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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.

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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

FieldValue
Enrollment Target 101 participants
Start Date 2013-12-13
Est. Completion 2018-08-09
Phase Phase 1

Sponsor

EMD Serono

71 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.