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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 is a Phase 1 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 97 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02278250
The ClinicalTrials.gov registry entry for NCT02278250 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which M4344 10 mg BIW is the first listed.
NCT02278250 reports 0 study locations.
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.
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