drugset / Trial / NCT00722553

Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder

NCT00722553

Phase 2 Completed 30 enrolled Acrotech Biopharma Inc.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of advanced or metastatic bladder cancer. The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this patient population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this patient population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body).

Timeline

Start
2008-07
Primary completion
2011-04
Completion
2011-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Pralatrexate Other / unclassified 100 mg/m2 Intravenous
Subject Pralatrexate Other / unclassified 120 mg/m2 Intravenous
Subject Pralatrexate Other / unclassified 150 mg/m2 Intravenous
Subject Pralatrexate Other / unclassified 190 mg/m2 Intravenous