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Phase I Study of S64315 Administred Intravenously in Patients With Acute Myeloid Leukaemia or Myelodysplastic Syndrome

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Servier Protocol Code: CL1-64315-001 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT02979366 EudraCT Number: 2016-003768-38

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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 9 locations

Study description

The study was done to test a new anticancer drug calledS64315. S64315 blocks the Mcl-1 protein, which promotes tumour-cell survival. This blocking leads to the death of the cancer cells.

Therefore, researchers have expected that S64315 could be effective in different kinds of blood cancers, including Acute Myeloid Leukaemia (AML) and Myelodysplastic Syndrome (MDS).

The main objectives of this study were:

  • To look at the safety of the study drug.
  • This dose helps to find the recommended dose (dose that is both safe and effective for patients).
Official title: Phase I, International, Multicentre, Open-label, Non-randomised, Non-comparative Study of Intravenously Administered S64315, a Mcl-1 Inhibitor, in Patients With Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS)
Results
English (USA)
English (USA)
Conditions
Acute Myeloid Leukaemia (AML) Myelodysplastic Syndrome (MDS)
Interventions / Treatments
  • S64315 once a week
  • S64315 twice a week
Other study id numbers
  • CL1-64315-001

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 had to:

  • Be 18 years of age or older.
  • Have been diagnosed with a kind of blood cancer called AML or MDS that either:
    • Came back after previous treatment and for whom no other treatment could be used anymore.
    • Did not respond to any treatment.

Or

    • Be aged 65 years or older, be too frail to support intensive treatment and have not previously been treated for AML.

Participants could not take part in the study if they:

  • Had a cancer other than AML or MDS.
  • Had previously received a drug that blocks Mcl-1.

How is the study designed?

Allocation
Non-randomized
Interventional study model
Single Group
Participant Group / Arm
Experimental: S64315 once a week

Participants received S64315 through an IV infusion (injection given slowly) into a vein for 30 minutes to 3 hours once a week in a 21-day cycle, starting with a dose of 50 mg. As the study progressed, the infusion time and dosing schedule may have been adjusted based on new information.

Intervention / Treatment
Drug: S64315 (also known as MIK665)
Participant Group / Arm
Experimental: S64315 twice a week

Participants received S64315 through an IV infusion into a vein for 30 minutes to 3 hours twice a week in a 28-day cycle, starting with a dose of 50 mg. As the study progressed, the infusion time and dosing schedule may have been adjusted based on new information.

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

Keywords

Additional Relevant MeSH Terms Glioma
Leukemia, Myeloid, Acute Myelodysplastic Syndromes