CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
ASLAN003drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03451084
NCT03451084Phase 2Completed
CompareCT.gov

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

ASLAN Pharmaceuticals·interventional·Posted Mar 1, 2018·Updated Jul 6, 2021

In Brief

A Phase 2 clinical trial evaluating ASLAN003 for Acute Myeloid Leukemia. Completed, enrolled 24 participants across 8 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesAustralia, Singapore, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMar 1, 2018
Enrollment StartJan 5, 2018
Primary CompletionSep 11, 2019
Study CompletionDec 13, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.3 years ago

Interventions

ASLAN003drug

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.