NCT03451084 : A Phase IIA Dose Optimisation Study of ASLAN003 in Acute Myeloid Leukemia

Male or<br/>FemaleGender Male or

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

21+Age Over 21

Blood<br/>CancersCancer LocationBlood

Systemic therapy | Blood / Myeloma / LymphomaAcute Myeloid Leukaemia,

Trial Overview Read MoreRead more

This Phase II trial is evaluating a new oral drug (ASLAN003) as a single treatment for Acute Myeloid Leukaemia (AML).

This trial is treating patients with Acute Myeloid Leukaemia (AML).

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase IIA Dose Optimisation Study of ASLAN003 in Acute Myeloid Leukemia

Commercial Sponsor

Aslan Pharmaceuticals


This is a multicenter, single arm, non-randomised Phase IIA Study to evaluate ASLAN003 as a monotherapy in patients with AML. AML patients who are ineligible for standard treatment including, but not limited to the following conditions, will be enrolled in the study: •Newly diagnosed patients who are ineligible for standard therapy i.e., standard dose induction chemotherapy and reduced dose chemotherapy •Patients with relapse from prior remission •Patients with failed response to prior therapy including chemotherapy, hypomethylating agents, and bone marrow (BM) transplantation. Up to a total of 18 patients will be enrolled into this study - 6 patients in each dose cohort (ASLAN003 100 mg once daily (QD), 200 mg QD, and 300 mg QD, respectively). Once 6 patients have been enrolled into the cohort of 100 mg QD, recruitment will be started in the cohort of 200 mg QD. The same rule applies on the cohort of 300 mg QD. A steering committee (SC) meeting will be set up and meet to review all safety data. Clinical information, including safety and PK data obtained from this Study, will be reviewed by a SC. All patients will continue to receive ASLAN003 until disease relapse, treatment failure, unacceptable toxicity, withdrawal of consent or death.

Recruiting Hospitals Read MoreRead more

Border Medical Oncology
Ms Nyree Sarakis
02 6064 1493

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.