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NCT02009332 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Study of ABI-009 in Nonmuscle Invasive Bladder Cancer
A Phase 1 study, sponsored by Aadi Bioscience.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT02009332: Completed Phase 1 study, sponsored by Aadi Bioscience.
NCT02009332 is a Phase 1 study that has completed, run by Aadi Bioscience. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02009332, a Phase 1 study, has completed, sponsored by Aadi Bioscience.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study 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
Primary Outcome
The primary endpoint of the Phase 1 study is DLT following intravesical administration of ABI-009 in patients with BCG refractory or recurrent nonmuscle-invasive transitional cell carcinoma (TCC) of the bladder to identify maximum deliverable dose (MDD). Systemic DLT will be defined as any grade systemic toxicity using the NCI CTCAE version 4.0. Local dose limiting toxicity was defined as grade 3 or 4 bladder toxicity (hematuria, dysuria, urinary retention, urinary frequency/urgency, or bladder
Interventions
- DRUG Gemcitabine
- DRUG ABI-009
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2014-04-09 |
| Est. Completion | 2019-12-01 |
| Phase | Phase 1 |
What the finished NCT02009332 record still lists
NCT02009332 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Gemcitabine is the first listed.
NCT02009332 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02009332 about?
NCT02009332 is a clinical study titled "Phase 1/2 Study of ABI-009 in Nonmuscle Invasive Bladder Cancer". 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
What is the current status of trial NCT02009332?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2014-04-09. Estimated completion is 2019-12-01.
What interventions are being tested in trial NCT02009332?
The interventions under investigation include: Gemcitabine (DRUG), ABI-009 (DRUG).
Who is sponsoring clinical trial NCT02009332?
This trial is sponsored by Aadi Bioscience, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02009332's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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