Phase I/II trial of S65487 plus azacitidine in acute myeloid leukaemia

• Research type

  Research Study

• Full 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

• IRAS ID

  288472

• Contact name

  Jenny O'Nions

• Contact email

  jenny.o'nions@nhs.net

• Sponsor organisation

  IRIS, Servier France

• Eudract number

  2020-003061-19

• Clinicaltrials.gov Identifier

  46999, CPMS

• Duration of Study in the UK

  3 years, 1 months, 19 days

• Research summary

  This study is a Phase I/II trial for patients with Acute Myeloid Leukaemia (AML), who are elderly or not fit enough to receive intensive treatment. The Bcl-2 (anti-apoptotic) protein is present in normal healthy cells and helps regulate cell turnover by triggering unhealthy cells to die (apoptosis). In some cancers, including AML, Bcl-2 is over-expressed, and cancer cells remain alive and able to continue to divide and proliferate. Inhibiting Bcl-2 leads to death of the cancer cells. In this trial, we are assessing the efficacy of a novel Bcl-2 inhibitor S65487, combined with a standard treatment shown to be effective in AML (azacitidine) in adult patients with previously untreated AML, who are elderly and so not fit enough for intensive treatment.\n\nThis study involves a Dose Escalation phase (increasing the dose to identify the highest dose of S65487 that can be safely given with azacitidine) and Dose Expansion phase (confirming the optimal dose and checking its safety and potential efficacy). The principle aim of this trial is to check the safety of S65487 and its acceptability in patients with AML to determine the optimal dose. There will also be an initial check of how effective this drug is against the patient’s cancer.\n\nApproximately 21 patients will be given weekly intravenous infusions of S65487 in groups of 3 to 9 patients per dose tested. Cycles are 4- weekly and the effectiveness of S65487 in treating the patients’ cancer will be assessed. Once the optimal dose (called the recommended phase 2 dose) has been confirmed, an expansion trial of an additional 21 patients will be conducted to further check the safety and potential efficacy of the drug at this dose. \n\n

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  20/EE/0295

• Date of REC Opinion

  5 Feb 2021

• REC opinion

  Further Information Favourable Opinion