Trial Outcomes & Findings for A Dose Optimisation Study of ASLAN003 in Acute Myeloid Leukemia (NCT NCT03451084)

Last Updated: 2021-07-06

Results Overview

Defined as the proportion of patients with a best response of complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), defined in accordance with the IWG Response Criteria in AML from day 29. Treatment failure is defined as not achieving any response 4 months after study treatment. IWG Response Criteria in AML defines CR or CRi as: 1. Complete remission (CR): Bone marrow blasts \<5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 x 109/L (1000/µL); platelet count \>100 x 109/L (100,000/µL); independence of red cell transfusions 2. CR with incomplete recovery (CRi): All CR criteria except for residual neutropenia (\<1.0 x 109/L (1000/µL)) or thrombocytopenia (\<100 x 109/L (100,000/µL))

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

4 months after study treatment

Results posted on

2021-07-06

Participant Flow

An expansion cohort of 20 subjects in Part 2 was originally planned to be recruited to study the optimum dose selected by the Steering Committee. However, the study was terminated at the end of Cohort 4 due to Sponsor decision in July 2019 and did not proceed to Part 2 of the protocol. The primary and secondary endpoints were analyzed based on data from the 24 subjects in Part 1.

Participant milestones

Participant milestones
Measure	Part 1: ASLAN003 100mg QD ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 200mg QD ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 100mg BID ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 200mg BID ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
Overall Study STARTED	6	6	6	6
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	6	6	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: ASLAN003 100mg QD ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 200mg QD ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 100mg BID ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 200mg BID ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
Overall Study Withdrawal by Subject	2	1	2	1
Overall Study Disease recurrence	0	2	0	0
Overall Study Lack of Efficacy	0	3	0	1
Overall Study Death	1	0	2	0
Overall Study Physician Decision	0	0	2	2
Overall Study Disease progression (n=4), study closed by sponsor (n=1)	3	0	0	2

Baseline Characteristics

A Dose Optimisation Study of ASLAN003 in Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: ASLAN003 100mg QD n=6 Participants ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 200mg QD n=6 Participants ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 100mg BID n=6 Participants ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 200mg BID n=6 Participants ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants	8 Participants n=36 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants	4 Participants n=483 Participants	16 Participants n=36 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants	2 Participants n=483 Participants	10 Participants n=36 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	6 Participants n=4 Participants	2 Participants n=27 Participants	4 Participants n=483 Participants	14 Participants n=36 Participants
Race/Ethnicity, Customized Caucasian	1 Participants n=93 Participants	5 Participants n=4 Participants	5 Participants n=27 Participants	4 Participants n=483 Participants	15 Participants n=36 Participants
Race/Ethnicity, Customized Asian	5 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	8 Participants n=36 Participants
Race/Ethnicity, Customized Other	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	6 Participants n=93 Participants	6 Participants n=4 Participants	6 Participants n=27 Participants	6 Participants n=483 Participants	24 Participants n=36 Participants
Region of Enrollment Singapore	4 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants	1 participants n=483 Participants	7 participants n=36 Participants
Region of Enrollment Australia	2 participants n=93 Participants	5 participants n=4 Participants	5 participants n=27 Participants	5 participants n=483 Participants	17 participants n=36 Participants
Height	162.67 CM STANDARD_DEVIATION 8.189 • n=93 Participants	173.25 CM STANDARD_DEVIATION 7.640 • n=4 Participants	158.17 CM STANDARD_DEVIATION 9.827 • n=27 Participants	164.17 CM STANDARD_DEVIATION 7.627 • n=483 Participants	164.56 CM STANDARD_DEVIATION 9.604 • n=36 Participants
Weight	53.00 KG STANDARD_DEVIATION 13.549 • n=93 Participants	82.32 KG STANDARD_DEVIATION 11.216 • n=4 Participants	63.82 KG STANDARD_DEVIATION 16.551 • n=27 Participants	81.72 KG STANDARD_DEVIATION 21.244 • n=483 Participants	70.21 KG STANDARD_DEVIATION 9.637 • n=36 Participants
BMI	19.855 kg/m^2 STANDARD_DEVIATION 3.9883 • n=93 Participants	27.368 kg/m^2 STANDARD_DEVIATION 2.6446 • n=4 Participants	25.065 kg/m^2 STANDARD_DEVIATION 3.9042 • n=27 Participants	30.553 kg/m^2 STANDARD_DEVIATION 8.8254 • n=483 Participants	25.710 kg/m^2 STANDARD_DEVIATION 6.4119 • n=36 Participants

PRIMARY outcome

Timeframe: 4 months after study treatment

Population: The primary efficacy endpoint was OCRR, defined as the proportion of subjects with a best response of CR or CRi. The "Measure Type" and data in the "Outcome Measure Data Table" is reported as "Count of Participants" and corresponding proportion is provided next to the count. Two subjects who had major protocol deviations were excluded from the Evaluable for Response (EFR) analysis set. Primary and secondary efficacy analyses were performed on the EFR set.

