Dose Escalation Study With MK-2206 in Patients With Locally Advanced or Metastatic Solid Tumors (MK-2206-002)

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

The primary purpose of this study is to investigate the Dose Limiting Toxicities (DLTs), pharmacokinetics (PK), and pharmacodynamics (PD) of MK-2206 administered orally to participants with advanced solid tumors. The preliminary efficacy of MK-2206 will also be investigated.

Inclusion Criteria:

• Participant 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 participant 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:

• Participant 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 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