H-16848 - Phase II Pilot Study With Correlative Markers of Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Sustained stable disease is considered to be clinically important. Hence, 4-month freedom from progression (FFP) (Stable disease + Partial response + Complete response) is chosen as the primary end-point instead of response rate.
Seth P. Lerner, M.D.
Baylor College of Medicine
United States: Institutional Review Board
|Baylor College of Medicine||Houston, Texas 77030|