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NCT01971515 · ClinicalTrials.gov registry record · Phase 1
First-in-Human Dose Escalation Trial in Subjects With Advanced Malignancies
A Phase 1 study, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 1
- Development phase
- 101
- Enrollment target
NCT01971515: Completed Phase 1 study, sponsored by EMD Serono.
NCT01971515 is a Phase 1 study that has completed, run by EMD Serono. The registered enrollment target is 101 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01971515, a Phase 1 study, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 101 participants
- Enrollment target
Study Summary
This is a Phase 1, first-in-human, open-label, non-randomized, dose escalation, trial to explore the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and clinical activity signals of MSC2363318A.
Interventions
- DRUG MSC2363318A
- DRUG MSC2363318A plus Trastuzumab
- DRUG MSC2363318A plus Tamoxifen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2013-12-13 |
| Est. Completion | 2018-08-09 |
| Phase | Phase 1 |
What the finished NCT01971515 record still lists
NCT01971515 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% higher).
The record links to 0 conditions, and to 3 interventions - of which MSC2363318A is the first listed.
NCT01971515 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01971515 about?
NCT01971515 is a clinical study titled "First-in-Human Dose Escalation Trial in Subjects With Advanced Malignancies". This is a Phase 1, first-in-human, open-label, non-randomized, dose escalation, trial to explore the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and clinical activity signals of MSC2363318A.
What is the current status of trial NCT01971515?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 101 participants. The study started on 2013-12-13. Estimated completion is 2018-08-09.
What interventions are being tested in trial NCT01971515?
The interventions under investigation include: MSC2363318A (DRUG), MSC2363318A plus Trastuzumab (DRUG), MSC2363318A plus Tamoxifen (DRUG).
Who is sponsoring clinical trial NCT01971515?
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 NCT01971515's enrollment target sits among peer trials
101 546th of 2000 higher than 1,455 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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