Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

July 31, 2016

Study Completion Date

July 31, 2016

Conditions
Breast CancerOvarian CancerGynecological CancerHead and Neck CarcinomaNon-small Cell Lung CancerSmall Cell Lung CancerNon-squamous Cell Lung Cancer
Interventions
DRUG

PM01183 + paclitaxel +/- bevacizumab

"PM01183: 1 mg and 4 mg vials. Powder for concentrate for solution for infusion~paclitaxel: 6 mg/ml concentrate for solution for infusion~bevacizumab: 25 mg/ml concentrate for solution for infusion~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 prospectively selected cohort of patients"

Trial Locations (3)

Unknown

New York

Madrid

Bellinzona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PharmaMar

INDUSTRY