PM01183 in Selected Advanced Solid Tumors
Research type
Research Study
Full title
A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
IRAS ID
184117
Contact name
Maria Martiánez Calderon
Contact email
Sponsor organisation
Pharma Mar, S.A.
Eudract number
2014-003773-42
Duration of Study in the UK
3 years, 2 months, 28 days
Research summary
Lurbinectedin is a new chemical entity. It was selected for clinical development due to its in vitro and in vivo promising cytotoxic activity, particularly in most of the tumour types selected in this clinical study. This clinical trial has been designed to establish or confirm the proof of concept of Lurbinectedin anticancer activity in several difficult-to-treat tumours for their potential further development.
The patient will receive the study drug at a dose of 3.2 mg/m2 through an intravenous infusion on day 1 every three weeks, whilst it is considered to be in his/her benefit, such as no progressive disease being observed, and no unacceptable toxicities occurring. The patient must meet re-treatment criteria prior to any new cycle, and no more than two dose reductions are allowed in case of toxicity.
Disease response assessment will be performed before study entry, and every two cycles until cycle six and every three cycles, thereafter. In patients who discontinued treatment without progression, disease assessment will be done every two months during the first six months and every three months thereafter, until disease progression, start of a new anti-tumour therapy, death or until the date of study termination, whichever occurs first. According to current state-of-the-art guidelines, this assessment will consist of a helical contrast-enhanced CT scan or gadolinium enhanced MRI.
Toxicities will be recorded and graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) v 4.0 throughout study treatment, at the end of the study treatment, and then at the time of the follow up visits until resolution/stabilization of existing toxicities or start of a new anticancer therapy, whichever occurs first.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
16/EM/0173
Date of REC Opinion
14 Jun 2016
REC opinion
Further Information Favourable Opinion