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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03412292

Registration number

NCT03412292

Ethics application status

Date submitted

8/01/2018

Date registered

26/01/2018

Date last updated

19/01/2022

Titles & IDs

Public title

MAX-40279 in Subjects With Acute Myelogenous Leukemia (AML)

Scientific title

A Phase I Trial of MAX-40279 Given Orally to Subjects With Acute Myelogenous Leukemia (AML)

Secondary ID [1]

Maxinovel

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acute Myelogenous Leukemia (AML)

Condition category

Condition code

Cancer

Leukaemia - Acute leukaemia

Cancer

Leukaemia - Chronic leukaemia

Cancer

Children's - Leukaemia & Lymphoma

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - MAX-40279

Experimental: MAX-40279 - MAX-40279 is provided as a capsule for oral use at 5mg, 25mg. In the dose-escalation phase, patients will be enrolled sequentially into the 5 dose levels of MAX-40279 designated in this study: 20, 40, 70, 100 and 120 mg/day (3-6 patients per cohort),bid.For each dose level, a single dose of MAX-40279 will be first administered orally followed by 1 day observation, then continuous treatment will start 4 weeks treatment (per cycle).

After completion of the dose escalation, additional patients will be enrolled into dose expansion at the Maximum tolerated dose(MTD), up to 12 patients will be enrolled into expansion cohorts.

Treatment: Drugs: MAX-40279
MAX-40279, is a multi-targeted kinase inhibitor inhibitor mainly target FLT3 and FGFR. It has a molecular weight of 496.56 Daltons, which has a formula of C24H25FN6O3S.

MAX-40279 is yellow powder. It is insoluble in water, methanol, ethanol, 0.1 mol/L hydrochloride solution or 0.1% saline; very slightly soluble in methylene dichloride and sparingly soluble in dimethylformamide. It is stable under strong acid, strong alkali, high temperatures and exposure to light.

MAX-40279 for clinical use is presented as a sterile yellow powder packaged in capsules at 5 mg, or 25 mg doses.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Adverse events (AEs)

Timepoint [1]

8 weeks

Primary outcome [2]

Maximum tolerated dose (MTD)

Timepoint [2]

4 weeks

Secondary outcome [1]

Tmax

Timepoint [1]

First single dose(pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8, 10, 24h post-dose), Cycle 1 Day 1 (the second dose)(pre-dose),Cycle 1 Day 15(pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8, 10, 24h post-dose), Cycle 1 Day 28(pre-dose), Cycle 2 Day 28(pre-dose).

Secondary outcome [2]

Cmax

Timepoint [2]

Secondary outcome [3]

AUC

Timepoint [3]

Secondary outcome [4]

t1/2

Timepoint [4]

Secondary outcome [5]

p-FLT3 Y591

Timepoint [5]

First single dose(pre-dose), Cycle 1 Day 15(pre-dose), Cycle 1 Day 28(pre-dose), Cycle 2 Day 28(pre-dose).

Secondary outcome [6]

FGFR aberration

Timepoint [6]

First single dose(pre-dose), Cycle 1 Day 15(pre-dose), Cycle 1 Day 28(pre-dose), Cycle 2 Day 28(pre-dose).

Eligibility

Key inclusion criteria

1. Males and/or females over age 18
2. Ability to understand the purposes and risks of the trial and signed informed consent forms approved by the investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC) of the trial site was obtained before the entering the trial
3. Subject has morphologically documented primary AML or AML secondary to myelodysplastic syndrome (MDS) as defined by the World Health Organization (WHO) criteria for which no established standard therapy is available
4. ECOG performance status of 0 to 2
5. Persistent chronic clinically significant nonhematological toxicities from prior treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, HSCT, or surgery) must be Grade = 1
6. In the absence of rapidly progressing disease clearly documented by the investigator, the interval from prior treatment to time of MAX-40279 administration will be at least 2 weeks (14 days) for prior cytotoxic agents or at least 5 half-lives for prior noncytotoxic agents, including immunosuppressive therapy post HSCT
7. Acceptable liver function defined below:

* Total bilirubin = 1.5 times upper limit of normal range (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 times ULN;
8. Acceptable renal function defined below:

• Serum creatinine = 1.5 times ULN or calculated creatinine clearance (by the Cockcroft-Gault formula) = 60 mL/min
9. Acceptable coagulation status defined below:

* Prothrombin time < 1.3 times ULN
* Partial thrombin time < 1.3 times ULN
10. No clinically significant abnormalities in urinalysis
11. Female participants of child bearing potential agree not to be pregnant or lactating during the study and for three months following the last dose of study drug. Both men and women of reproductive potential must agree to use a highly effective method of birth control during the study and for three months following the last dose of study drug. A highly effective method of contraception is defined as one that results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Disease diagnosis of acute promyelocytic leukemia
2. 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
3. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
4. Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery
5. Percutaneous coronary intervention conducted within 6 months prior to the trial entry for cardiac infarction or angina pectoris
6. Seizure disorders requiring anticonvulsant therapy
7. Taking a medication that prolongs QT interval and has a risk of Torsades de Pointes,or a history of long QT syndrome
8. Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product
9. Participation in an investigational drug or device trial within 4 weeks prior to the trial entry
10. Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
11. Recent venous thrombosis (including deep vein thrombosis or pulmonary embolism within 1 year of study)
12. History of upper gastrointestinal hemorrhage, peptic ulcer disease, or bleeding diathesis
13. Subject is pregnant (positive serum beta human chorionic gonadotropin [ß-HCG] test at screening) or is currently breast-feeding, their partner anticipates becoming pregnant/impregnating during the trial or within 6 months after receiving the last dose of trial treatment
14. 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
15. Unwillingness or inability to comply with the trial protocol for any reason
16. Legal incapacity or limited legal capacity
17. Cardiac disease with New York Heart Association (NYHA) Class III or IV, including congestive heart failure, myocardial infarction within 6 months prior to the trial entry, unstable arrhythmia, or symptomatic peripheral arterial vascular

Study design

Purpose of the study

Treatment

Allocation to intervention

Not applicable

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Phase 1

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

UNKNOWN

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/08/2018

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

1/12/2022

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,VIC

Recruitment hospital [1]

St Vincent's Hospital Sydney Limited - Darlinghurst

Recruitment hospital [2]

Western NSW Local Health District - Dubbo

Recruitment hospital [3]

Monash Health - Clayton

Recruitment hospital [4]

Austin Health - Heidelberg

Recruitment postcode(s) [1]

2010 - Darlinghurst

Recruitment postcode(s) [2]

2830 - Dubbo

Recruitment postcode(s) [3]

3168 - Clayton

Recruitment postcode(s) [4]

3084 - Heidelberg

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Maxinovel Pty., Ltd.

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

This is a dose-escalation phase I trial to evaluate the safety and tolerability of MAX-40279 in subjects with acute myelogenous leukemia(AML).

Trial website

https://clinicaltrials.gov/study/NCT03412292

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Chun Fong, MD

Address

Country

Phone

+61394965000

Fax

[email protected]

Contact person for scientific queries

Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03412292

Trial Review

Did you know?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03412292