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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: MK2206 every other day; Drug: MK2206 once weekly

Study type: Interventional

Funder types: Industry

Identifiers

NCT01071018

2010_509

2206-007

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

QOD Schedule

Experimental group

Description:

QOD Schedule, MK2206 every other day

Treatment:

Drug: MK2206 every other day

QW Schedule

Experimental group

Description:

QW Schedule, MK2206 once weekly

Treatment:

Drug: MK2206 once weekly