NCT02009332View on ClinicalTrials.gov

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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

April 9, 2014

Primary Completion Date

December 1, 2019

Study Completion Date

December 1, 2019

Conditions
Non-muscle Invasive Bladder Cancer (NMIBC)
Interventions
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.

Trial Locations (2)

10032

Columbia University Medical Center, New York

37232

Vanderbilt University Medical Center, Nashville

Sponsors
All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Aadi Bioscience, Inc.

INDUSTRY