Outcome measures

Outcome measures
Measure	Part 1: ASLAN003 100mg QD n=6 Participants ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 200mg QD n=4 Participants ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 100mg BID n=6 Participants ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 200mg BID n=6 Participants ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
Overall Complete Remission Rate Responders	0 Participants	0 Participants	0 Participants	0 Participants
Overall Complete Remission Rate Treatment Failure	2 Participants	4 Participants	2 Participants	6 Participants
Overall Complete Remission Rate Non-evaluable	4 Participants	0 Participants	4 Participants	0 Participants

PRIMARY outcome

Timeframe: Through 28 days post last study medication administration

Population: Overview of Treatment Emergent Adverse Events (TEAEs) - Safety Population

Number of Participants with Adverse Events reported through 28 days post last study medication administration

Outcome measures

Outcome measures
Measure	Part 1: ASLAN003 100mg QD n=6 Participants ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 200mg QD n=6 Participants ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 100mg BID n=6 Participants ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 200mg BID n=6 Participants ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
Number of Participants With Adverse Events Number of Patients with Any TEAE	5 participants	6 participants	6 participants	6 participants
Number of Participants With Adverse Events Number of Patients with Any TEAE related to study treatment	3 participants	4 participants	1 participants	4 participants
Number of Participants With Adverse Events Number of Patients with Any TEAE CTCAE grade 3 or higher	5 participants	5 participants	6 participants	6 participants
Number of Participants With Adverse Events Number of Patients with Any TEAE CTCAE grade 3 or higher related to study treatment	2 participants	2 participants	1 participants	2 participants
Number of Participants With Adverse Events Number of Patients with Any TEAE with outcome of death	0 participants	1 participants	0 participants	0 participants
Number of Participants With Adverse Events Number of Patients with Any TEAE with outcome of death related to study treatment	0 participants	0 participants	0 participants	0 participants
Number of Participants With Adverse Events Number of Patients with Any serious TEAE	3 participants	5 participants	4 participants	6 participants
Number of Participants With Adverse Events Number of Patients with Any serious TEAE related to study treatment	0 participants	0 participants	0 participants	1 participants
Number of Participants With Adverse Events Number of Patients with Any TEAE leading to discontinuation of study therapy	0 participants	0 participants	1 participants	0 participants
Number of Participants With Adverse Events Number of Patients with Any TEAE leading to discontinuation of study therapy related to treatment	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Through 28 days post last study medication administration

Population: The Outcome Measure Data includes number of analyzed subjects who had abnormal values for hematology and chemistry parameters and reported as AEs by the Investigators. All 24 (100%) subjects enrolled in the study were included in the safety population.

Safety Assessments - Clinical laboratory test: Hematology and Chemistry

Outcome measures

Outcome measures
Measure	Part 1: ASLAN003 100mg QD n=6 Participants ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 200mg QD n=6 Participants ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 100mg BID n=6 Participants ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 200mg BID n=6 Participants ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
Safety Assessments Hematology - Abnormal white blood cell counts reported by Investigator as AEs of leukocytosis	2 participants	3 participants	3 participants	0 participants
Safety Assessments Hematology - Abnormal/decreased hemoglobin values reported by Investigator as AEs of anaemia	3 participants	1 participants	2 participants	2 participants
Safety Assessments Hematology - Abnormal neutrophil count reported by Investigator as AE of neutropenia	0 participants	0 participants	0 participants	1 participants
Safety Assessments Hematology - Abnormal neutrophil counts reported by Investigator as AEs febrile neutropenia	0 participants	1 participants	0 participants	2 participants
Safety Assessments Hematology - Abnormal/decreased platelet count reported by Investigator as AEs of thrombocytopenia	2 participants	0 participants	2 participants	1 participants
Safety Assessments Chemistry - Abnormal serum potassium values reported by Investigator as AEs of hypokalaemia	2 participants	3 participants	2 participants	1 participants
Safety Assessments Chemistry - Elevated levels of serum glucose reported by Investigator as AEs of hyperglycaemia	1 participants	1 participants	0 participants	0 participants
Safety Assessments Chemistry - Abnormal blood creatinine reported by Investigator as AE of blood creatinine increased	0 participants	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: 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

Population: All the subjects were non-responders in this study, relapse free survival was not evaluated.

