A Study of MK-2206 in Combination With Trastuzumab and Lapatinib for the Treatment of HER2+ Solid Tumors (MK-2206-015)

• Status: Terminated
• Trial end date: 2011-12-22
• Target enrollment: 0
• Participant gender: All

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 growth factor receptor 2 positive (HER2+) breast cancer and other solid tumors. The primary hypothesis of this study is that the combination of oral MK-2206 with trastuzumab or with trastuzumab/lapatinib will be well tolerated in participants with advanced HER2+ solid tumors.

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Lapatinib; Trastuzumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.