Trials / Completed
CompletedNCT03745989
Study of MK-8353 + Selumetinib in Advanced/Metastatic Solid Tumors (MK-8353-014)
Phase 1b Open-label Study of MK-8353 in Combination With Selumetinib (MK-5618) in Participants With Advanced/Metastatic Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
As specified by Phase 1 protocol-flexible language, modifications to the dose or dosing regimen can be made to achieve the scientific goals of the trial objectives and/or ensure appropriate safety of the trial participants. The proposed doses may be adjusted based on evaluation of safety, tolerability, and pharmacokinetic data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MK-8353 | Participants will receive MK-8353 orally twice daily (BID), escalated sequentially from 50 mg to 250 mg. |
| DRUG | Selumetinib | Participants will receive selumetinib orally BID, escalated sequentially from 25 mg to 75 mg. |
Timeline
- Start date
- 2019-02-22
- Primary completion
- 2021-03-19
- Completion
- 2021-03-19
- First posted
- 2018-11-19
- Last updated
- 2023-07-27
- Results posted
- 2023-01-25
Locations
5 sites across 3 countries: United States, Canada, Switzerland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03745989. Inclusion in this directory is not an endorsement.