Status:
TERMINATED
A Study of MK-2206 in Combination With Trastuzumab and Lapatinib for the Treatment of HER2+ Solid Tumors (MK-2206-015)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Advanced Solid Tumors
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will assess the safety, tolerability, and the maximum tolerated dose (MTD) of MK-2206 in combination with both trastuzumab and trastuzumab/lapatinib in participants with human epidermal gro...
Detailed Description
This study was divided into 2 parts. In Part 1, cohorts of 3 participants were to be enrolled sequentially on escalating doses of MK-2206 in combination with a fixed dose of trastuzumab. Barring dose-...
Eligibility Criteria
Inclusion
- Have a histologically or cytologically-confirmed locally advanced or metastatic HER2+ solid tumor.
- Have performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Have adequate organ function.
- Female participants have a negative pregnancy test 72 hours prior to receiving the first dose of study medication.
- Have completed any major surgery for a minimum of 28 days prior to enrollment in this study.
- Able to swallow tablets and has no surgical or anatomical condition that will preclude the patient from swallowing or absorbing oral medications on an ongoing basis.
Exclusion
- Had chemotherapy, radiotherapy or biological therapy within 4 weeks of screening. Participants receiving trastuzumab and/or lapatinib prior to screening must be off both medications for 1 week prior to first dose of MK-2206 if trastuzumab had been administered at 2 mg/kg weekly and 3 weeks if trastuzumab had been administered at 6 mg/kg weekly.
- Currently participating or has participated in a study with an investigational compound or device within 30 days, or 5x half-life from prior agents, whichever is longer, of Day 1 of this study
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has a primary CNS tumor.
- Has known hypersensitivity to the components of study drugs or its analogs.
- Has a history or evidence of heart disease.
- Has uncontrolled hypertension or diabetes.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or is expecting to conceive or father children during the study.
- Is HIV positive.
- Has symptomatic ascites or pleural effusion.
- Is receiving treatment with oral corticosteroids for reason other than CNS metastasis.
Key Trial Info
Start Date :
September 15 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00963547
Start Date
September 15 2009
End Date
December 22 2011
Last Update
June 4 2024
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