Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT01501604
Brief Summary:
In people whos cancers have a PIK3CA mutation, this trial will be evaluating the drug BKM120 as a possible treatment. BKM120 works by blocking the phosphatidylinositol-3-kinase (PI3K)pathway, thereby inhibiting tumor growth and survival.
The purpose of this study is to learn if the study drug BKM120 can shrink or slow the growth of your tumor. The safety of BKM120 will also be studied. Your physical state, symptoms, change in the size of your tumor, and laboratory findings obtained while you are on study will help the research team decide if BKM120 is safe and effective in patients with advanced cancers.
Detailed Description:
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
Study:
NCT01501604
Study Brief:
Protocol Section:
NCT01501604