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

NCT02009332 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-06-08

Study results available
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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

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Aadi Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • James McKiernan, MD · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-09
Primary Completion
2019-12-01
Completion
2019-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02009332 on ClinicalTrials.gov