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NCT01360840 · ClinicalTrials.gov registry record · Phase 2
EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer
A Phase 2 study, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
NCT01360840: Completed Phase 2 study, sponsored by EMD Serono.
NCT01360840 is a Phase 2 study that has completed, run by EMD Serono. The registered enrollment target is 180 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01360840, a Phase 2 study, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
Study Summary
The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD 525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).
Primary Outcome
PFS was defined as time from randomization until the first documented sign of objective radiographic disease progression (ORDP) or death from any cause. Death was considered as an event only if it was reported within 12 weeks after last tumor assessment without progression. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy. Assessment was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) mo
Interventions
- OTHER Placebo
- OTHER Standard of Care (SoC)
- DRUG EMD 525797
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT01360840 record still lists
NCT01360840 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01360840 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01360840 about?
NCT01360840 is a clinical study titled "EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer". The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD 525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cance...
What is the current status of trial NCT01360840?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2011-04. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01360840?
The interventions under investigation include: Placebo (OTHER), Standard of Care (SoC) (OTHER), EMD 525797 (DRUG).
Who is sponsoring clinical trial NCT01360840?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01360840's enrollment target sits among peer trials
180 365th of 2000 higher than 1,610 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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