Acute Myeloid Leukemia LeukemiaPhase 1/2NCT04946890
A Study of MRX2843 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1/2 study testing MRX2843 in people with Acute Myeloid Leukemia Leukemia, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
Patients will receive oral MRX2843 for 28 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia Leukemia
- What is being tested?
- MRX2843
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 31 Dec 2024
- Phase
- Phase 1/2
- 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
- Males and females age ≥ 18 years;
- Expected survival period ≥ 12 weeks;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Histopathologically documented primary or secondary AML, as defined by WHO criteria, confirmed by pathology review at treating institution, meeting at least one of the following: i. After complete remission, leukemia cells reappear in peripheral blood, or the ratio of bone marrow immature cells to bone marrow cells> 5%, or leukemia cell infiltration outside the bone marrow; ii. After standard protocol (including cytarabine and a kind of Anthracycline or anthraquinone drugs) for refractory AML patients who have not achieved complete remission after two courses of treatment;
- During the dose escalation phase, there is no need to test for FLT3 mutation status; for the expansion of the enrollment and phase II study phase, the FLT3 mutation status test results within the past 6 months will be accepted; if not, the central laboratory or research center needs to test and confirm the test Patients with FLT3 mutation status in bone marrow or whole blood. The test results show that the subject has any of the following FLT3 mutation types, and can be included in the group: FLT3 internal tandem repeat (ITD), FLT3 tyrosine kinase domain (TKD);
- Laboratory inspection must meet the following standards:
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- Blood routine: Under normal circumstances, the white blood cell count (WBC) ≤20×109/L; or the patient's white blood cell count (WBC)>20×109/L before using hydroxyurea or cytarabine, use for a period of time and stop the drug After 3 days, check the white blood cell count (WBC) ≤20×109/L;
- Blood coagulation function: the international standardized ratio of prothrombin time and partial thromboplastin time ≤ 1.5 times the upper limit of normal (ULN);
- Liver: If there is no clear liver metastasis, serum total bilirubin ≤1.5 ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 ULN; if there is clear Gilbert syndrome (Unconjugated hyperbilirubinemia), total bilirubin ≤ 3.0 ULN;
- Kidney: Serum creatinine (Scr) ≤1.5×ULN, or creatinine clearance (Ccr) ≥50 mL/min (calculated according to Cockcroft-Gault formula);
- Normal or abnormal ocular retinal examination has no clinical significance;
Who cannot join
- Previously received medications targeting MerTK and/or FLT3
- Histologic diagnosis of acute promyelocytic leukemia;
- Have had other malignant tumors in the past 5 years ;
- Persistent clinically significant toxicity from prior chemotherapy that is Grade 2 or higher;
- The tumor involves the central nervous system and/or the testis;
- Active, uncontrolled infection;
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- Radiation therapy within 4 weeks prior to study;
- Received systemic glucocorticoids within 14 days before the first dose ；
- Left ventricular ejection fraction ≤1 × ULN,or﹤50%. Clinically significant ECG QTc prolongation (Male: >450ms, Female: >470ms).Significant cardiac disease；
- Human immunodeficiency virus positivity;
- Active hepatitis B or C or other active liver disease;
- Women who are pregnant, lactating;
- Have a history or family history of known or suspected retinitis pigmentosa;
- Inability to swallow drugs orally, and conditions that seriously affect the absorption or pharmacokinetic parameters of the test drug;
- History of type 1 diabetes;
- Any situation that is unstable or may endanger the safety of patients and their compliance with research;
- Medical condition, serious intercurrent illness, or other extenuating circumstance that, in the judgment of the Principal Investigator, could jeopardize patient safety or interfere with the objectives of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Junmin Li，Ph.D
Shanghai, Shanghai Municipality, 200025
Junmin Li, Ph.D, 13817712211, Rjlijunmin@163.com
Junmin Li, Ph.D
About this study
Official title: Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Effectiveness of MRX2843 Tablets in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Patients will receive oral MRX2843 for 28 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations.
