Spots Global Cancer Trial Database for A Study of APG-115 Alone or Combined With Azacitidine in Patients With AML, CMML, or MDS

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Trial Identification

Brief Title: A Study of APG-115 Alone or Combined With Azacitidine in Patients With AML, CMML, or MDS

Official Title: A Phase Ib/II Study of APG-115 Alone or in Combination With Azacitidine in Patients With Relapse/Refractory AML, CMML or MDS

Study ID: NCT04358393

Conditions

AML

Acute Myeloid Leukemia

Chronic Myelomonocytic Leukemia

CMML

Myelodysplastic Syndromes

High-risk Myelodysplastic Syndrome

MDS

Interventions

APG-115

5-azacitidine

Study Description

Brief Summary: This is a two Part study in patients with relapsed/refractory acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), or high risk myelodysplastic syndrome (MDS) that will initially evaluate the safety and tolerability of APG-115 as a single agent in Part 1, followed by a combination of APG-115 + 5-azacitidine (5-AZA) in Part 2.

Detailed Description: Part 1: Dose escalation of APG-115 will use standard 3+3 design. APG-115 is administered orally once daily (QD) on Day 1-5 every 28-day cycle. The starting target dose is 100 mg (dose level; DL1) and will be increased in subsequent cohorts to 150 mg (DL2), 200 mg (DL3), and 250 mg (DL4), accordingly. Part 2: Dose escalation of APG-115 in combination with 5-AZA will use standard 3+3 design. 5-AZA is administered at 75 mg/m˄2/d subcutaneously daily on Day 1-7 every 28 days.