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NCT03138538 · ClinicalTrials.gov registry record · Phase 1
M8891 First in Human in Solid Tumors
A Phase 1 study, sponsored by EMD Serono Research & Development Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT03138538: Clinical Trial Phase 1 study, sponsored by EMD Serono Research & Development Institute.
NCT03138538 is a Phase 1 study that was terminated before completion, run by EMD Serono Research & Development Institute. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03138538, a Phase 1 study, was terminated before completion, sponsored by EMD Serono Research & Development Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
The purpose of this study was to determine the maximum tolerated dose (MTD), safety, tolerability, Pharmacokinetic (PK), pharmacodynamic and clinical activity of M8891 as single agent in participants with advanced solid tumors in Part 1.
Primary Outcome
A DLT was defined as the occurrence of any of following events that were judged by the study investigator, to be related to the study medication: Grade 4 liver enzyme elevation; Grade 4 neutropenia lasting \>5 days or Grade \>= 3 neutropenia with fever; Grade 4 thrombocytopenia lasting \>5 days or Grade \>=3 thrombocytopenia with clinically significant bleeding; Any treatment interruption \>7 days or \>30% of total dose in Cycle 1 due to AEs not related to the underlying disease or concomitant m
Interventions
- DRUG Part 1: M8891
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2017-08-08 |
| Est. Completion | 2020-09-16 |
| Phase | Phase 1 |
Why NCT03138538 stopped before completion
NCT03138538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which Part 1: M8891 is the first listed.
NCT03138538 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03138538 about?
NCT03138538 is a clinical study titled "M8891 First in Human in Solid Tumors". The purpose of this study was to determine the maximum tolerated dose (MTD), safety, tolerability, Pharmacokinetic (PK), pharmacodynamic and clinical activity of M8891 as single agent in participants with advanced solid tumors in Part 1.
What is the current status of trial NCT03138538?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2017-08-08. Estimated completion is 2020-09-16.
What interventions are being tested in trial NCT03138538?
The interventions under investigation include: Part 1: M8891 (DRUG).
Who is sponsoring clinical trial NCT03138538?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03138538's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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