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NCT01331824 · ClinicalTrials.gov registry record · Phase 2
Trial of Amrubicin as Second-Line Therapy in Patients With Advanced/Metastatic Refractory Urothelial Carcinoma
A Phase 2 study, sponsored by Matthew Galsky.
- Terminated
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT01331824: Clinical Trial Phase 2 study, sponsored by Matthew Galsky.
NCT01331824 is a Phase 2 study that was terminated before completion, run by Matthew Galsky. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01331824, a Phase 2 study, was terminated before completion, sponsored by Matthew Galsky.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine in subjects with metastatic measurable bladder cancer (or urothelial cancers originating elsewhere in the genitourinary tract) who have progressed on 1 prior chemotherapeutic regimen the objective response rate to treatment with amrubicin. The secondary objectives will be to evaluate progression-free survival, survival at 1 year, and the safety of amrubicin as second-line therapy in patients with metastatic urothelial carcinoma.
Primary Outcome
Response to treatment based on tumor measurements via CT chest, abdomen, and pelvis for restaging after every 2 cycles. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Interventions
- DRUG Amrubicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2011-02 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
Why NCT01331824 stopped before completion
NCT01331824 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Amrubicin is the first listed.
NCT01331824 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01331824 about?
NCT01331824 is a clinical study titled "Trial of Amrubicin as Second-Line Therapy in Patients With Advanced/Metastatic Refractory Urothelial Carcinoma". The primary objective of this study is to determine in subjects with metastatic measurable bladder cancer (or urothelial cancers originating elsewhere in the genitourinary tract) who have progressed on 1 prior chemotherapeutic regimen the objective response rate to treatment with amrubicin. The seco...
What is the current status of trial NCT01331824?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2011-02. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01331824?
The interventions under investigation include: Amrubicin (DRUG).
Who is sponsoring clinical trial NCT01331824?
This trial is sponsored by Matthew Galsky, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01331824's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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