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A Phase I Study of MK2206 in Patients With Locally Advanced or Metastatic Solid Tumors

Phase 1
20 Years
Not Enrolling
Solid Tumors

Thank you

Trial Information

A Phase I Study of MK2206 in Patients With Locally Advanced or Metastatic Solid Tumors

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Characterize safety and tolerability of MK2206 by monitoring incidence of protocol-defined dose limiting toxicities (DLTs)

Outcome Time Frame:

Day 1 - Day 28 (Cycle 1)

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

February 2010

Completion Date:

September 2011

Related Keywords:

  • Solid Tumors
  • locally advanced or metastatic solid tumors
  • Neoplasms