drugset / Trial / NCT00788099

Study of Plitidepsin in Combination With Sorafenib or Gemcitabine in Patients With Advanced Solid Tumors or Lymphomas

NCT00788099

Phase 1 Completed 45 enrolled PharmaMar
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Plitidepsin in Combination with Sorafenib or Gemcitabine in Patients with Advanced Solid Tumors or Lymphomas to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of plitidepsin in combination with sorafenib or gemcitabine in patients with advanced solid tumors or lymphomas.

Timeline

Start
2008-12
Primary completion
2011-06
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule Intravenous
Subject Plitidepsin Peptide Intravenous
Subject Sorafenib Small molecule Oral

Indications