Acute Myeloid LeukemiaPhase 1NCT04827069
A Clinical Trial to Evaluate Clifutinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia(AML)
A Phase 1 study testing Clifutinib Besylate in people with Acute Myeloid Leukemia, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Clifutinib Besylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2018to 30 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented acute myeloid leukemia according to World Health Organization（WHO） criteria(excluding acute promyelocytic leukemia), with FLT3-ITD gene mutation,refractory after common or enhanced chemotherapy or relapse.
- ECOG performance status of 0-1.
- Subjects must have adequate organ function and meeting all of the following laboratory review before enrollment：
- Lood routine examination: WBC≤2000/mm3;
- Liver function: Alanine aminotransferase (ALT) and Aspartate transaminase (AST) ≤2.5×upper limit of normal(ULN); serum bilirubin ≤ 1.5 × ULN;
- Renal function: Serum creatinine ≤ 1.5×ULN, or the creatinine clearance (CrCl)≥ 60 mL / min calculated by the Cockcroft-Gault formula;
- Electrolyte: serum potassium≥3.0mmol/L; serum calcium≥2.0 mmol/L;serum magnesium≥0.5 mmol/L;
- Coagulation function:fibrinogen≥1.0g/L; activated partial thromboplastin time( APTT)≦ULN+10s; prothrombin time(PT)≤ULN+3s.
Who cannot join
- Received FLT3 inhibitors within 4 weeks prior to the administration;
- Received hematopoietic stem cell transplantation within2 months prior to the administration or received immunosuppressor beceause of GVHD;
- Chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks prior to administration;
- Nitrosourea and mitomycin chemotherapy within 6 weeks prior to the administration;
- Have taken live vaccines within 4 weeks prior to /or concurrent with the administration;
- Have received a trial investigational product, or participated in other clinical trials within 4 weeks prior to administration;
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- Documented promyelocytic leukemia (t (15; 17) (q22; q11) and / or promyelocytic leukemia(PML)/retinoic acid receptor alpha (RARa) positivity found in the chromosome, variant acute promyelocytic leukemia;
- With myeloid sarcoma or invasion of central nervous system;
- NCI CTCAE 4.03 ≥ 2 grade of arrhythmia, or corrected QT interval(QTc )> 450 ms ; patients with a history of torsion or congenital QT prolonged syndrome; active infectious disease judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital,College of Medicine,Zhejiang University
Hanzhou
About this study
Official title: A Phase I, Multi-center, Open,Single Arm, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Clifutinib Besylate(HEC73543) in Relapsed or Refractory Acute Myeloid Leukemia (AML)
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.
Read the detailed description
It is a multi-center , open-label, single arm study conducted in 2 parts. Dose-escalation part: Subjects will receive oral Clifutinib Besylate once on C0D1.After 3 days,they will receive Clifutinib Besylate once daily repeatedly until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days.
