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Home » Find Clinical Trials » Dose-escalation Study of Oral Administration of S 055746 in Patients With Acute Myeloid Leukaemia or Myelodysplastic Syndrome

Dose-escalation Study of Oral Administration of S 055746 in Patients With Acute Myeloid Leukaemia or Myelodysplastic Syndrome

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Servier Protocol Code: CL1-055746-002 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT02920541 EudraCT Number: 2014-002559-24

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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 5 locations

Study description

This study is needed to test the study drug, S055746, in patients with Acute Myeloid Leukaemia or Myelodysplastic Syndrome. Specifically, this study focusses on patients whose cancer has come back after treatment, or for whom the standard treatment did not work.

Acute Myeloid Leukaemia and Myelodysplastic Syndrome are cancers of the blood and bone marrow (the spongy tissue inside bones where blood cells are made). In these cancers, 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.

S055746 is a drug that blocks BCL-2 proteins. By blocking BCL-2 proteins, this drug could cause cancer cells to die.

The main goals of this study were:

  • To test the safety of S055746.
  • To find the maximum tolerated dose (MTD) of S055746. The MTD is the highest dose of the drug that can be taken without too much risk.
Official title: Phase I Dose-escalation Study of the Orally Administered Selective Bcl-2 Inhibitor S 055746 as Monotherapy for the Treatment of Patients With Acute Myeloid Leukaemia (AML) or High or Very High Risk Myelodysplastic Syndrome (MDS)
Results
English (USA)
English (USA)
Conditions
Acute Myeloid Leukaemia (AML) Myelodysplastic Syndrome (MDS)
Interventions / Treatments
  • S 055746
Other study id numbers
  • CL1-055746-002

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 aged 18 years or older.
  • Have been diagnosed with Acute Myeloid Leukaemia or Myelodysplastic syndrome and:
    • Have a cancer that came back after previous treatment and for which standard treatment couldn’t be used anymore.
    • Have a cancer that did not respond to the standard treatment.
  • For participants with AML that were aged 65 years or older, be too frail to support intensive treatment and have not previously been treated for Acute Myeloid Leukaemia.

 

Participants could not take part in the study if they:

  • Had previously received a drug that blocks BCL-2.
  • Had received anticancer treatment in the 2 weeks before starting the study.
  • Had undergone treatment with radiation within 4 weeks or surgery within 3 weeks before starting the study.

How is the study designed?

Allocation
N/A
Interventional study model
Single Group
Participant Group / Arm
Experimental: S055746

All participants took the same study drug, S55746, available as oral 100 mg tablets. Participants took the study drug during time periods called “cycles”. Participants took oral tablets of S55746 once daily during 21-days cycles. There was no interruption of treatment between cycles.

The treatment was maintained as long as the cancer did not progress and the participants did not have too severe side effects.

Intervention / Treatment
Drug: S055746

Keywords

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