ACP-196 in subjects with Relapsed or Refractory de Novo ABC DLBCL
Research type
Research Study
Full title
An Open-label, Phase 1b Study of ACP-196 in Subjects with Relapsed or Refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
IRAS ID
156164
Contact name
Simon Rule
Contact email
Sponsor organisation
Acerta Pharma BV
Eudract number
2014-001341-25
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 118717
Research summary
This study will look into the effects of an experimental drug called ACP-196. ACP-196 is a type of drug that blocks proteins inside cells that help cells live and grow. The specific protein blocked by ACP-196 is believed to help blood cancer cells live and grow. It is possible that ACP-196 may kill the cancer cells or stop them from growing. Patients who have a form of cancer called de novo Activated B-cell Subtype of diffuse large B-cell lymphoma (ABC DLBCL) will be invited to take part in this study.
The purpose of the study is to find out if the study drug, taken twice daily by mouth on an empty stomach, will slow or stop your cancer from getting worse and whether the study drug has side effects. The second purpose is to measure whether your tumour responds to the study medication.
Approximately 20 patients will be enrolled in this study at sites across the United States, Germany, and the UK. Men and women aged 18 years and above are eligible to take part in the study.
Participation in this study will last up to 14 months, and will include coming to the study centre approximately 20 times during the study. Patients will need to give blood and urine samples, and also bone marrow samples, on a number of different occasions during the study. Tumour samples taken before entry to the study will need to be checked by the sponsor (or designee) to confirm the presence of de Novo ABC DLBCL, and to check if there are any genetic defects in the cancer cells.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
14/SC/1317
Date of REC Opinion
18 Nov 2014
REC opinion
Further Information Favourable Opinion