AMLPhase 1NCT04187495
Study of MAX-40279 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)
A Phase 1 study testing MAX-40279-01 in people with AML, run by Maxinovel Pty., Ltd. at 1 site in China.
Trial summary
This is a non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-40279-01 in patients with Relapsed or Refractory AML. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML
- What is being tested?
- MAX-40279-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2019to 1 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and/or females over age 18.
- Subject has morphologically documented relapsed or refractoryprimary AML as defined by the World Health Organization (WHO) 2016 criteria for which no established standard therapy is available.
- ECOG performance status of 0 to 2.
- Persistent chronic clinically significant non-hematological toxicities from prior treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, HSCT, or surgery) must be Grade ≤ 1.
- Any anti-tumor treatment with radiation therapy, surgery, or immunotherapy wihtin 2 weeks prior to trial entry.
- Life expectancy of at least 3 months.
- Both men and women of reproductive potential must agree to use a highly effective method of birth control during the study and for six months following the last dose of study drug.
Who cannot join
- Disease diagnosis of acute promyelocytic leukemia.
- Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
- Previously treated malignancies other than the current disease, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years at the trial entry.
- Laboratory values not within the Protocol-defined range.
- Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, 310003
Zhen Cai, MD,PhD, caiz@zju.edu.cn
About this study
Official title: A Phase I Study for Tolerance and Pharmacokinetic Characteristic of MAX-40279 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia
This is a non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-40279-01 in patients with Relapsed or Refractory AML.
Read the detailed description
This is a two-part study comprised of a dose escalation part and a dose expansion part.
- Conditions
- AML
- Being tested
- MAX-40279-01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAX-40279-01Drug
Part 1: Dose escalation, MAX-40279-01 twice daily with dose modifications based on tolerability criteria.
Part 2: Dose expansion, Recommended doses from Part 1.
For each dose level, a single dose of MAX-40279-01 will be first administered orally followed by 1 day observation, then continuous treatment will start 4 weeks treatment (per cycle).
| Study group | Role | What they receive |
|---|---|---|
| MAX-40279-01 | Experimental | Not described Receives: Drug: MAX-40279-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Incidence of treatment-related AEs
Measured: 8 weeks
Maximum tolerated dose (MTD）
MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 4 weeks of multiple dosing.
Measured: 4 weeks
Phase II dose (RP2D)
The number and proportion of patients experiencing at least 1 dose-limiting toxicity (DLT) will be used as the primary measure to evaluate the RP2D of MAX-40279-01.
Measured: 4 weeks
Secondary outcomes (5)
Tmax
Time to maximum plasma concentration
Measured: Approximately 4 weeks
Cmax
Maximum plasma drug concentration
Measured: Approximately 4 weeks
AUC
Area under the time-concentration curve
Measured: Approximately 4 weeks
t1/2
Observed terminal half-life
Measured: Approximately 4 weeks
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on IRWG.
Measured: 1 months (anticipated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start16 Apr 2019
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxinovel Pty., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187495
- Sponsor's protocol ID
- MAX-40279-002
- Status last verified
- Jan 2022
- First submitted
- 3 Dec 2019
- Last updated
- 19 Jan 2022
- 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 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study for Tolerance and Pharmacokinetic Characteristic of MAX-40279 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia
- ClinicalTrials.gov ID
- NCT04187495
- Acronym / sponsor ID
- MAX-40279-002
- Conditions
- AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Maxinovel Pty., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 5 Dec 2019 (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 is a non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-40279-01 in patients with Relapsed or Refractory AML.
Detailed description
This is a two-part study comprised of a dose escalation part and a dose expansion part.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAX-40279-01 | Experimental | Drug: MAX-40279-01 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and/or females over age 18.
- Subject has morphologically documented relapsed or refractoryprimary AML as defined by the World Health Organization (WHO) 2016 criteria for which no established standard therapy is available.
- ECOG performance status of 0 to 2.
- Persistent chronic clinically significant non-hematological toxicities from prior treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, HSCT, or surgery) must be Grade ≤ 1.
- Any anti-tumor treatment with radiation therapy, surgery, or immunotherapy wihtin 2 weeks prior to trial entry.
Key exclusion criteria (5 listed)
- Disease diagnosis of acute promyelocytic leukemia.
- Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
- Previously treated malignancies other than the current disease, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years at the trial entry.
- Laboratory values not within the Protocol-defined range.
- Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial.
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 |
|---|---|---|
| MAX-40279-01Part 1: Dose escalation, MAX-40279-01 twice daily with dose modifications based on tolerability criteria. Part 2: Dose expansion, Recommended doses from Part 1. For each dose level, a single dose of MAX-40279-01 will be first administered orally followed by 1 day observation, then continuous treatment will start 4 weeks treatment (per cycle). | Drug | MAX-40279-01 |
Primary outcome
Adverse events (AEs)
Time frame: 8 weeks
Incidence of treatment-related AEs
Maximum tolerated dose (MTD）
Time frame: 4 weeks
MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 4 weeks of multiple dosing.
Phase II dose (RP2D)
Time frame: 4 weeks
The number and proportion of patients experiencing at least 1 dose-limiting toxicity (DLT) will be used as the primary measure to evaluate the RP2D of MAX-40279-01.
5 secondary outcomes
Tmax
Time frame: Approximately 4 weeks
Cmax
Time frame: Approximately 4 weeks
AUC
Time frame: Approximately 4 weeks
t1/2
Time frame: Approximately 4 weeks
Objective response rate (ORR)
Time frame: 1 months (anticipated)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 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.
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 MAX-40279-01 in people with AML, run by Maxinovel Pty., 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 7 inclusion and 5 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 19 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanying Bao, MD,Ph.D (+86-21-51370693, hybao@maxinovel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: 8 weeks). The study lists 3 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 19 Jan 2022.