(GU12-160) A Randomized Phase 2 Study Comparing Docetaxel Alone to Docetaxel in Combination with OGX-427 in Patients with Relapsed or Refractory Metastatic Urothelial Carcinoma after Receiving a Platinum-containing Regimen
Description: 

This is a randomized, open-label trial to evaluate whethersuppression of Hsp27 production using OGX-427, a secondgenerationantisense oligonucleotide (ASO), in combination withdocetaxel can prolong survival time compared to docetaxel alonein participants with locally-advanced or metastatic urothelialcarcinoma (UC) that are relapsed or refractory after receiving aplatinum-containing regimen. A total of 200 subjects will beenrolled. One interim analysis will occur to determine whether tostop study enrollment based on survival futility. The trial will notbe stopped early based on efficacy.

Study Number: 

I 240213

Phase: 
II
Principal Investigator: 
ClinicalTrials.Gov ID: 
NCT01780545

To inquire about participating in these studies, call 1-877-ASK-RPCI (1-877-275-7724) or e-mail askrpci@roswellpark.org.