Status:
COMPLETED
Dose Escalation Study With MK-2206 in Patients With Locally Advanced or Metastatic Solid Tumors (MK-2206-002)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Locally Advanced Tumors
Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2011
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00670488
Start Date
April 15 2008
End Date
July 11 2011
Last Update
April 1 2019
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