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

• Status: Completed
• Trial end date: 2011-07-11
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

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