Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia

Completed · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukaemia

In brief

The purpose of this study is to assess the safety, tolerability and clinical activity of the combination S64315 with azacitidine in patients with acute myeloid leukaemia.

Key facts

Study ID

NCT04629443

Run by

Institut de Recherches Internationales Servier

People needed

17

Starts

2021-02-17

Expected to finish

2023-08-25

Last updated by the study team

2024-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged ≥ 18 years
• Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML as defined by World Health Organization 2016 classification (Arber, 2016) excluding acute promyelocytic leukaemia (APL, French American-British M3 classification) with: relapsed or refractory disease and without established alternative therapy, or secondary to MyeloDysplastic Syndrome and without established alternative therapy or, newly diagnosed AML, not previously treated for AML and who are not candidate for intensive chemotherapy due to age or comorbidities.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Adequate haematological, renal and hepatic functions based on the last assessment performed within 7 days prior to the first Investigational Medicinal Product administration.

You may not qualify if…

• Previous myeloproliferative syndrome (MPS).
• Patients previously treated with any Mcl-1 inhibitor.
• Patients who have not recovered from toxicity of previous anticancer therapy, including Grade ≥ 2 toxicity (except alopecia of any grade) according to the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) version 5.0, prior to the first IMP administration.
• Severe or uncontrolled active acute or chronic infection.
• Uncontrolled hepatitis B or C infection.
• Known carriers of HIV antibodies, history of significant liver disease, active acute or chronic pancreatitis, active central nervous system disease.
• Troponin > ULN (Upper Limit of reference range) or Troponin T > ULN if Troponin I cannot be assessed.
• Clinically significant cardiac dysfunction (including New York Heart Association class ≥II heart failure, Left Ventricular Ejection Fraction (LVEF) < 50% as assessed by echocardiography (ECHO) or Multi-Gated Acquisition (MUGA) scan).
• QT prolongation defined as QTc (QT interval corrected for heart rate) interval (corrected with Fridericia's formula) > 450 ms for males and > 470 ms for females, obtained from triplicate 12-lead ECG.
• Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age.
• Uncontrolled arterial hypertension (systolic blood pressure (SBP) > 150 mmHg or diastolic blood pressure (DBP) > 95 mmHg).

Where it is running

• University of Texas MD Anderson Cancer Center Department of Leukemia, Division of Cancer Medicine — Houston, Texas, United States
• Victorian Comprehensive Cancer Centre — Melbourne, Australia
• The Alfred Hospital Malignant Haematology & Stem Cell Transplantation Services — Melbourne, Australia
• Institut Paoli-Calmettes — Marseille, France
• Hôpital Saint Antoine — Paris, France
• H. Universitario Valle de Hebrón Servicio de Hematología — Barcelona, Spain
• H. Universitario La Fe Servicio de Hematologia — Valencia, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.