Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT01501604
Status:
WITHDRAWN
Last Update Posted:
2015-09-17
First Post:
2011-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BKM120 in Cancers With PIK3CA Activating Mutations
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
An Open Label, Phase II Trial of BKM120 in Cancers With PIK3CA Activating Mutations
Status:
WITHDRAWN
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study has been closed due to lack of accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: