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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 is a Phase 1 study that has completed, run by EMD Serono. The registered enrollment target is 101 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01971515
The ClinicalTrials.gov registry entry for NCT01971515 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which MSC2363318A is the first listed.
NCT01971515 reports 0 study locations.
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.
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