Read the detailed description
It is open-label, dose escalation study designed to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of orally administered MRX2843 as a single agent given daily for 28 days.
The study includes two parts, Phase I and Phase II, and is carried out in three phases. The Phase I clinical study is divided into two phases: the dose escalation study (Ia) and the expanded enrollment study (Ib). The third phase is the phase II research phase, which is designed based on phase I clinical results.
Phase Ia：Cohorts of 3 patients receive MRX2843 until dose limiting toxicity is noted (DLT). At that point cohorts will expand to 6 patients until MTD is determined.
Phase Ib/ II：According to the relevant data on safety and effectiveness, expand the enrollment of FLT3 mutation relapsed/refractory AML patients at the appropriate dose
- Conditions
- Acute Myeloid Leukemia Leukemia
- Being tested
- MRX2843
- Keywords
- MRX2843
- 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.
MRX2843Drug
MRX2843 is treated at 80mg/d, 120mg/d and 180mg/d respectively
| Study group | Role | What they receive |
|---|---|---|
| MRX2843 orally 80 mg/d | Experimental | Participants received 80 mg MRX2843 administered orally (PO), once daily (QD), in a fasted state on Days
1 to 21 of a 21-day cycle. Receives: Drug: MRX2843 |
| MRX2843 orally 120 mg/d | Experimental | Participants received 120 mg MRX2843 administered orally (PO), once daily (QD), in a fasted state on Days
1 to 21 of a 21-day cycle. Receives: Drug: MRX2843 |
| MRX2843 orally 180 mg/d | Experimental | Participants received 180 mg MRX2843 administered orally (PO), once daily (QD), in a fasted state on Days
1 to 21 of a 21-day cycle. Receives: Drug: MRX2843 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety: Incidence of dose limiting toxicity (DLT)and Adverse Event (AE)
Measured: 28 Days
RP2D
Explore the maximum tolerated dose (MTD) and phase II recommended dose (RP2D), and initially formulate a reasonable dosing plan;
Measured: 28 Days
Secondary outcomes (11)
Maximum serum concentration (Cmax)
Maximum serum concentration (Cmax)
Measured: 28 Days
Area under the plasma concentration-time curve (AUC) from time zero to the time point of t (AUC0-tn)
Area under the plasma concentration-time curve (AUC) from time zero to the time point of t (AUC0-tn)
Measured: 28 Days
Area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC0-inf)
Area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC0-inf)
Measured: 28 Days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 28 Days
Apparent volume of distribution at equilibrium after oral administration（Vss/F）
Apparent volume of distribution at equilibrium after oral administration（Vss/F）
Measured: 28 Days
Plasma Decay Half-Life (t1/2z)
Plasma Decay Half-Life (t1/2z)
Measured: 28 Days
Apparent Oral Clearance (CLz/F)
Apparent Oral Clearance (CLz/F)
Measured: 28 Days
Average plasma or serum concentration(Cav)
Average plasma or serum concentration(Cav)
Measured: 28 Days
changes in FLT3 mutation status in plasma
changes in FLT3 mutation status in plasma
Measured: 28 Days
Rate of Complete Remission (CR)
Rate of Complete Remission (CR)
Measured: 28 Days
Rate of partial remission (PR)
Rate of partial remission (PR)
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Jul 2021 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia LeukemiaStudies of the same condition, open and under way.
- More trials run by Betta Pharmaceuticals 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946890
- Sponsor's protocol ID
- BTP-66M12
- Status last verified
- Jun 2021
- First submitted
- 23 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Effectiveness of MRX2843 Tablets in Patients With Relapsed/Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT04946890
- Acronym / sponsor ID
- BTP-66M12
- Conditions
- Acute Myeloid Leukemia Leukemia
- Keywords
- MRX2843
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Jul 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.
Patients will receive oral MRX2843 for 28 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations.
Detailed description
It is open-label, dose escalation study designed to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of orally administered MRX2843 as a single agent given daily for 28 days.
