Acute Myeloid Leukemia Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

17

Study ID:

NCT04629443

Recruitment Status:

Terminated

Sponsor:

Institut de Recherches Internationales Servier

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There are 6 Locations for this study

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University of Texas MD Anderson Cancer Center Department of Leukemia, Division of Cancer Medicine
Houston Texas, 77030, United States
Victorian Comprehensive Cancer Centre
Melbourne , 3002, Australia
The Alfred Hospital Malignant Haematology & Stem Cell Transplantation Services
Melbourne , 3004, Australia
Institut Paoli-Calmettes
Marseille , , France
Hôpital Saint Antoine
Paris , 75012, France
H. Universitario Valle de Hebrón Servicio de Hematología
Barcelona , 08035, Spain
H. Universitario La Fe Servicio de Hematologia
Valencia , 46026, Spain

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

17

Study ID:

NCT04629443

Recruitment Status:

Terminated

Sponsor:


Institut de Recherches Internationales Servier

How clear is this clinincal trial information?

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