PM01183 - CORAIL Trail
Research type
Research Study
Full title
Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) versus Pegylated Liposomal Doxorubicin or Topotecan in Patients with Platinum-resistant Ovarian Cancer (CORAIL Trial).
IRAS ID
171246
Contact name
Shelagh Main
Contact email
Sponsor organisation
Pharma Mar S.A
Eudract number
2014-005251-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 5 days
Research summary
This is a Phase III Randomised Clinical Trial to determine a difference in progression-free-survival (PFS) between lurbinectedin (PM01183) and pegylated liposomal doxorubicin (PLD) or topotecan in platinum-resistant ovarian cancer patients according to the Response Evaluation Criteria in Solid Tumors (RECIST).
PM01183 is a new chemical entity that induces double-strand DNA breaks through binding to the DNA minor groove. As per COMPARE analysis, it does not have an overlapping mechanism of action with other 98 standard cytotoxic agents.
Participants in this study shall be aged ≥ 18 years and participants will be recruited through their current healthcare team. Sites in the UK will be hospital based. Participants shall be in this study for approxomately 42 months. The participants will undergo a Pre-treatment; Treatment and Follow-up. The recruitment processes are described in the Informed Consent Forms - attached with this submission.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/0984
Date of REC Opinion
16 Jun 2015
REC opinion
Favourable Opinion