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NCT02278250 · ClinicalTrials.gov registry record · Phase 1
First in Human Study of M4344 in Participants With Advanced Solid Tumors
A Phase 1 study, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 97
- Enrollment target
NCT02278250: Completed Phase 1 study, sponsored by EMD Serono Research & Development Institute.
NCT02278250 is a Phase 1 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 97 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02278250, a Phase 1 study, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 97 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the safety and tolerability of multiple ascending doses of single-agent M4344 administered twice-weekly (BIW), twice daily (BID) or once daily dose schedule in participants with advanced solid tumors. This investigation is a three part study examining M4344 alone and in combination with carboplatin to determine the safety and maximum tolerated dose.
Primary Outcome
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, regardless if it is considered related to the medicinal product. Serious AE: AE that resulted in any of the following outcomes: death; life threatening; p
Interventions
- DRUG M4344 10 mg BIW
- DRUG M4344 20 mg BIW
- DRUG M4344 40 mg BIW
- DRUG M4344 80 mg BIW
- DRUG M4344 160 mg BIW
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2015-01-26 |
| Est. Completion | 2021-09-24 |
| Phase | Phase 1 |
What the finished NCT02278250 record still lists
NCT02278250 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% higher).
The record links to 0 conditions, and to 5 interventions - of which M4344 10 mg BIW is the first listed.
NCT02278250 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02278250 about?
NCT02278250 is a clinical study titled "First in Human Study of M4344 in Participants With Advanced Solid Tumors". The purpose of this study was to evaluate the safety and tolerability of multiple ascending doses of single-agent M4344 administered twice-weekly (BIW), twice daily (BID) or once daily dose schedule in participants with advanced solid tumors. This investigation is a three part study examining M4344 ...
What is the current status of trial NCT02278250?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 97 participants. The study started on 2015-01-26. Estimated completion is 2021-09-24.
What interventions are being tested in trial NCT02278250?
The interventions under investigation include: M4344 10 mg BIW (DRUG), M4344 20 mg BIW (DRUG), M4344 40 mg BIW (DRUG), M4344 80 mg BIW (DRUG), M4344 160 mg BIW (DRUG).
Who is sponsoring clinical trial NCT02278250?
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 NCT02278250's enrollment target sits among peer trials
97 597th of 2000 higher than 1,401 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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