A Study of MK2206 in Locally Advanced or Metastatic Solid Tumors (2206-007)

Phase 1

Completed

• Conditions: Solid Tumors
• Interventions: Drug: MK2206 every other day; Drug: MK2206 once weekly

• Registration Number: NCT01071018
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study is designed to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MK2206 when administered with Every Other Day (QOD) and Once Weekly (QW) dosing schedules.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-17
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-18
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-04
• Last Update Posted: 2015-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Patient must have confirmed locally advanced or metastatic solid tumors that have failed to respond to standard therapy, have gotten worse or have come back after existing therapy
• Has adequate organ function
• Is ECOG Performance Scale 0-1
• Has a negative urine pregnancy test if patient is female
• Is able to swallow capsules and has no surgical or bodily condition that will prevent the patient from swallowing and absorbing oral medications on an ongoing basis

Exclusion Criteria

• Patient has had chemotherapy, radiotherapy, biological therapy or surgery within 4 weeks of starting the study and has not recovered from adverse events caused by the treatment
• Is currently participating or has participated in a study with an investigational compound or device within 28 days
• Has a primary central nervous system tumor
• Has a history or current evidence of heart disease, slow heart rate or untreated high blood pressure
• Is a known diabetic who is taking insulin or oral antidiabetic therapy
• Is pregnant or breastfeeding or planning to become pregnant during the study
• Is positive HIV antibody, HBs antigen or HCV antibody

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
QOD Schedule	MK2206 every other day	QOD Schedule, MK2206 every other day
QW Schedule	MK2206 once weekly	QW Schedule, MK2206 once weekly

Primary Outcome Measures

Name	Time	Method
Characterize safety and tolerability of MK2206 by monitoring incidence of protocol-defined dose limiting toxicities (DLTs)	Day 1 - Day 28 (Cycle 1)

Secondary Outcome Measures

Name	Time	Method
Assess pharmacokinetic (PK) profile of MK2206 by determining parameters: AUC, Cmax, and Tmax	Day 1 - Day 28 (Cycle 1)