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

Phase 1
18 Years
Not Enrolling
Locally Advanced Tumors, Metastatic Solid Tumors, Cancer, Neoplasms

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Trial Information

A Phase I Dose Escalation Study of Oral 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 normal organ function; is no greater than 2 on the ECOG Performance Scale

- Has a negative blood or urine pregnancy test within 72 hours of receiving the first
dose of study drug 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 30 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 HIV-positive

- Has known history of Hepatitis B or C or active Hepatitis A

- Is receiving treatment with oral corticosteroids

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 rate of adverse experiences

Outcome Time Frame:

study duration

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

July 2011

Related Keywords:

  • Locally Advanced Tumors
  • Metastatic Solid Tumors
  • Cancer
  • Neoplasms
  • Neoplasms