CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
ABI-009 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02009332
NCT02009332Phase 2Completed
CompareCT.gov

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

Aadi Bioscience, Inc.·interventional·Posted Dec 12, 2013·Updated Jun 8, 2021

In Brief

A Phase 2 clinical trial evaluating ABI-009 and Gemcitabine for Non-muscle Invasive Bladder Cancer (NMIBC). Completed, enrolled 21 participants across 2 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-muscle Invasive Bladder Cancer (NMIBC)
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 12, 2013
Enrollment StartApr 9, 2014
Primary CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 12.6 years ago

Interventions

ABI-009drug

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.

Gemcitabinedrug

Gemcitabine is administered after ABI-009 in the Phase 2 study.