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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03451084




Registration number
NCT03451084
Ethics application status
Date submitted
23/01/2018
Date registered
1/03/2018
Date last updated
6/07/2021

Titles & IDs
Public title
A Dose Optimisation Study of ASLAN003 in Acute Myeloid Leukemia
Scientific title
A Phase IIA Dose Optimisation Study of ASLAN003 in Acute Myeloid Leukemia
Secondary ID [1] 0 0
ASLAN003-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ASLAN003

Experimental: Part 1: Dose Level 1 -

Experimental: Part 1: Dose Level 2 -

Experimental: Part 1: Dose Level 3 -

Experimental: Part 1: Dose Level 4 -

Experimental: Part 2:ASLAN003 at Optinum Dose Level -1 & Azacitidine -

Experimental: Part 2:ASLAN003 at Optinum Dose Level & Azacitidine -


Treatment: Drugs: ASLAN003
Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, QD or BID. It is recommended to administer the study drug with food or within 30 minutes after food intake.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Complete Remission Rate
Timepoint [1] 0 0
4 months after study treatment
Primary outcome [2] 0 0
Number of Participants With Adverse Events
Timepoint [2] 0 0
Through 28 days post last study medication administration
Primary outcome [3] 0 0
Safety Assessments
Timepoint [3] 0 0
Through 28 days post last study medication administration
Secondary outcome [1] 0 0
Relapse Free Survival
Timepoint [1] 0 0
From 12 weeks post end of treatment (EOT) until the date of first documented relapse or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcome [2] 0 0
Clinical Benefit Rate
Timepoint [2] 0 0
4 months after study treatment
Secondary outcome [3] 0 0
% Change From Baseline in BM Blasts at Day 29
Timepoint [3] 0 0
Baseline and day 29

Eligibility
Key inclusion criteria
1. Patients who are of or older than 18 years old in the United States or are of or older than the legal age in the respective countries at the time when written informed consent is obtained
2. Patients who are able to understand and willing to sign the informed consent form (ICF)
3. Patients who are diagnosed with AML according to the 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia (refer to Appendix 1: WHO Classification of Acute Myeloid Leukemia)
4. Patients who have a sufficient archival or fresh BM aspiration sample for the evaluation of relevant exploratory endpoint.

Note: Patients who do not have sufficient archival BM aspiration sample and refuse to repeat the procedure may be enrolled in the trial only after written confirmation by ASLAN 5. Part 1: Patients who are ineligible for standard treatment of AML including to the following conditions:

* Patients who are ineligible for chemotherapy, and have exhausted any approved and available treatment options. More details on patients who are considered as ineligible or unfit for chemotherapy as per Ferrara et al, Leukemia, 2013 can be found in Appendix 4.
* Patients who have relapsed from prior remission;
* Patients who have failed to respond to prior therapy including chemotherapy, hypomethylating agents, and bone marrow transplantation.

5. Part 2A: Patients who have relapsed or refractory AML to treatments including chemotherapy, hypomethylating agents, bone marrow transplantation, and other anti-leukemic agents
* Relapsed patients who have bone marrow blasts =5%; or reappearance of blasts in the blood; or development of extramedullary disease after prior CR or CRi
* Refractory patients who have no CR or CRi after 2 courses of intensive induction treatment 5. Part 2B: Older patients (more than or equal to 60 years) AML patients who have exhausted any approved and available treatment options.

6. Patients who have an ECOG performance status of = 2 7. Patients with adequate renal and hepatic function, as defined below:
* Estimated Glomerular Filtration Rate (eGFR) or creatinine clearance (CrCl) (CrCl calculated by the Cockroft and Gault method) = 40 ml/min/1.73 m2
* Total bilirubin, AST, and ALT = 1.5 × ULN
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who are diagnosed with de novo myeloid sarcoma without BM involvement
2. Patients who are diagnosed with acute promyelocytic leukemia/retinoic acid receptor alpha (PML-RARA)
3. Patients who received any other standard or investigational treatment for their leukemia within the last 7 days before starting the first dose of study drug, with the exception of leukapheresis and hydroxyurea
4. Patients with unresolved serious toxicity (= CTCAE 4.03 Grade 2) from prior administration of standard or investigational treatment for their leukemia
5. Patients who have a positive test for human immunodeficiency virus (HIV), viral hepatitis C infection (patients with sustained viral response are not excluded), active viral hepatitis B infection (positive hepatitis B surface antigen [HBsAg]) with hepatitis B virus deoxyribonucleic acid (DNA) exceeding 2000 IU/ml
6. Patients who have a known history of liver cirrhosis Child-Pugh score B or C
7. Patients who have any history of other malignancy unless in remission for more than 1 year (skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent is not exclusionary)
8. Female patients who are pregnant or breast-feeding
9. Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment
10. Patients with a history or presence of a clinically significant condition which in the opinion of the Investigator could jeopardize the safety of the patient or the validity of the study results
11. Patients who have been previously treated with ASLAN003

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/12/2019
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
1 Site - Albury
Recruitment hospital [2] 0 0
3 Sites - Darlinghurst
Recruitment hospital [3] 0 0
1 Site - Waratah
Recruitment hospital [4] 0 0
1 Site - Douglas
Recruitment hospital [5] 0 0
1 Site - Adelaide
Recruitment hospital [6] 0 0
3 Sites - Melbourne
Recruitment postcode(s) [1] 0 0
- Albury
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Waratah
Recruitment postcode(s) [4] 0 0
- Douglas
Recruitment postcode(s) [5] 0 0
- Adelaide
Recruitment postcode(s) [6] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Kentucky
Country [2] 0 0
Singapore
State/province [2] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
ASLAN Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
ASLAN003-003 is a multi-center, Phase IIA study to evalute the efficacy of ASLAN003 in AML patients who are ineligible for standard treatment with an expansion cohort in relapsed/refractory patients, and to determine the appropriate dose of ASLAN003 in combination with azacitidine in older (more than or equal to 60 years) AML patients who have exhausted any approved and available treatment options.
Trial website
https://clinicaltrials.gov/study/NCT03451084
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03451084