NCT02859948 is a Phase 1 clinical trial of SKLB1028 in Acute Myeloid Leukemia, sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..

Who is sponsoring NCT02859948?

NCT02859948 is sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..

What drugs are being tested in NCT02859948?

Interventions in NCT02859948: SKLB1028.

What condition does NCT02859948 study?

NCT02859948 studies Acute Myeloid Leukemia.

Is NCT02859948 still recruiting?

NCT02859948 is currently status unknown. Last updated 4 August 2016.

Last reviewed 2016-08-04 · How we verify

NCT02859948

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

Phase I Open-Label, Sequential Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SKLB1028 When Administered Daily to Patients With Relapsed or Refractory Acute Myeloid Leukemia

Status unknown Phase 1 Last updated 4 August 2016

What this trial tests

Phase 1 trial testing SKLB1028 in Acute Myeloid Leukemia in 18 participants. Status unknown.

Timeline

1 May 2016

Primary endpoint
1 December 2017

1 January 2018

Quick facts

Lead sponsor	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	1 May 2016
Primary completion	1 December 2017
Estimated completion	1 January 2018
Sites	1 location across China

Drugs / interventions tested

SKLB1028 — full drug profile →

Conditions studied

Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →

Sponsor

CSPC ZhongQi Pharmaceutical Technology 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.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Safety: Incidence of dose limiting toxicity (DLT)and Adverse Event (AE)
Time frame: 28 Days

Sponsor's own description

Patients will receive oral SKLB1028 for 28 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations.

Publications & conference data

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

Small molecules in targeted cancer therapy: advances, challenges, and future perspectives.
Zhong L, Li Y, Xiong L, Wang W, et al · · 2021 · cited 1003× · PMID 34054126 · DOI 10.1038/s41392-021-00572-w
Molecular targeting in acute myeloid leukemia.
Lim SH, Dubielecka PM, Raghunathan VM. · · 2017 · cited 32× · PMID 28851395 · DOI 10.1186/s12967-017-1281-x
Clinical use of FLT3 inhibitors in acute myeloid leukemia.
Sutamtewagul G, Vigil CE. · · 2018 · cited 25× · PMID 30410361 · DOI 10.2147/ott.s171640

Verify or expand the search:

Other trials of SKLB1028

Trials testing the same drug.

NCT05070195 — A Study to Investigate the Drug-drug Interactions (DDIs) Between SKLB1028 and Midazolam in Healthy Subjects · Phase 1 · completed
NCT05109663 — A Dose Escalation and Food Effect Study of SKLB1028 in Healthy Subjects · Phase 1 · completed

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 CSPC ZhongQi Pharmaceutical Technology Co., Ltd. trials

Trials by the same sponsor.

NCT07532655 — A Single Ascending Dose Study of SYH2082 Injection in Healthy Participants · Phase 1 · not yet recruiting
NCT07412353 — A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2085 · Phase 1 · recruiting
NCT07282509 — Safety and Efficacy of Paclitaxel Liposome Arterial Infusion Combined With Systemic Therapy for Second-Line Treatment of · Phase 1, PHASE2 · not yet recruiting
NCT07418736 — A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease · Phase 2 · recruiting
NCT07241936 — A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors · Phase 1, PHASE2 · 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 NCT02859948 (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 CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Last refreshed: 4 August 2016

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/NCT02859948.

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