CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
MK-8353 +1 moredrug
Likely dose
MK-8353 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03745989
NCT03745989Phase 1Completed

Phase 1b Open-label Study of MK-8353 in Combination With Selumetinib (MK-5618) in Participants With Advanced/Metastatic Solid Tumors

Merck Sharp & Dohme LLC·interventional·Posted Nov 19, 2018·Updated Jul 27, 2023

In Brief

A Phase 1 clinical trial evaluating MK-8353 and Selumetinib for Solid Tumors. Completed, enrolled 30 participants across 5 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors
CountriesCanada, Switzerland, United States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedNov 19, 2018
Enrollment StartFeb 22, 2019
Primary CompletionMar 19, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.6 years ago

Interventions

MK-8353drug

Participants will receive MK-8353 orally twice daily (BID), escalated sequentially from 50 mg to 250 mg.

Selumetinibdrug

Participants will receive selumetinib orally BID, escalated sequentially from 25 mg to 75 mg.