NCT04827069 is a Phase 1 clinical trial of Clifutinib Besylate in Acute Myeloid Leukemia, sponsored by Sunshine Lake Pharma Co., Ltd..

Who is sponsoring NCT04827069?

NCT04827069 is sponsored by Sunshine Lake Pharma Co., Ltd..

What drugs are being tested in NCT04827069?

Interventions in NCT04827069: Clifutinib Besylate.

What condition does NCT04827069 study?

NCT04827069 studies Acute Myeloid Leukemia.

Is NCT04827069 still recruiting?

NCT04827069 is currently completed. Last updated 19 September 2024.

Last reviewed 2024-09-19 · How we verify

NCT04827069

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

A Clinical Trial to Evaluate Clifutinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia(AML)

Completed Phase 1 Last updated 19 September 2024

What this trial tests

Phase 1 trial testing Clifutinib Besylate in Acute Myeloid Leukemia in 75 participants. Completed in 30 August 2023.

Timeline

18 May 2018

Primary endpoint
21 August 2023

30 August 2023

Quick facts

Lead sponsor	Sunshine Lake Pharma Co., Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	75
Start date	18 May 2018
Primary completion	21 August 2023
Estimated completion	30 August 2023
Sites	1 location across China

Drugs / interventions tested

Clifutinib Besylate

Conditions studied

Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →

Sponsor

Sunshine Lake Pharma Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of Clifutinib Besylate in Relapsed/refractory AML patients with FLT3-ITD mutation.

Publications & conference data

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

Overcoming Resistance: FLT3 Inhibitors Past, Present, Future and the Challenge of Cure.
Capelli D, Menotti D, Fiorentini A, Saraceni F, et al · · 2022 · cited 22× · PMID 36077850 · DOI 10.3390/cancers14174315
Novel molecular mechanisms of FLT3 deregulation: from the acute myeloid leukemia experience to therapeutic insights in acute lymphoblastic leukemia.
Lo Schiavo F, Salvesi C, Jandoubi M, Pirini F, et al · · 2025 · cited 2× · PMID 41126239 · DOI 10.1186/s12943-025-02455-y
Current scenario of allogeneic hematopoietic stem cell transplantation in adult patients with relapsed/refractory acute myeloid leukemia: a narrative review.
Huang F, Yang K, Du J, Xuan L, et al · · 2025 · PMID 41139710 · DOI 10.1007/s00277-025-06693-4
Abstract Book for the 27th Congress of the European Hematology Association
· 2022

Verify or expand the search:

Other trials of Clifutinib Besylate

Trials testing the same drug.

NCT05133882 — A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML · Phase 1, PHASE2 · recruiting

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I · Phase 2 · recruiting
NCT07177079 — High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML · Phase 1 · recruiting
NCT07384715 — First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelod · Phase 1 · recruiting
NCT07107126 — Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes · Phase 1 · recruiting

Other Sunshine Lake Pharma Co., Ltd. trials

Trials by the same sponsor.

NCT07341672 — A Single-center, Randomized, Open-label, Parallel-design Clinical Study to Evaluate the Pharmacokinetic Effects of Itrac · Phase 1 · not yet recruiting
NCT05048368 — Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function · Phase 1 · not yet recruiting
NCT07376200 — Single-ascending Dose Study of HEC-151 Injection · Phase 1 · not yet recruiting
NCT07082842 — Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF · Phase 3 · not yet recruiting
NCT07211165 — Clinical Study on the Mass Balance of Clifutinib · Phase 1 · completed

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 NCT04827069 (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 Sunshine Lake Pharma Co., Ltd.
Last refreshed: 19 September 2024

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/NCT04827069.

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