Phase I Study of HMPL-523+Azacitidine in Elderly Patients With Acute Myeloid Leukemia

• Status: Terminated
• Trial end date: 2019-09-09
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I, open-label, non-randomized, multicenter study to evaluate the safety, pharmacokinetics and preliminary efficacy of HMPL-523 in combination with Azacitidine in previously untreated elderly patients with AML who are not eligible for standard induction therapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hutchison Medipharma Limited
• Treatments: Azacitidine

Criteria

Inclusion Criteria:

1. Subject must have confirmation of AML by WHO criteria, except for APL (M3)

2. Subject must be ≥ 65 years of old and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidity or other factors

3. Subject must have received no prior treatment for AML with the exception of hydroxyurea

4. ECOG performance status of 0-1. For dose-expansion stage, ECOG PS of 2 will also be eligible

Exclusion Criteria:

1. Subject has received treatment of hypomethylating agent and/or chemo therapeutic agent for MDS or MPN

2. Subject has known active CNS involvement or extramedullary sarcoma from AML

3. Subject has favorable risk cytogenetics as categorized by the NCCN Guidelines Version 1, 2018 for Acute Myeloid Leukemia, such as inv(16) or t(16;16) or t(8;21) or t(15;17)

4. Subject has a white blood cell count > 25 × 109/L (Hydroxyurea is permitted to meet this criterion)

5. Subject with serum amylase or lipase > the ULN

6. Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load.

7. Subject who don't have enough liver or renal function

8. Subject with New York Heart Association (NYHA) Class III or greater congestive heart failure

9. Subject received herbal therapy ≤ 1 week prior to initiation of study treatment

10. Subject received prior treatment with any SYK inhibitors (Fostamatinib) or FLT3 inhibitor (Quizartinib) or multi-target inhibitor with SYK or FLT3 inhibition activity (Midostaurin)