An Immunopharmacodynamic Phase 0/I Study of Rapamycin in Patients Undergoing Radical Cystectomy for Bladder Cancer
This is a presurgical clinical trial which aims to understand the biologic activity of TORC1
inhibition and safety in patients with bladder cancer. In this presurgical setting, paired
PMBCs and tumor tissue is evaluated before and after exposure to rapamycin to address target
specificity, drug delivery, physiologic effects on tumor growth and apoptosis, and
correlation of biomarkers with clinical activity.
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Tissue pharmacodynamic (PD) response to TORC1 inhibition
PD response defined by significant phospho rpS6 Kinase 1 (S6K1) inhibition (comparing post-treatment to baseline).
Robert S Svatek, MD,MSCI
UT Health Science Center San Antonio
United States: Food and Drug Administration
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