Phase I study of PM01183 with cisplatin in advanced solid tumors.
Research type
Research Study
Full title
“Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Cisplatin in Patients with Advanced Solid Tumors“
IRAS ID
139923
Contact name
Martin Forster
Contact email
Sponsor organisation
Pharma Mar S.A. Sociedad Unipersonal
Eudract number
2013-003362-13
Clinicaltrials.gov Identifier
Research summary
This is a phase I study of a commonly used oncology drug (cisplatin) in combination with an experimental drug (PM01183). The aim of this study is to define the Maximum Tolerated Dose and the Recommended dose of this combination, with or without aprepitant (an antiemetic drug commonly used). We will use a fixed dose of cisplatin (60 mg/m2) and will escalate the dose of PM01183.
Patients will be enrolled in two groups: antiemetic aprepitant will be administered in one and no aprepitant will be allowed in the other. In each group, patients will be enrolled in cohorts of 3 patients at each dose level. In case no dose limiting toxicities (DLTs) are found, dose level will be escalated according to the protocol. Depending on the toxicities found at each dose level, cohorts might be expanded at each dose level. All evaluable patients within a dose level must be followed for at least one full cycle before dose escalation. The Recommended dose for each group will be the dose level immediately below the maximum tolerated dose, which will be the lowest dose level explored at which one third or more of evaluable patients have an unacceptable toxicity.
At least nine evaluable patients will be treated at the RD Level to evaluate its tolerability and feasibility.
According to preclinical studies, we believe that the combination of both dugs might be beneficial for the patients. Patients will remain on treatment whilst their disease remains controlled, unacceptable toxicity arises or in case patient withdraws his/her consent.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
14/NE/0010
Date of REC Opinion
11 Feb 2014
REC opinion
Further Information Favourable Opinion