Gemcitabine, Cisplatin, Plus Lenalidomide as First-line Therapy for Patients With Metastatic Urothelial Carcinoma
Status:
Terminated
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
The primary objectives of this study are (Phase 1) to determine in subjects with unresectable
or metastatic bladder cancer who have never had chemotherapy, the dose of lenalidomide that
is well-tolerated when given in combination with gemcitabine plus cisplatin and (Phase 2) to
study this recommended dose in subjects to evaluate progression-free survival at 1 year. The
secondary objectives will be to determine the objective response rate to treatment, and the
safety of combination therapy with gemcitabine, cisplatin and lenalidomide as well as to
evaluate lenalidomide as maintenance treatment in subjects achieving objective response or
stable disease.