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

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Servier Protocol Code: CL1-65487-003 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT04742101 EudraCT Number: 2020-003061-19 EU Trial (CTIS) Number: 2023-510051-27-00

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How to participate in this study
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 11 locations

Study description

The study is needed to test a drug called S65487 in combination with an approved treatment called azacitidine in patients with a type of blood cancer called acute myeloid leukemia (AML).

AML is a cancer of the blood and bone marrow (the spongy tissue inside bones where blood cells are made). In AML, cancer cells have higher amounts of certain proteins. One of these proteins is BCL-2 (B-cell lymphoma-2). This protein protects cancer cells from death, allowing them to survive and multiply.

The main goals of this study are:

  • To test how safe S65487 is when combined with azacitidine.
  • To find the dose of S65487 with azacitidine that is both safe and effective (the recommended dose) for patients with AML.
  • To see how well S65487 works when combined with azacitidine in patients with AML.
Official title: Phase I / II, Open Label, Dose Escalation Part (Phase I) Followed by Non-comparative Expansion Part (Phase II), Multi-centre Study, Evaluating Safety, Pharmacokinetics and Efficacy of S65487, a Bcl2 Inhibitor Combined With Azacitidine in Adult Patients With Previously Untreated Acute Myeloid Leukemia Not Eligible for Intensive Treatment
Conditions
Acute Myeloid Leukemia
Interventions / Treatments
  • S65487 and azacitidine
Other study id numbers
  • CL1-65487-003

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sex

Male/Female

Accepts Healthy Volunteers

No

To take part in the study, participants have to:

  • Be at least 18 years old.
  • Have confirmed AML that has not been treated before.
  • Have adequate kidney, liver, and heart function.

Participants cannot take part in the study if they:

  • Had radiation therapy or major surgery within 3 weeks before starting the study.
  • Have previously received a drug that blocks BCL-2.

How is the study designed?

Allocation
N/A
Interventional study model
Single Group
Participant Group / Arm
Experimental: S65487 with azacitidine
Intervention / Treatment
Drug: S65487 and azacitidine

Participants receive both S65487 and azacitidine over a period of 4 weeks. S65487 is given through an intravenous (IV), which means it will be injected directly into a vein. Azacitidine can be given either through an injection under the skin (subcutaneous) or through an IV.

Keywords

Provided by Servier
Acute Myeloid Leukemia Dose escalation Phase I/II Azacitidine Combination Oncology
Additional Relevant MeSH Terms Glioma
Leukemia, Myeloid, Acute Neoplasms