Defined as the time the criteria for remission (CR or CRi) are first met until there is evidence of patient relapse, regardless of whether the patient is still taking study drug. Relapse is defined as: * The reappearance of leukemic blasts in the peripheral blood or \> 5% blasts in the bone marrow not attributable to any other cause; * The appearance of new dysplastic changes; * The reappearance of or development of cytologically proven extrameduallary disease; * The reappearance of a cytogenetic or molecular abnormality.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 months after study treatment

Population: In addition to achieving no responses (CR or CRi) for the primary endpoint, no PRs were achieved either, thus CBR was not evaluated.

Defined as the proportion of subjects with an AML IWG best response of CR, CRi or PR. IWG Response Criteria in AML defines CR, CRi or PR as: 1. Complete remission (CR): Bone marrow blasts \<5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 x 109/L (1000/µL); platelet count \>100 x 109/L (100,000/µL); independence of red cell transfusions 2. CR with incomplete recovery (CRi): All CR criteria except for residual neutropenia (\<1.0 x 109/L (1000/µL)) or thrombocytopenia (\<100 x 109/L (100,000/µL)) 3. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5 to 25 percent; and decrease of pre-treatment bone marrow blast percentage by at least 50 percent

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and day 29

Population: Only subjects with reduction of BM blasts evaluated on Day 29 are reported as % change from baseline in the Outcome Measure data.

Percent Change from Baseline in BM Blasts at Day 29

Outcome measures

Outcome measures
Measure	Part 1: ASLAN003 100mg QD n=1 Participants ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 200mg QD n=1 Participants ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 100mg BID ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 200mg BID ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
% Change From Baseline in BM Blasts at Day 29	-34.43 Percentage change	-8.33 Percentage change	—	—

Adverse Events

Part 1: ASLAN003 100mg QD

Serious events: 3 serious events

Other events: 3 other events

Deaths: 6 deaths

Part 1: ASLAN003 200mg QD

Serious events: 5 serious events

Other events: 4 other events

Deaths: 6 deaths

Part 1: ASLAN003 100mg BID

Serious events: 4 serious events

Other events: 1 other events

Deaths: 6 deaths

Part 1: ASLAN003 200mg BID

Serious events: 6 serious events

Other events: 4 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Part 1: ASLAN003 100mg QD n=6 participants at risk ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 200mg QD n=6 participants at risk ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg QD. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 100mg BID n=6 participants at risk ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 100mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.	Part 1: ASLAN003 200mg BID n=6 participants at risk ASLAN003: Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, 200mg BID. Patients will receive a continuous 28-day treatment cycle of ASLAN003 at this dose until disease relapse, treatment failure (defined as failure to achieve a PR or higher within 4 cycles), development of unacceptable toxicity, withdrawal of consent or death. It is recommended to administer the study drug with food or within 30 minutes after food intake.
Blood and lymphatic system disorders Leukocytosis	33.3% 2/6 • Number of events 2 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	16.7% 1/6 • Number of events 1 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	16.7% 1/6 • Number of events 3 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	0.00% 0/6 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	0.00% 0/6 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	16.7% 1/6 • Number of events 1 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	16.7% 1/6 • Number of events 26 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.
Blood and lymphatic system disorders Thrombocytopenia	16.7% 1/6 • Number of events 1 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	0.00% 0/6 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	0.00% 0/6 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	16.7% 1/6 • Number of events 1 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Number of events 1 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	16.7% 1/6 • Number of events 1 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	0.00% 0/6 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	0.00% 0/6 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 1 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	0.00% 0/6 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	0.00% 0/6 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	16.7% 1/6 • Number of events 1 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.
Metabolism and nutrition disorders Decreased appetite	16.7% 1/6 • Number of events 1 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	0.00% 0/6 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	0.00% 0/6 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	16.7% 1/6 • Number of events 1 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.
Skin and subcutaneous tissue disorders Rash maculo-papular	16.7% 1/6 • Number of events 1 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	16.7% 1/6 • Number of events 1 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	0.00% 0/6 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	0.00% 0/6 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	16.7% 1/6 • Number of events 1 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	0.00% 0/6 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.	0.00% 0/6 • From the time of informed consent and until 28 days after the last administration of study drug, up to 24 months. Definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same with clinicaltrials.gov definition.

Additional Information

Study Director

ASLAN Pharmaceuticals

Phone: +65 6222 4235

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place