Phase 1b Study in Subjects with Multiple Myeloma ACE-MY-001
Research type
Research Study
Full title
An Open-label, Phase 1b Study of ACP-196 in Subjects with Multiple Myeloma
IRAS ID
167913
Contact name
Mamta Garg
Contact email
Sponsor organisation
Acerta Pharma BV
Eudract number
2014-003587-21
Clinicaltrials.gov Identifier
118717, IND number
Duration of Study in the UK
1 years, 9 months, 1 days
Research summary
This is a Phase 1b Clinical trial testing a new experimental drug, called ACP-196 in adults with Multiple Myeloma (MM). MM is a type of bone marrow cancer.
Approximately 40 participants will be enrolled in this study across the United States and Europe.
This is an open-label study, meaning that both the participant and the researchers will know which treatment the participant is receiving. Participants will be equally
randomised (selected by chance) (1:1 ratio) into 2 groups to receive ACP-196, with and without dexamethasone:
• Group 1: ACP-196 100 mg twice per day (BID) continuously
• Group 2: ACP-196 100 mg BID continuously and dexamethasone 40 mg once weekly.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.The purpose of the study is to find out if the study drug, given twice daily by mouth, with or without dexamethasone is safe. The second purpose is to measure whether the cancer responds to the study drug/dexamethasone.
The study consists of a screening visit (up to 21 days), treatment up to 12 cycles (each cycle is 28 days), Early Termination/Safety Follow up (FU) within 30 days of last dose.
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 and X-rays.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0211
Date of REC Opinion
5 Aug 2015
REC opinion
Further Information Favourable Opinion