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NCT01625260 · ClinicalTrials.gov registry record · Phase 1
A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer
A Phase 1 study, sponsored by Altor BioScience.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01625260: Clinical Trial Phase 1 study, sponsored by Altor BioScience.
NCT01625260 is a Phase 1 study that was terminated before completion, run by Altor BioScience. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01625260, a Phase 1 study, was terminated before completion, sponsored by Altor BioScience.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of ALT-801 combined with gemcitabine for patients who have BCG failure (defined as refractory, relapsing or intolerant), non-muscle invasive bladder cancer and refuse or are not medically fit to undergo a radical cystectomy recommended by the participating urologist as the standard next therapy per urologic guidelines. The purpose of this study is to confirm the safety and tolerability of a well-tolerated dose level of ALT-801, to determine the Recommended Dose level (RD) and characterize the immunogenicity of ALT-801 combined with gemcitabine in treated patients. The anti-tumor responses will also be assessed.
Primary Outcome
Confirmation of the safety and tolerability (dose limiting toxicity count) of ALT-801 combined with gemcitabine.
Interventions
- DRUG Gemcitabine
- BIOLOGICAL ALT-801
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-03-30 |
| Est. Completion | 2018-03-08 |
| Phase | Phase 1 |
Why NCT01625260 stopped before completion
NCT01625260 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Gemcitabine is the first listed.
NCT01625260 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01625260 about?
NCT01625260 is a clinical study titled "A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer". This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of ALT-801 combined with gemcitabine for patients who have BCG failure (defined as refractory, relapsing or intolerant), non-muscle invasive bladder cancer and refuse or are not medically fit to undergo a radical cystec...
What is the current status of trial NCT01625260?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2012-03-30. Estimated completion is 2018-03-08.
What interventions are being tested in trial NCT01625260?
The interventions under investigation include: Gemcitabine (DRUG), ALT-801 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01625260?
This trial is sponsored by Altor BioScience, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01625260's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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