S055746 : Phase I dose-escalation study of the orally administrered selective Bcl-2 inhibitor S055746 as monotherapy for the treatment of patients with Acute Myeloid Leukaemia (AML) or high or very high risk Myelodysplastic Syndrome (MDS)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaAcute Myeloid Leukaemia, Myelodysplasia, Chronic Myelogenous Leukaemia

Trial Overview Read MoreRead more

This phase I trial is assessing the oral administration of the drug S 055746 in patients with Acute Myeloid Leukaemia or Myelodysplastic Syndrome.
 

This trial is treating patients with Acute Myeloid Leukaemia, Myelodysplasia.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment, but your cancer has come back.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

You may be excluded from this trial if:

  • You have had certain treatments, surgical procedures or drugs.
  • You have a certain disease or psychological condition.
  • You have previously been treated (or are currently being treated) on a clinical trial.
  • You have been diagnosed with a prior or secondary type of cancer.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

Phase I dose-escalation study of the orally administrered selective Bcl-2 inhibitor S055746 as monotherapy for the treatment of patients with Acute Myeloid Leukaemia (AML) or high or very high risk Myelodysplastic Syndrome (MDS)

Commercial Sponsor

Servier

Summary

To determine the safety profile and tolerability of S 055746 and establish the recommended Phase II dose. Film-coated tablets containing 50 mg or 100mg of S055746. This trial is a dose escalation trial. A modified version of the Continual Reassessment Method (mCRM) will be used for dose allocation process. The first daily dose tested will be 100 mg, and then a panel of daily doses from 50 to 1000 mg could be tested according to the dose allocation process of the mCRM. Doses over 1000 mg and intermediate doses could be proposed depending on available results during the study. Treatment duration for the participant is until evidence of treatment failure, the occurrence of unacceptable toxicity, death, exercise of investigator discretion, withdrawal of consent or if clinically indicated after discussion between investigator and the sponsor on a case by case basis

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Malignant Haematology & Stem Cell Transplantation Service
Prahran
Ms Janet Andrew
j.andrew@alfred.org.au
03 9076 5281

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140