Acute Myeloid Leukemia (AML)Phase 1NCT04402723
Combination of Donafenib and Cytarabine/Daunorubicin in Relapsed AML
A Phase 1 study testing Donafenib in people with Acute Myeloid Leukemia (AML), run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This phase Ⅰ study of Donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess safety and pharmacokinetics in patients with Relapsed AML. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Donafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2018to 9 Feb 2022
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with diagnosed AML (except APL) according to the FAB and WHO classification, including AML evolving from MDS or other hematologic diseases and AML after previous cytotoxic therapy or radiation (secondary AML) .
- Patients with diagnosed Relapsed AML according to Chinese Guidelines for the Diagnosis and Treatment of Acute Myeloid Leukemia.
- relapse after 6 months of an morphological remission.
- Age ≥ 18 and ≤ 55 years.
- BMI ≥ 18 and ≤27.
- Informed consent, personally signed and dated to participate in the study.
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- ECOG performance status of 0-1.
- Life expectancy of at least 12 weeks.
- Total serum bilirubin ≤1.5×ULN.
- Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 2.5×ULN.
- Serum creatinine ≤1.5×ULN.
- glomerular filtration rate ≥60 mL/min, as calculated with the Cockcroft-Gault formula.
- alkaline phosphatase ≤1.5×ULN.
- urine protein ≤1+, or Urine protein was quantified for 24h ≤0.5g.
- INR/PTT <1.5×ULN.
Who cannot join
- Patients who are not eligible for standard chemotherapy as per discretion of the treating physician.
- Patients who have been treated with bone marrow transplantation.
- Central nervous system manifestation of AML.
- Cardiac disease: heart failure NYHA III or IV; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
- Patients who have thrombosis events within 6 months prior to study entry is permitted.
- Pregnancy or breastfeed.
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- Chronic pulmonary disease with relevant hypoxia.
- Patients undergoing dialysis.
- Known HIV and/or hepatitis C infection.
- Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy.
- Evidence or recent history of CNS disease, including primary or metastatic brain tumors, seizure disorders.
- Blood pressure (BP) higher than systolic 140 mmHg and/or diastolic 90 mmHg after best treatment.
- Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance of the protocol.
- Patients with major surgery, open biopsy or significant traumatic injury within 4 weeks prior to study entry is permitted.
- Serious, non-healing wound, ulcer or bone fracture.
- Infection need antibiotic treatment.
- Cumulative therapeutic dose of Daunorubicin more than 300mg/m2.
- Concurrent malignancies other than AML.
- History of organ allograft.
- Allergy to study medication or excipients in study medication.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology and Blood Disease Hospital
Tianjin, Tianjin Municipality, 300020
About this study
Official title: A Dose-escalated Phase Ⅰ Trial to Assess the Tolerance and Pharmacokinetics of Combination of Donafenib and Cytarabine/Daunorubicin in Relapsed AML Patient
This phase Ⅰ study of Donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess safety and pharmacokinetics in patients with Relapsed AML.
Read the detailed description
Donafenib is a multikinase inhibitor which is acting on various cellular pathways involved in the genesis of acute myeloid leukemia (AML). Donafenib is therefore a promising candidate for improvement of chemotherapy results in AML. This clinical trial evaluates the safety and pharmacokinetics of Donafenib combination with Cytarabine/Daunorubicin for AML in patients between 18 and 55 years of age.
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- Donafenib
- 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.
DonafenibDrug
Also called Cytarabine and Daunorubicin
In first 28-days-cycle, eligible subjects will be given Donafenib 0.2/0.3g, bid, for first 14 days, combination with Daunorubicin 60mg/m2/d, for first 3 days, and Cytarabine 100mg/m2/d, for first 7 days. If CR or CRi is observed, subjects will be given Donafenib 0.2/0.3g, bid, for first 14 days, combination Cytarabine 2g/m2/q12h, for first 3 days, in next 28-day-cycle.
| Study group | Role | What they receive |
|---|---|---|
| Donafenib, 0.2g | Experimental | Donafenib,0.2g,bid,Combination with Cytarabine and Daunorubicin. Receives: Drug: Donafenib |
| Donafenib,0.3g | Experimental | Donafenib,0.3g,bid,Combination with Cytarabine and Daunorubicin Receives: Drug: Donafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety(including the type, severity and frequency of AE)
Safety of combination of donafenib with Cytarabine/Daunorubicin in relapsed AML patients.
