MK-8628 Haematologic Malignancy Trial
Research type
Research Study
Full title
A Phase IB Trial with MK-8628, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Subjects with Selected Haematologic Malignancies
IRAS ID
200558
Contact name
DAVID CUNNINGHAM
Contact email
Sponsor organisation
Oncoethix GmbH, subsidiary of Merck Sharp & Dohme Corp.
Eudract number
2015-005487-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 13 days
Research summary
Summary of Research
Haematologic malignancies are life-threatening cancers of the blood system causing the death of most of the subjects affected because of the lack of therapeutic options. The level of unmet medical need is very high and innovative new drugs are eagerly anticipated.
Accumulating studies reveal the critical roles of bromodomain extraterminal proteins (BET) in cancer development. There is increasing evidence in preclinical models that bromodomain (BRD) inhibition can result in antitumor activity against various illnesses, including Acute Myeloid Leukaemia (AML) and Diffuse Large B Cell Lymphoma (DLBCL).
It is known that in many haematologic malignancies, the cancer development is driven by the oncogene (gene changed that may cause the growth of cancer cells) c-Myc. It has been shown that BRD inhibition was frequently associated with c-Myc, and downstream targets down regulation which can lead to arresting of cell-cycle progression and apoptosis (programmed cell-death); cancer cells are selectively killed.
The study drug MK-8628 is a synthetic small molecule targeted to BRD 2, 3 and 4 of the BET proteins.
Taken together, preclinical data and results from the ongoing phase Ib haematologic study (MK-8628-001) have shown promising results and provide the rationale for further investigation of MK-8628 in subjects with selected haematologic malignancies.
Approximately 56 male/female subjects over the age of 18 with selected haematologic malignancies with the potential to respond to BET inhibition (AML and DLBCL) will be enrolled in this phase Ib open-label study which will last approximately 20 months. The purpose of this study is to determine the recommended dose for phase II studies. This study will focus on the evaluation of a twice-daily (BID) regimen.
Subjects will receive MK-8628 orally beginning on Day 1 of each 3-week dosing cycle.The study is funded by Merck Sharp & Dohme Limited and will take at 1 study centre in the UK.
Summary of Results
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REC name
London - Westminster Research Ethics Committee
REC reference
16/LO/0676
Date of REC Opinion
31 May 2016
REC opinion
Further Information Favourable Opinion