cited 25× · PMID 36474506 · DOI 10.2147/ott.s384293
Overcoming the sorafenib resistance mechanism in FLT3-mutated acute myeloid leukemia: molecular basis and new targets.
Peng H, Li M, Peng YY, Li XL, et al · · 2025 · PMID 41479777 · DOI 10.3389/fonc.2025.1713174

Verify or expand the search:

Other trials of Sorafenib 200mg

Trials testing the same drug.

NCT02716012 — First-in-Human Safety, Tolerability and Antitumour Activity Study of MTL-CEBPA in Patients With Advanced Liver Cancer · Phase 1 · unknown

Other recruiting trials for FLT3-ITD Mutation

Currently open trials in the same condition.

NCT07463651 — MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib · Phase 3 · recruiting

Other The University of Hong Kong trials

Trials by the same sponsor.

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NCT07448649 — Chatbot-Assisted Advance Care Planning Education for Family Members · NA · not yet recruiting
NCT07484932 — TRTRM (ACTTOP) -Guided Dosing Strategy in Older Patients With Cancer · NA · not yet recruiting
NCT07531589 — BrainLive Connect: Non-professional Delivered CST for People Living With Dementia · NA · 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 NCT03622541 (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 The University of Hong Kong
Last refreshed: 30 March 2020

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/NCT03622541.

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