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NCT01578655 · ClinicalTrials.gov registry record · Phase 3
Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer
A Phase 3 study, sponsored by Achieve Life Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 630
- Enrollment target
NCT01578655: Completed Phase 3 study, sponsored by Achieve Life Sciences.
NCT01578655 is a Phase 3 study that has completed, run by Achieve Life Sciences. The registered enrollment target is 630 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01578655, a Phase 3 study, has completed, sponsored by Achieve Life Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 630 participants
- Enrollment target
Study Summary
This Phase 3 study has been designed to confirm that adding custirsen to cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter, international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs. cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal probability to the two arms.
Primary Outcome
To determine whether the survival for patients randomized to the investigational arm (cabazitaxel/prednisone plus custirsen) is consistent with longer survival as compared to patients randomized to the control arm (cabazitaxel/prednisone).
Interventions
- DRUG prednisone
- DRUG custirsen sodium
- DRUG cabazitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 630 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-07 |
| Phase | Phase 3 |
What the finished NCT01578655 record still lists
NCT01578655 is an interventional study that assigns participants to a tested intervention. The registered 630 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 3 interventions - of which prednisone is the first listed.
NCT01578655 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01578655 about?
NCT01578655 is a clinical study titled "Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer". This Phase 3 study has been designed to confirm that adding custirsen to cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). This will be a ra...
What is the current status of trial NCT01578655?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 630 participants. The study started on 2012-08. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01578655?
The interventions under investigation include: prednisone (DRUG), custirsen sodium (DRUG), cabazitaxel (DRUG).
Who is sponsoring clinical trial NCT01578655?
This trial is sponsored by Achieve Life Sciences, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01578655's enrollment target sits among peer trials
630 581st of 2000 higher than 1,417 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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