Phase I Dose Escalation Study of Intravenously Administered S64315 in Combination With Orally Administered Venetoclax in Patients With Acute Myeloid Leukaemia.

  • STATUS
    Recruiting
  • End date
    Jan 31, 2024
  • participants needed
    40
  • sponsor
    Institut de Recherches Internationales Servier
Updated on 1 May 2022
direct bilirubin
gilbert's syndrome
serum bilirubin level
acute promyelocytic leukemia
venetoclax

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.

Details
Condition Acute Myeloid Leukaemia
Treatment S 64315 (also referred as MIK665) and venetoclax
Clinical Study IdentifierNCT03672695
SponsorInstitut de Recherches Internationales Servier
Last Modified on1 May 2022

Eligibility

Yes No Not Sure

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
AST and ALT ≤ 1.5 x ULN
Total serum bilirubin level ≤ 1.5 x ULN, except for patients with known Gilbert's syndrome, who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN

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
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