An Open Label, Phase II Trial of BKM120 in Cancers With PIK3CA Activating Mutations
Subjects enrolled in this study will receive BKM120 once daily, orally, in cycles of 28
days.
During Cycles 1 and 2, the following tests and procedures will be done on days 1 and 15:
- physical exam
- performance status
- blood tests
- pregnancy test (if applicable)
- neuropsychiatric assessments
Starting at Cycle 2 and then every other cycle thereafter (approximately every 8 weeks)
tumor assessment will be performed by CT/MRI or PET scan. A chest x-ray will also be
performed every 8 weeks.
Beginning with Cycle 3, the following tests/procedures will be performed on Day 1 of each
cycle:
- physical exam
- performance status
- blood tests
- neuropsychiatric assessments
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate
Objective Response Rate (CR or PR) by RECIST 1.1 criteria
2 years
No
Jeffrey A Engelman, MD, PhD
Principal Investigator
Massachusetts General Hospital
United States: Food and Drug Administration
11-211
NCT01501604
January 2012
December 2015
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