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NCT01698281 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Trial of AEZS-108 in Chemotherapy Refractory in Triple Negative Breast Cancer
A Phase 2 study, sponsored by AEterna Zentaris.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT01698281: Clinical Trial Phase 2 study, sponsored by AEterna Zentaris.
NCT01698281 is a Phase 2 study that was terminated before completion, run by AEterna Zentaris. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01698281, a Phase 2 study, was terminated before completion, sponsored by AEterna Zentaris.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
This is a therapeutic exploratory Phase 2 study evaluating AEZS-108 compared to standard single agent cytotoxic chemotherapy (SSCC) as measured by the median time of progression-free survival (PFS) in patients with chemotherapy refractory triple negative (ER/PR/HER2-negative) LHRH-R positive metastatic breast cancer.
Primary Outcome
PFS is defined as the time elapsed from randomization to the date of documented progression or death, whichever comes first. For surviving patients without progression who begin alternative treatment, PFS will be censored at the last date of documented progression-free status prior to starting alternative treatment. Similarly, losses to follow up will be censored at the last date of documented progression-free status.
Interventions
- DRUG Dexamethasone
- DRUG AEZS-108
- DRUG SCCC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2012-12 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
Why NCT01698281 stopped before completion
NCT01698281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT01698281 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01698281 about?
NCT01698281 is a clinical study titled "Phase 2 Trial of AEZS-108 in Chemotherapy Refractory in Triple Negative Breast Cancer". This is a therapeutic exploratory Phase 2 study evaluating AEZS-108 compared to standard single agent cytotoxic chemotherapy (SSCC) as measured by the median time of progression-free survival (PFS) in patients with chemotherapy refractory triple negative (ER/PR/HER2-negative) LHRH-R positive metasta...
What is the current status of trial NCT01698281?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2012-12. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01698281?
The interventions under investigation include: Dexamethasone (DRUG), AEZS-108 (DRUG), SCCC (DRUG).
Who is sponsoring clinical trial NCT01698281?
This trial is sponsored by AEterna Zentaris, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01698281's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 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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