The study includes two parts, Phase I and Phase II, and is carried out in three phases. The Phase I clinical study is divided into two phases: the dose escalation study (Ia) and the expanded enrollment study (Ib). The third phase is the phase II research phase, which is designed based on phase I clinical results.
Phase Ia：Cohorts of 3 patients receive MRX2843 until dose limiting toxicity is noted (DLT). At that point cohorts will expand to 6 patients until MTD is determined.
Phase Ib/ II：According to the relevant data on safety and effectiveness, expand the enrollment of FLT3 mutation relapsed/refractory AML patients at the appropriate dose
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MRX2843 orally 80 mg/d | Experimental | Drug: MRX2843Participants received 80 mg MRX2843 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 21 of a 21-day cycle. |
| MRX2843 orally 120 mg/d | Experimental | Drug: MRX2843Participants received 120 mg MRX2843 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 21 of a 21-day cycle. |
| MRX2843 orally 180 mg/d | Experimental | Drug: MRX2843Participants received 180 mg MRX2843 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 21 of a 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males and females age ≥ 18 years;
- Expected survival period ≥ 12 weeks;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Histopathologically documented primary or secondary AML, as defined by WHO criteria, confirmed by pathology review at treating institution, meeting at least one of the following: i. After complete remission, leukemia cells reappear in peripheral blood, or the ratio of bone marrow immature cells to bone marrow cells> 5%, or leukemia cell infiltration outside the bone marrow; ii. After standard protocol (including cytarabine and a kind of Anthracycline or anthraquinone drugs) for refractory AML patients who have not achieved complete remission after two courses of treatment;
- During the dose escalation phase, there is no need to test for FLT3 mutation status; for the expansion of the enrollment and phase II study phase, the FLT3 mutation status test results within the past 6 months will be accepted; if not, the central laboratory or research center needs to test and confirm the test Patients with FLT3 mutation status in bone marrow or whole blood. The test results show that the subject has any of the following FLT3 mutation types, and can be included in the group: FLT3 internal tandem repeat (ITD), FLT3 tyrosine kinase domain (TKD);
Key exclusion criteria (17 listed)
- Previously received medications targeting MerTK and/or FLT3
- Histologic diagnosis of acute promyelocytic leukemia;
- Have had other malignant tumors in the past 5 years ;
- Persistent clinically significant toxicity from prior chemotherapy that is Grade 2 or higher;
- The tumor involves the central nervous system and/or the testis;
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 |
|---|---|---|
| MRX2843MRX2843 is treated at 80mg/d, 120mg/d and 180mg/d respectively | Drug | MRX2843 orally 120 mg/d, MRX2843 orally 180 mg/d, MRX2843 orally 80 mg/d |
Primary outcome
Safety
Time frame: 28 Days
Safety: Incidence of dose limiting toxicity (DLT)and Adverse Event (AE)
RP2D
Time frame: 28 Days
Explore the maximum tolerated dose (MTD) and phase II recommended dose (RP2D), and initially formulate a reasonable dosing plan;
11 secondary outcomes
Maximum serum concentration (Cmax)
Time frame: 28 Days
Area under the plasma concentration-time curve (AUC) from time zero to the time point of t (AUC0-tn)
Time frame: 28 Days
Area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC0-inf)
Time frame: 28 Days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 28 Days
Apparent volume of distribution at equilibrium after oral administration（Vss/F）
Time frame: 28 Days
Plasma Decay Half-Life (t1/2z)
Time frame: 28 Days
Apparent Oral Clearance (CLz/F)
Time frame: 28 Days
Average plasma or serum concentration(Cav)
Time frame: 28 Days
changes in FLT3 mutation status in plasma
Time frame: 28 Days
Rate of Complete Remission (CR)
Time frame: 28 Days
Rate of partial remission (PR)
Time frame: 28 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MRX2843 in people with Acute Myeloid Leukemia Leukemia, run by Betta Pharmaceuticals 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 11 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 1 Jul 2021. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junmin Li, Ph.D (13817712211, Rjlijunmin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 28 Days). The study lists 2 primary outcomes in all. 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 Jul 2021.