Measured: through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start6 Nov 2018
- Primary completion9 Feb 2022
- Study completion9 Feb 2022
Why it stopped: Corporate policy adjustments
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe 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
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianxiang Wang, Doctor, Principal investigator, Institute of Hematology and Blood Disease Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402723
- Sponsor's protocol ID
- ZGDAML1
- Status last verified
- Nov 2022
- First submitted
- 18 May 2020
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-escalated Phase Ⅰ Trial to Assess the Tolerance and Pharmacokinetics of Combination of Donafenib and Cytarabine/Daunorubicin in Relapsed AML Patient
- ClinicalTrials.gov ID
- NCT04402723
- Acronym / sponsor ID
- ZGDAML1
- Conditions
- Acute Myeloid Leukemia (AML)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Corporate policy adjustments
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 9 Feb 2022 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 27 May 2020 (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.
This phase Ⅰ study of Donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess safety and pharmacokinetics in patients with Relapsed AML.
Detailed description
Donafenib is a multikinase inhibitor which is acting on various cellular pathways involved in the genesis of acute myeloid leukemia (AML). Donafenib is therefore a promising candidate for improvement of chemotherapy results in AML. This clinical trial evaluates the safety and pharmacokinetics of Donafenib combination with Cytarabine/Daunorubicin for AML in patients between 18 and 55 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donafenib, 0.2g | Experimental | Drug: DonafenibDonafenib,0.2g,bid,Combination with Cytarabine and Daunorubicin. |
| Donafenib,0.3g | Experimental | Drug: DonafenibDonafenib,0.3g,bid,Combination with Cytarabine and Daunorubicin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Patients with diagnosed AML (except APL) according to the FAB and WHO classification, including AML evolving from MDS or other hematologic diseases and AML after previous cytotoxic therapy or radiation (secondary AML) .
- Patients with diagnosed Relapsed AML according to Chinese Guidelines for the Diagnosis and Treatment of Acute Myeloid Leukemia.
- relapse after 6 months of an morphological remission.
- Age ≥ 18 and ≤ 55 years.
- BMI ≥ 18 and ≤27.
Key exclusion criteria (20 listed)
- Patients who are not eligible for standard chemotherapy as per discretion of the treating physician.
- Patients who have been treated with bone marrow transplantation.
- Central nervous system manifestation of AML.
- Cardiac disease: heart failure NYHA III or IV; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
- Patients who have thrombosis events within 6 months prior to study entry is permitted.
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 |
|---|---|---|
| DonafenibAlso: Cytarabine and DaunorubicinIn first 28-days-cycle, eligible subjects will be given Donafenib 0.2/0.3g, bid, for first 14 days, combination with Daunorubicin 60mg/m2/d, for first 3 days, and Cytarabine 100mg/m2/d, for first 7 days. If CR or CRi is observed, subjects will be given Donafenib 0.2/0.3g, bid, for first 14 days, combination Cytarabine 2g/m2/q12h, for first 3 days, in next 28-day-cycle. | Drug | Donafenib, 0.2g, Donafenib,0.3g |
Primary outcome
Safety(including the type, severity and frequency of AE)
Time frame: through study completion, an average of 2 months
Safety of combination of donafenib with Cytarabine/Daunorubicin in relapsed AML patients.
Results and safety
The study was stopped early (reason given: Corporate policy adjustments). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
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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.
Jianxiang Wang, Doctor principal investigator
Institute of Hematology and Blood Disease Hospital
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 Donafenib in people with Acute Myeloid Leukemia (AML), run by Suzhou Zelgen Biopharmaceuticals 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 15 inclusion and 20 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: stopped early, as of the sponsor's last update on 1 Dec 2022. 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 was stopped early (reason given: Corporate policy adjustments). Results are not available in the source record.
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?
Safety(including the type, severity and frequency of AE) (time frame: through study completion, an average of 2 months). 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 1 Dec 2022.