Expansion part:Expansion cohort might be set to further investigate the safety and efficacy of Clifutinib Besylate at or lower MTD dose recommended by dose-escalation part.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Clifutinib Besylate
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clifutinib BesylateDrug
Also called HEC73543
receive oral Clifutinib Besylate once daily until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Clifutinib Besylate:10 mg Receives: Drug: Clifutinib Besylate |
| Arm 2 | Experimental | Clifutinib Besylate:20 mg Receives: Drug: Clifutinib Besylate |
| Arm 3 | Experimental | Clifutinib Besylate:40 mg Receives: Drug: Clifutinib Besylate |
| Arm 4 | Experimental | Clifutinib Besylate:55 mg Receives: Drug: Clifutinib Besylate |
| Arm 5 | Experimental | Clifutinib Besylate:70 mg Receives: Drug: Clifutinib Besylate |
| Arm 6 | Experimental | Clifutinib Besylate:100 mg Receives: Drug: Clifutinib Besylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Safety and Tolerability assessed through adverse events to determine maximum tolerated dose
Measured: day 1-28
Secondary outcomes (8)
Maximum observed plasma concentration (Cmax)
to assess the pharmacokinetic profile in patients with AML
Measured: On day 1,8,15,22,28
Time of maximum observed plasma concentration (Tmax)
to assess the pharmacokinetic profile in patients with AML
Measured: On day 1,8,15,22,28
Area under the plasma concentration time curve
to assess the pharmacokinetic profile in patients with AML
Measured: On day 1,8,15,22,28
Composite CR rate
CR + CRi +CRMRD-
Measured: up to 18 months
Duration of response
The time from receive CR / CRi/CRMRD-/PR to relapse
Measured: up to 18 months
Objective response rate
CR + CRi +CRMRD- + PR
Measured: up to 18 months
Event Free Survival
From the first time taking experimental drug to treatment failure or progression or relapse or death
Measured: up to 18 months
Overall Survival
From the first time taking experimental drug to death
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start18 May 2018
- Primary completion21 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Arm 1:10 mg Arm 2:20 mg Arm 3:40 mg Arm 4:55 mg Arm 5:70 mg Arm 6: 100 mg
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jie Jin, Doctor, Study chair, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827069
- Sponsor's protocol ID
- PCD-DHEC73543-16-001
- Status last verified
- Sep 2024
- First submitted
- 22 Mar 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-center, Open,Single Arm, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Clifutinib Besylate(HEC73543) in Relapsed or Refractory Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT04827069
- Acronym / sponsor ID
- PCD-DHEC73543-16-001
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 May 2018 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is a multi-center , open-label, single arm study conducted in 2 parts. Dose-escalation part: Subjects will receive oral Clifutinib Besylate once on C0D1.After 3 days,they will receive Clifutinib Besylate once daily repeatedly until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days.
Expansion part:Expansion cohort might be set to further investigate the safety and efficacy of Clifutinib Besylate at or lower MTD dose recommended by dose-escalation part.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Arm 1:10 mg Arm 2:20 mg Arm 3:40 mg Arm 4:55 mg Arm 5:70 mg Arm 6: 100 mg
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Clifutinib BesylateClifutinib Besylate:10 mg |
| Arm 2 | Experimental | Drug: Clifutinib BesylateClifutinib Besylate:20 mg |
| Arm 3 | Experimental | Drug: Clifutinib BesylateClifutinib Besylate:40 mg |
| Arm 4 | Experimental | Drug: Clifutinib BesylateClifutinib Besylate:55 mg |
| Arm 5 | Experimental | Drug: Clifutinib BesylateClifutinib Besylate:70 mg |
| Arm 6 | Experimental | Drug: Clifutinib BesylateClifutinib Besylate:100 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Documented acute myeloid leukemia according to World Health Organization（WHO） criteria(excluding acute promyelocytic leukemia), with FLT3-ITD gene mutation,refractory after common or enhanced chemotherapy or relapse.
- ECOG performance status of 0-1.
- Subjects must have adequate organ function and meeting all of the following laboratory review before enrollment：
Key exclusion criteria (9 listed)
- Received FLT3 inhibitors within 4 weeks prior to the administration;
- Received hematopoietic stem cell transplantation within2 months prior to the administration or received immunosuppressor beceause of GVHD;
- Chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks prior to administration;
- Nitrosourea and mitomycin chemotherapy within 6 weeks prior to the administration;
- Have taken live vaccines within 4 weeks prior to /or concurrent with the administration;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clifutinib BesylateAlso: HEC73543receive oral Clifutinib Besylate once daily until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: day 1-28
Safety and Tolerability assessed through adverse events to determine maximum tolerated dose
8 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: On day 1,8,15,22,28
Time of maximum observed plasma concentration (Tmax)
Time frame: On day 1,8,15,22,28
Area under the plasma concentration time curve
Time frame: On day 1,8,15,22,28
Composite CR rate
Time frame: up to 18 months
Duration of response
Time frame: up to 18 months
Objective response rate
Time frame: up to 18 months
Event Free Survival
Time frame: up to 18 months
Overall Survival
Time frame: up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Jin, Doctor study chair
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clifutinib Besylate in people with Acute Myeloid Leukemia, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: day 1-28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.