An International Phase Ib Multicentre Study to Characterize the Safety and Tolerability of Intravenously Administered S64315, a Selective Mcl-1 Inhibitor, in Combination With Orally Administered Venetoclax, a Selective Bcl-2 Inhibitor in Patients With Acute Myeloid Leukaemia (AML).

Institut de Recherches Internationales Servier7 sites in 3 countries37 target enrollmentNovember 28, 2018

ConditionsAcute Myeloid Leukaemia

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Acute Myeloid Leukaemia
Sponsor: Institut de Recherches Internationales Servier
Enrollment: 37
Locations: 7
Primary Endpoint: Incidence and severity of AEs
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the safety profile, tolerability and the Recommended Phase 2 Dose of the combination S64315 with venetoclax in patients with Acute Myeloid Leukaemia.

Registry

clinicaltrials.gov

Start Date

November 28, 2018

End Date

May 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Institut de Recherches Internationales Servier

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female aged ≥ 18 years;
•Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML as defined by World Health Organization (WHO) 2016 classification (Arber, 2016), excluding acute promyelocytic leukaemia (APL, French-American British M3 classification):
•With relapsed or refractory disease without established alternative therapy or
•Secondary to MDS treated at least by hypomethylating agent and without established alternative therapy or
•≥ 65 years not previously treated for AML and who are not candidates for intensive chemotherapy nor candidates for established alternative therapy
•Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
•Able to comply with study procedures
•Adequate renal function within 7 days before the inclusion of the patient defined as:
•Serum creatinine ≤ 1.5 x ULN (upper normal limit) or calculated creatinine clearance (determined by MDRD) \> 50 mL/min/1.73m2
•Adequate hepatic function within 7 days before the inclusion of the patient defined as:

Exclusion Criteria

•Participant already enrolled and treated in the study
•Pregnancy, breastfeeding or possibility of becoming pregnant during the study
•Participation in another interventional study requiring investigational treatment intake at the same time or within 2 weeks or at least 5 halflives (whichever is longer) prior to first dose of IMP (participation in non-interventional registries or epidemiological studies is allowed). In case of biologic agents with a long half life such as CART cells, immune checkpoint antibodies, bispecific antibodies a flat wash-out of 28 days will be acceptable
•Presence of ≥ CTCAE Grade 2 toxicity (except alopecia of any grade) due to prior cancer therapy, according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE, version 4.03).
•Known carriers of HIV antibodies
•Known history of significant liver disease
•Uncontrolled hepatitis B or C infection
•Known active acute or chronic pancreatitis
•History of myocardial infarction (MI), unstable angina pectoris, coronary artery bypass graft (CABG) within 6 months prior to starting study treatment
•Any factors that could increase the risk of QTc prolongation or risk of arrhythmic events.