Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Weekly Paclitaxel, With or Without Bevacizumab, in Patients With Selected Advanced Solid Tumors
Clinical trial to determine the maximum tolerated dose (MTD) and the recommended dose (RD)
of PM01183 in combination with weekly paclitaxel, with or without bevacizumab. Once a
recommended dose is defined for the PM01183 and weekly paclitaxel combination, the
feasibility of adding bevacizumab to this combination will be explored in a selected cohort
of patients to characterize the safety profile and feasibility of this combination, to
obtain preliminary information on antitumor activity, to obtain preliminary information on
quality of life (QoL), to characterize the pharmacokinetics (PK) of this combination and to
detect major drug-drug PK interactions and PK/PD (pharmacokinetic/pharmacodynamic)
correlation and to conduct an exploratory pharmacogenomic(PGx) analysis in patients with
selected advanced solid tumors.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose (MTD) and the recommended dose (RD)
To determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with weekly paclitaxel, with or without bevacizumab, in patients with selected advanced solid tumors.
Around 24 months from the begining of the study
Yes
United States: Food and Drug Administration
PM1183-A-007-13
NCT01831089
September 2013
June 2016
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |