10 julio 2015

PM01183 Inicía Fase II en Pacientes con Tumores Solidos en Estados Unidos .

Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors .

Verified July 2015 by PharmaMar

A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors to assess the antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), in the following advanced solid tumors small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing's family of tumors (EFTs) .

Estimated Enrollment: 225
Study Start Date: July 2015
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure) .

Responsible Party: PharmaMar
Health Authority: United States: Food and Drug Administration .