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NCT03745989 · ClinicalTrials.gov registry record · Phase 1
Study of MK-8353 + Selumetinib in Advanced/Metastatic Solid Tumors (MK-8353-014)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03745989: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT03745989 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03745989, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a multicenter, worldwide, open-label study of MK-8353 in combination with selumetinib in participants with histologically or cytologically confirmed diagnosis of advanced solid tumor. This study will evaluate the safety, tolerability, and exploratory efficacy of MK-8353 in combination with selumetinib.
Primary Outcome
A dose limiting toxicity (DLT) is defined as any hematologic or non-hematologic toxicity ≥Grade 3 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. The occurrence of any of the designated toxicities during Cycle 1 (3-week cycle) were considered a DLT, if assessed by the investigator to be possibly, probably, or definitely related to study treatment administration. The number of participants experiencing DLTs was assessed.
Interventions
- DRUG Selumetinib
- DRUG MK-8353
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-02-22 |
| Est. Completion | 2021-03-19 |
| Phase | Phase 1 |
What the finished NCT03745989 record still lists
NCT03745989 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Selumetinib is the first listed.
NCT03745989 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03745989 about?
NCT03745989 is a clinical study titled "Study of MK-8353 + Selumetinib in Advanced/Metastatic Solid Tumors (MK-8353-014)". This is a multicenter, worldwide, open-label study of MK-8353 in combination with selumetinib in participants with histologically or cytologically confirmed diagnosis of advanced solid tumor. This study will evaluate the safety, tolerability, and exploratory efficacy of MK-8353 in combination with s...
What is the current status of trial NCT03745989?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2019-02-22. Estimated completion is 2021-03-19.
What interventions are being tested in trial NCT03745989?
The interventions under investigation include: Selumetinib (DRUG), MK-8353 (DRUG).
Who is sponsoring clinical trial NCT03745989?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03745989's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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