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A Phase I Investigation of the Combination of MK2206, Trastuzumab and Lapatinib in HER2+ Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors, Breast Cancer

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Trial Information

A Phase I Investigation of the Combination of MK2206, Trastuzumab and Lapatinib in HER2+ Solid Tumors


Inclusion Criteria:



- Patient has a histologically or cytologically-confirmed locally advanced or
metastatic HER2+ solid tumor

- Female patients have a negative pregnancy test

- Patient is able to swallow tablets

Exclusion Criteria:

- Patient has had chemotherapy, radiotherapy or biological therapy within 4 weeks of
screening. Patients who were receiving trastuzumab and/or lapatinib prior to
screening must be off both medications for 1 week prior to first dose of MK2206 if
trastuzumab had been administered at 2 mg/kg weekly and 3 weeks if trastuzumab had
been administered at 6 mg/kg weekly

- Patient has primary CNS tumor or known active CNS metastases

- Patient has a history or evidence of heart disease

- Patient has poorly controlled high blood pressure or diabetes

- Patient is pregnant or breastfeeding or is expecting to conceive or father children
during the study

- Patient is HIV positive

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Dose-Limiting Toxicities (DLTs) and Maximum tolerated dose (MTD) of MK2206 in combination with Trastuzumab and Trastuzumab/Lapatinib

Outcome Time Frame:

21 Days

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

2009_646

NCT ID:

NCT00963547

Start Date:

September 2009

Completion Date:

December 2011

Related Keywords:

  • Advanced Solid Tumors
  • Breast Cancer
  • Documented to be HER2+
  • Breast Neoplasms
  • Neoplasms

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