Status:
ACTIVE_NOT_RECRUITING
Phase I/II Trial of S65487 Plus Azacitidine in Acute Myeloid Leukemia
Lead Sponsor:
Institut de Recherches Internationales Servier
Collaborating Sponsors:
ADIR, a Servier Group company
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
The study is designed in two parts: A dose escalation phase I part, and a dose expansion phase II part with an additional potential expansion cohort. During dose escalation of S65487 in combination w...
Eligibility Criteria
Inclusion
- 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
- 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 3, 2019 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
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04742101
Start Date
March 10 2021
End Date
December 30 2025
Last Update
April 11 2025
Active Locations (11)
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1
Institut Gustave Roussy
Villejuif, France, 94805
2
Semmelweis Egyetem Belgyógyászati és Onkológiai Klinika Klinikai Farmakológiai Részleg
Budapest, Hungary, H-1083
3
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie Klinika Transplantacji Szpiku i Onkohematologii pokoj 4.041 ul. Wybrzeze Armii Krajowej 15
Gliwice, Poland, 44-102
4
Seoul National University Hospital - Department of Hematology-Oncology
Seoul, South Korea, 03080