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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 is a Phase 1 study that was terminated before completion, run by Altor BioScience. The registered enrollment target is 12 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01625260
The ClinicalTrials.gov registry entry for NCT01625260 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Altor BioScience, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Gemcitabine is the first listed.
NCT01625260 reports 0 study locations.
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.
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