Acelarin(NUC-1031) + Carboplatin for recurrent ovarian cancer
Research type
Research Study
Full title
Phase IB open label study to assess the safety, pharmacokinetics and clinical activity of Acelarin (NUC-1031) given on days 1 & 8 with carboplatin on day 1, every three weeks for 6 cycles in participants diagnosed with recurrent ovarian cancer.
IRAS ID
147091
Contact name
Sarah Blagden
Contact email
Sponsor organisation
Joint Research Compliance Office, Imperial College Healthcare NHS Trust
Eudract number
2014-002006-21
Clinicaltrials.gov Identifier
14HH2122, Joint Research Compliance Office Reference number
Research summary
Acelarin and carboplatin combination is a new experimental treatment for ovarian cancer which reappear after standard chemotherapy. Chemotherapy is the name for drug treatments to kill or control the growth of cancer cells. Although there is some evidence from laboratory and clinical studies that Acelarin is effective in the treatment of ovarian cancer, it has not yet been tested in combination with another chemotherapy drug. So this combination treatment is classed as a first in human study(Phase1B).
The aim of the study is to investigate whether adding Acelarin to carboplatin can improve the benefits of chemotherapy. Other purposes are to find out whether Acelarin is safe to give with carboplatin, to identify the correct dose of Acelarin when given with carboplatin and establish how effective the combination is at treating ovarian cancer. This study is also designed to enable us to find out whether Acelarin adds further benefit, over and above that achieved by carboplatin alone, when treating ovarian cancer.
Acelarin and carboplatin combination will be given in six cycles. Each cycle is 3 weeks long. On first day of first week of each cycle (day1), selected study participants will receive one dose of both Acelarin and Carboplatin chemotherapy. Following this, the study participant will receive a second dose of Acelarin alone on first day of second week (day 8). This schedule will be repeated every 3 weeks for 6 cycles.REC name
London - West London & GTAC Research Ethics Committee
REC reference
14/LO/1197
Date of REC Opinion
18 Sep 2014
REC opinion
Further Information Favourable Opinion