NCT02009332

Phase 1/2 Study of ABI-009 in Nonmuscle Invasive Bladder Cancer

A Combined Phase 1 and Phase 2 Study of Albumin-bound Rapamycin Nanoparticles (Nab-rapamycin, ABI-009) in the Treatment of BCG Refractory or Recurrent Nonmuscle Invasive Transitional Cell Bladder Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Aadi Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Purpose of this study is to determine appropriate dosing of ABI-009 and evaluate the safety and anti-tumor activity of ABI-009 in treatment of non-muscle invasive bladder cancer

Conditions

• Non-muscle Invasive Bladder Cancer (NMIBC)

Interventions

Type	Name	Description
DRUG	ABI-009	ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm.
DRUG	Gemcitabine	Gemcitabine is administered after ABI-009 in the Phase 2 study.

Timeline

• Start date: 2014-04-09
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2013-12-12
• Last updated: 2021-06-08
• Results posted: 2021-06-08

Locations

2 sites across 1 country: United States