drugset / Trial / NCT01282463

Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma

NCT01282463

Phase 2 Completed 148 enrolled Eli Lilly and Company
RandomizedParallel-groupOpen-labelTreatment

Summary

This multicenter trial will enroll participants with metastatic transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis who have had disease progression on first-line platinum-based chemotherapy regimens. Participants will be enrolled into 1 of 3 treatment arms: docetaxel; docetaxel and ramucirumab; or docetaxel and icrucumab.

Timeline

Start
2011-04
Primary completion
2015-02
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Icrucumab Monoclonal antibody 12 mg/kg Intravenous
Subject Ramucirumab Monoclonal antibody 10 mg/kg Intravenous