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AzTrials

LeukemiaPhase 1/2NCT05061147

A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Max-40279-01 in Combination With Azacitidine (AZA) in Patients With Myelodysplastic Syndrome (MDS) or Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

A Phase 1/2 study testing MAX-40279-01 in people with Leukemia and Acute Myeloid Leukemia, run by Maxinovel Pty., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a phase Ib/II study of Max-40279-01 in combination with Azacitidine (AZA) in patients with Myelodysplastic Syndrome (MDS) or Relapsed/Refractory Acute Myeloid Leukemia (R/R AML). This study include Phase Ib and Phase II study. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MAX-40279-01
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
16 Sep 2021to 31 Oct 2022
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/or females over age 18
  • A diagnosis of AML according to the World Health Organization (WHO) 2016 criteria with relapsed or refractory disease and have exhausted, or are ineligible for therapeutic options, or int-risk or high-risk or very high-risk MDS according to revised International Prognostic Scoring System (IPSS-R);
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Expected survival >3 months.
  • No radiotherapy, surgery or hormonal therapy for any kind of within 2 weeks prior to participating in this study. Patients must have fully recovered from the acute toxicities of any prior treatment with any anti-cancer drugs (including hypomethylating agents in MDS patients), radiotherapy or other anti-cancer modalities (i.e., returned to baseline status as noted before most recent treatment) for any tumors. Patients with persisting, stable chronic toxicities from such prior treatment ≤Grade 1 are eligible, but must be documented as such.
  • Signed informed consent form.

Who cannot join

  • Acute promyelocytic leukemia according to World Health Organization 2016 criteria
  • Known central nervous system involvement
  • Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product
  • Known allergies, hypersensitivity, or intolerance to Max-40279-01 or AZA or the excipients of these treatments
  • 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

Trial locations and contacts

1 site in 1 country.

Hanying Bao, MD,Ph.D contact

+86-021-51370693

hybao@maxinovel.com

China1 site, 1 recruiting

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin

    jianxiang Wang, 86-22-23909278, wangjx@ihcams.ac.cn

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Multi-Center, Phase Ib/Ⅱ Clinical Trial of Max-40279-01 in Combination With Azacitidine (AZA) in Adult Patients With Myelodysplastic Syndrome (MDS) or Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

This study is a phase Ib/II study of Max-40279-01 in combination with Azacitidine (AZA) in patients with Myelodysplastic Syndrome (MDS) or Relapsed/Refractory Acute Myeloid Leukemia (R/R AML). This study include Phase Ib and Phase II study. The phase Ib study is designed to evaluate the safety and tolerability of MAX-40279-01 in combination with Azacitidine (AZA) in patients with Relapsed or Refractory AML. The phase II study is designed to preliminarily assess the efficacy and safety of Max-40279-01 in combination with Azacitidine (AZA) in patients with Myelodysplastic Syndrome (MDS) or Relapsed/Refractory Acute Myeloid Leukemia (R/R AML).

Read the detailed description

This is a two-part study comprised of a dose escalation part and a dose expansion part.

Being tested
MAX-40279-01
Keywords
Relapsed/Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome
Medical subject headings
Leukemia, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MAX-40279-01Drug

    Also called Azacitidine (AZA)

    Drug: AZA AZA will be administered at 75 mg/m^2 by subcutaneous injection for 7 consecutive days from D1 to D7 in 28-day treatment cycles.

    Other Name: Azacitidine

    Drug: Max-40279-01 Max-40279-01 will be administered as a combination of multiple oral capsules containing 5 and 25 mg. An alternate combination of 35 mg, 50 mg and 60 mg Max-40279-01 twice a day may be utilized.

    Other Name: NA

Study groups in NCT05061147
Study groupRoleWhat they receive
Max-40279-01 in combination with Azacitidine (AZA)ExperimentalThis is an open-label Phase Ib/II clinical study. The study will be conducted in two parts: Part I: Phase Ib dose escalation. Participants receive Max-40279-01 in combination with azacytidine (AZA), with different dose schedules. Part II: Phase II dose expansion. Participants divide into positive group and negative group according to whether FLT3 gene mutation occurs, approximately 40 people per group. All participants receive the recommended dose for Part 2 of Max-40279-01 with azacytidine (AZA).
Receives: Drug: MAX-40279-01

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD)

    To explore the maximum tolerable dose (MTD) of Max-40279-01 in combination with Azacitidine (AZA) for patients with r/r AML or MDS, the recommended phase II dose (RP2D).

    Measured: Through study Part 1 completion, an average of 6 months

  2. Phase II dose (RP2D)

    Recommended phase II dose (RP2D)

    Measured: Through study Part 1 completion, an average of 6 months

  3. Overall survival(OS)

    Measured: Up to 24 months

  4. Rate of complete remission (CRc)

    including Complete Remission with incomplete Platelet recovery (CRp) and Complete Remission with incomplete hematologic recovery (CRi)

    Measured: Up to 24 months

Secondary outcomes (6)

  1. Tmax

    Time to maximum plasma concentration

    Measured: Approximately 4 weeks

  2. Cmax

    Maximum plasma drug concentration

    Measured: Approximately 4 weeks

  3. AUC

    Area under the time-concentration curve

    Measured: Approximately 4 weeks

  4. t1/2

    Observed terminal half-life

    Measured: Approximately 4 weeks

  5. 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)

  6. Safety and tolerability assessed by incidence and severity of adverse events

    All grade ≥ 3 toxicities according to CTCAE (Common Terminology Criteria for Adverse Events) version 5 will be tabulated

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2021
  2. Study start16 Sep 2021
  3. Primary completion30 Apr 2022 (estimated)
  4. Study completion31 Oct 2022 (estimated)

Resources

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05061147
Sponsor's protocol ID
MAX-40279-004
Status last verified
Sep 2021
First submitted
18 Sep 2021
Last updated
1 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MAX-40279-01 in people with Leukemia and Acute Myeloid Leukemia, 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 6 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 1 Oct 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 Hanying Bao, MD,Ph.D (+86-021-51370693, hybao@maxinovel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: Through study Part 1 completion, an average of 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05061147.

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 Oct 2021.

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