520-311 The FACTOR Study
Research type
Research Study
Full title
A Multinational, Randomized, Open-Label Phase 3 Study of Filanesib (ARRY-520)+ Carfilzomib Versus Single-Agent Carfilzomib in Patients With Advanced Multiple Myeloma
IRAS ID
161301
Contact name
Heather Oakervee
Contact email
Sponsor organisation
Array BioPharma Inc.
Eudract number
2014-001052-39
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
An unmet medical need exists for patients with multiple myeloma whose disease has progressed despite treatment with various different therapies, including therapies that are newer to the market.
This need may be addressed with new drugs such as Filanesib and Carfilzomib due to the way they work.
Both Filanesib and Carfilzomib work by binding to and suppressing certain proteins/enzymes that are present in cancer cells and help them to survive.
The treatments then inhibit the activity of these proteins/enzymes delaying the progress of the disease and allowing the growth of healthy cells.
To be eligible to participate in the study patients must be over 18 years of age and have a confirmed diagnosis of multiple myeloma for which they must have received at least 2 and no more than 6 previous types of treatment including Bortezomib.
The study will consist of a 4 week screening phase followed by several 28 day treatment cycles for patients who pass the screening phase.
Study assessments will include: Physical examinations, blood and urine tests, bone marrow aspirate or biopsy and radiological scans.REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/1836
Date of REC Opinion
2 Dec 2014
REC opinion
Further Information Favourable Opinion