A Study of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With Relapsed/Re… (NCT04155580) | Clinical Trial Compass
TerminatedPhase 1
A Study of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML)
Stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
United States68 participantsStarted 2020-06-12
Plain-language summary
To evaluate the safety, pharmacokinetics (PK), and efficacy of ASTX660 when given alone and in combination with ASTX727 in participants with relapsed/refractory (R/R) acute myeloid leukemia (AML). The duration of the study is expected to be approximately 30 months.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Have a projected life expectancy of at least 12 weeks, as assessed by the Investigator.
✓. Have histological confirmation of AML by World Health Organization (WHO) 2016 criteria and are either:
✓. refractory to intensive induction chemotherapy OR
✓. relapsed after intensive induction chemotherapy or stem cell transplant OR
✓. relapsed after or refractory to treatment with molecularly targeted and/or low-intensity chemotherapeutic regimens.
✓. Have an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2.
✓. Have adequate renal function as demonstrated by measured or calculated creatinine clearance ≥60 mL/min.
✓. Have adequate liver function as demonstrated by:
Exclusion criteria
✕. Poor medical risk in the investigator's opinion because of systemic diseases in addition to the cancer under study, for example, uncontrolled infections.
✕. Known clinically active central nervous system (CNS) leukemia.
✕. BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
✕. Diagnosis of acute promyelocytic leukemia (M3 AML or APML).
What they're measuring
1
Safety Assessment: Number of participants with treatment-emergent adverse events (TEAEs)
. Second malignancy currently requiring active therapy, except breast or prostate cancer stable on or responding to endocrine therapy.
✕. Graft Versus Host Disease (GVHD), or any GVHD requiring treatment with immunosuppression. Any GVHD treatment (including calcineurin inhibitors) must be discontinued at least 28 days prior to Day 1 of study treatment.
✕. Presence of persistent toxicities of Grade \>1 from prior treatment including chemotherapy, targeted therapy, immunotherapy, experimental agents, radiation, and surgery (except for alopecia).
✕. Hypersensitivity to decitabine, ASTX727, ASTX660, or any of their excipients.