CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 63 enrolled
Drug / intervention
MK-2206 +1 moredrug
Likely dose
Not stated in 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/NCT01021748
NCT01021748Phase 1Completed

A Phase I Study of Oral MK-2206 in Combination With Oral AZD6244 in Patients With Locally Advanced or Metastatic Solid Tumors

Merck Sharp & Dohme LLC·interventional·Posted Nov 30, 2009·Updated Aug 7, 2018

In Brief

A Phase 1 clinical trial evaluating MK-2206 and AZD6244 for Locally Advanced or Metastatic Solid Tumors. Completed, enrolled 63 participants.

Detailed Summary

This study will investigate the safety and tolerability of combination therapy with MK-2206 and AZD6244 (selumetinib) and determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RPTD) for this drug combination in the treatment of participants with locally advanced or metastatic solid tumors. Preliminary efficacy data will also be collected. The primary hypotheses for this study are that: 1) the Dose-limiting Toxicities (DLTs) observed in participants with locally advanced or metastatic solid tumors after administration of combination therapy with MK-2206 and AZD6244 will be dose-dependent and allow for identification of the MTD, and 2) oral administration of combination therapy with MK-2206 and AZD6244 to participants with advanced solid tumors will be generally well-tolerated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
CollaboratorsAstraZeneca

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 30, 2009
Enrollment StartNov 23, 2009
Primary CompletionNov 26, 2012
Study CompletionJul 16, 2014
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 16.6 years ago

Interventions

MK-2206drug

Oral tablets

AZD6244drug

Oral capsules