Phase 1 trial with Bcl-2 inhibitor S55746 in t(11:14) multiple myeloma
Research type
Research Study
Full title
Phase I dose-escalation study of oral administration of the selective Bcl2 inhibitor S55746 in patients with refractory or relapsed Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma.
IRAS ID
181255
Contact name
Marta Garcia
Contact email
Sponsor organisation
Servier Research and Development Limited
Eudract number
2013-003779-36
ISRCTN Number
ISRCTN04804337
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
This trial is testing a new drug for the treatment of blood and bone marrow cancers called S55746, for the first time in humans. The main aim of this trial is to test the safety of S55746 and to determine the ‘Maximum Tolerated Dose’ (MTD). Secondary aims include assessment of the effectiveness of S55746 as a treatment and what happens to S55746 in the body.
To determine the MTD small groups of patients will be given increasing doses of S55746, called the ‘dose escalation’ phase. The MTD will then be confirmed in a ‘dose expansion’ phase in a larger group of patients. The UK will only be involved in the dose expansion phase and the inclusion of patients with multiple myeloma with a specific genetic change called t(11:14), found to be most sensitive to S55746.
The dose escalation phase includes patients with B-cell Non-Hodgkins Lymphoma (NHL) and Chronic Lymphocytic Leukaemia (CLL). The UK is not involved in this part of the study.
S55746 is taken orally, once a day, in repeating 21 day cycles. Like all patient included in this trial, myeloma patients will undergo at least 2 cycles of treatment, unless safety concerns arise. Treatment will continue as long as the disease does not progress and S55746 is sufficiently well tolerated. During each cycle safety will be assessed. At the end of each cycle the patients will undergo specific blood and urine tests to assess whether S55746 has had any impact on the patient’s myeloma.
S55746 is a ‘Bcl-2 inhibitor’. A family of proteins called Bcl-2 are involved in signalling to a cell that it should grow. In blood and bone marrow cancers, Bcl-2 is found at higher levels than normal. By blocking Bcl-2, S55746 inhibits the instruction to grow and instead triggers the cell to die.
REC name
London - Central Research Ethics Committee
REC reference
16/LO/0068
Date of REC Opinion
29 Jan 2016
REC opinion
Favourable Opinion