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Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia

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Servier Protocol Code: CL1-64315-004 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT04629443 EudraCT Number: 2019-004896-38

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How to participate to the 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 don’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 7 locations

Study description

This study was done to test a new anticancer drug, S64315, combined with another anticancer drug, azacitidine, in participants with acute myeloid leukaemia (AML).

AML is a rapidly progressing cancer of the blood and bone marrow. In AML, the cancer cells have higher amounts of certain proteins such as Mcl-1 (myeloid cell leukaemia 1). These Mcl-1 proteins promote the survival of cancer cells.

S64315 is a drug that blocks Mcl-1 proteins. This blocking leads to the death of the cancer cells.

In this study, S64315 was combined with another drug called azacitidine. S64315 and azacitidine are referred to here as ‘study drugs’. Azacitidine is already approved for the treatment of AML. Azacitidine works by interacting with the DNA (genetic material), helping the destruction of cancer cells. It was hoped that by combining S64315 and azacitidine, their actions on the cancer cells might be more effective.

Two parts were planned in this study. The main objective of the first part was to look at the safety of S64315 when given in combination with azacitidine. The main objective of the second part was to assess how many patients showed no signs of AML after treatment with S64315 in combination with azacitidine.

Official title: Phase I/II, International, Multicentre, Open-label, Non-randomised, Non-comparative, Study Evaluating the Safety, Tolerability and Clinical Activity of Intravenously Administered S64315, a Selective Mcl-1 Inhibitor, in Combination With Azacitidine in Patients With Acute Myeloid Leukaemia (AML)
Results
English (USA)
Conditions
Acute Myeloid Leukaemia
Interventions / Treatments
  • S 64315 (also referred as MIK665) and azacitidine
Other study id numbers
  • CL1-64315-004

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sexes

Male/Female

Accepts Healthy Volunteers

No

To take part, participants had to:

  • Be at least 18 years old.
  • Have AML that:
    • returned after improvement (relapsed) or did not respond to any treatment (refractory) and for which there was no other approved therapy that could be prescribed.

or

    • was secondary to a condition called myelodysplastic syndrome, in which the bone marrow does not make enough healthy blood cells.

Participants could not take part in the study if they:

  • Had received anticancer treatment with medicines or radiation within two weeks before starting the study.
  • Had a cancer other than AML.

How is the study designed?

Allocation
N/A
Interventional study model
Single Group
Participant Group / Arm
Experimental: S64315 (also known as MIK665) with azacitidine

All participants received a combination of S64315 and azacitidine.

Intervention / Treatment
Drug: S64315 (also known as MIK665)

S64315 was given through infusion (injection given slowly) into a vein at doses ranging from 25 milligrams (mg) to 190 mg. Infusion time was at least 2 hours.

Drug: azacitidine

Azacitidine was given as an injection under the skin at a fixed dose of 75 mg/m².

Keywords

Provided by Servier
Acute Myeloid Leukaemia Oncology Mcl-1 inhibitor Azacitidine Combination Phase I/II International Safety Maximum tolerated dose
Additional Relevant MeSH Terms Glioma
Leukemia, Myeloid, Acute Neoplasms