Multi-Center Phase 2 Trial of Single-Agent Amrubicin as Second-Line Therapy in Patients With Advanced/Metastatic Refractory Urothelial Carcinoma
Multiple small phase II trials exploring a variety of agents as second-line therapy for
metastatic urothelial carcinoma have been performed. Overall, the most active of these
agents have shown response rates of approximately 10-20% . Currently, there are no FDA
approved agents for the second-line treatment of metastatic urothelial carcinoma.
The current study will explore the safety and activity of the novel anthracycline,
amrubicin, as second-line chemotherapy in patients with advanced urothelial carcinoma.
The primary objective will be to evaluate the activity (as determined by objective response
rate) of amrubicin as second-line chemotherapy in patients with metastatic urothelial
carcinoma. The secondary objectives will be to evaluate progression-free survival, survival
at 1 year, and the safety of amrubicin as second-line therapy in patients with metastatic
Subjects will receive amrubicin IV daily x 3 days, every 21-days, with prophylactic
granulocyte colony stimulating factor. This 21-day time period is referred to as a cycle.
Subjects will undergo repeat computed tomography (CT) scans after every 2 cycles. In the
absence of progressive cancer, or prohibitive side effects, subjects will receive up to 6
cycles of treatment with amrubicin.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Tumor measurements via CT chest, abdomen, and pelvis for restaging after every 2 cycles
Matthew D Galsky, MD
Mount Sinai School of Medicine
United States: Food and Drug Administration
|Mount Sinai Medical Center||New York, New York 10029|
|Indiana University Simon Cancer Center||Indianapolis, Indiana 46202|
|Banner MD Anderson Cancer Center||Gilbert, Arizona 85234|