drugset / Trial / NCT00722553
Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |