Phase I/II Trial of S65487 Plus Azacitidine in Acute Myeloid Leukemia

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety, tolerability and clinical activity of the combination S65487 with azacitidine in patients with acute myeloid leukaemia.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Recherches Internationales Servier
• Collaborator: ADIR, a Servier Group company
• Treatments: Azacitidine

Criteria

Inclusion Criteria:

• Male or female participant aged ≥ 18 years old

• Participants with cytologically confirmed and documented treatment naïve, de novo or secondary AML defined by WHO 2016 classification (Arber, 2016). Secondary AML includes:

• Previous myelodysplastic syndrome transformed

• AML due to exposure to potentially leukemogenic therapies or agents (e.g. radiation therapy, alkylating agents, topoisomerase II inhibitors) with the primary malignancy in remission for at least 3 years

• Participants not eligible for standard induction chemotherapy

• Aged ≥ 75 years old

• Or Age ≥18 years with at least one of the following comorbidities:

• Clinically significant heart or lung comorbidities, as reflected by at least one of:

• Lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected

• Forced expiratory volume in 1 second (FEV1) ≤65% of expected

• Other contraindication(s) to anthracycline therapy (must be documented)

• Other comorbidity that the Investigator judges as incompatible with intensive remission induction chemotherapy, which must be documented

• ECOG (Eastern Cooperative Oncology Group) performance status should be (criterion should be rechecked at inclusion visit) ECOG ≤ 2.

• Written informed consent obtained prior any study-specific procedure as described in section 13.3 of the protocol.

• Adequate renal and hepatic function

• Circulating White Blood Cell Count (WBC count) < 25*109 G/L (with or without use of hydroxycarbamide/leukapheresis)

• Serum potassium, serum calcium, serum phosphates, serum magnesium within normal limits with or without supplementation.

Exclusion Criteria:

• Major surgery within 3 weeks prior to the first IMP administration, or participants who have not recovered from side effects of the surgery

• Any radiotherapy within 3 weeks before the first IMP administration,

• Allogenic stem cell transplant within 3 months before the first IMP administration and/or participants with active Graft-versus-host disease within 3 months before the first IMP administration and/or participants who still receive immunosuppressive treatment within 3 months before the first IMP administration and/or participant who receive donor lymphocyte infusion (DLI) within 3 months before the first IMP administration

• Acute promyelocytic leukemia (APL, French-American-British M3 classification)

• Favorable risk cytogenetics such as t(8;21), inv(16) or t(16;16) or t(15;17) as per the National Comprehensive Cancer Network (NCCN) Guidelines Version 2, 2016 for Acute Myeloid Leukemia

• Treatment with hypomethylating agents (decitabine/azacitidine) or Venetoclax for AHD (antecedent hematologic disorders) in the 3 months prior to the first IMP intake