Phase 1b/2 Participants with Waldenström Macroglobulinemia ACE-WM-001
Research type
Research Study
Full title
An Open-label, Phase 1b/2 Study of ACP-196 in Subjects with Waldenström Macroglobulinemia
IRAS ID
165426
Contact name
Roger Owen
Contact email
Sponsor organisation
Acerta Pharma BV
Eudract number
2014-003212-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
This is a Phase 1b/2 Clinical Trial testing a new experimental drug, called, ACP-196 in adults with Waldenström Macroglobulinemia (WM). WM is a cancer affecting B cells, a type of white blood cell.
Approximately 88 participants will be enrolled in this study across the United States and Europe.
This is an open-label study, meaning that both the participants and the researchers will know which treatment the participants are receiving.
ACP-196 is a type of drug that blocks proteins inside cells that help cells live and grow. The specific protein blocked by the study drug is believed to help blood cancer cells live and grow. It is possible that the study drug may kill the cancer cells or stop them from growing. In this study, participants with Waldenström Macroglobulinemia (WM), who have relapsed or failed to respond to their anticancer therapy ( Phase 2 part of study) or have previously not been treated for their WM and do not wish to receive chemotherapy may be eligible to enter the study (a smaller number of participants Phase Ib of the study).
The purpose of the study is to find out if the study drug, given twice daily by mouth, will slow or stop cancer from getting worse and whether the study drug has side effects. The second purpose is to measure whether the cancer responds to the study drug.
The study consists of a screening visit (up to 21 days), treatment up to 24 cycles (each cycle is 28 days), Follow up (FU) within 30 days of last dose, Long Term FU (every 3 months) .
The following assessments will be included:physical exam, vital signs (BP, pulse, respirations and temperature), weight, Eastern Cooperative Oncology Group (ECOG), Electrocardiogram (ECG), Blood and urine sampling, bone marrow biopsy and aspirate, Computerised Tomography (CT) scans.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
15/YH/0125
Date of REC Opinion
24 Apr 2015
REC opinion
Further Information Favourable Opinion