Ignite Creation Date:
2024-05-06 @ 7:24 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02523014
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2015-08-11
Brief Title:
Vismodegib FAK Inhibitor GSK2256098 Capivasertib and Abemaciclib in Treating Patients with Progressive Meningiomas
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial of SMO AKT NF2CDK Inhibitors in Progressive Meningiomas with SMO AKT NF2CDK Pathway Mutations
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well vismodegib focal adhesion kinase FAK inhibitor GSK2256098 and capivasertib work in treating patients with meningioma that is growing spreading or getting worse progressive Vismodegib FAK inhibitor GSK2256098 capivasertib and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the activity of a SMO inhibitor in patients with meningiomas harboring SMO and PTCH1 mutations as measured by 6-month progression free survival PFS and response rate
II To determine the activity of a FAK inhibitor in patients with meningiomas harboring NF2 mutations as measured by 6-month PFS and response rate
III To determine the activity of an AKT inhibitor in patients with meningiomas harboring AKT1PIK3CAPTEN mutations as measured by 6-month PFS and response rate
IV To determine the activity of a CDK inhibitor in patients with meningiomas harboring alterations in the CDK pathway or NF2 alterations as measured by 6-month PFS and response rate
SECONDARY OBJECTIVES
I To determine overall survival and progression-free survival of SMO FAK AKT and CDK inhibitors in patients with meningioma
II To determine adverse event rates of SMO FAK AKT and CDK inhibitors in patients with meningioma
III To determine the activity of SMO FAK AKT and CDK inhibitors as measured by response rate by central radiology review
OUTLINE Patients are assigned to 1 of 4 treatment arms based on their mutation status
ARM A SMOPTCH1 mutation Patients receive vismodegib orally PO once daily QD Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity CLOSED TO ACCRUAL FEBRUARY 2018
ARM B NF2 mutation Patients receive FAK inhibitor GSK2256098 PO twice daily BID Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity CLOSED TO ACCRUAL JULY 2017
ARM C AKT1 PIK3CA or PTEN mutation Patients receive capivasertib PO BID on days 1-4 Treatment repeats every 7 days for up to 1 cycle 28 days in the absence of disease progression or unacceptable toxicity
ARM D CDK4 CDK6 CDKN2A CCND1 CCND2 CCND3 CCNE1 alterations Patients receive abemaciclib PO every 12 hours Q12H Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6 months for a maximum of 5 years from registration
I To determine the activity of a SMO inhibitor in patients with meningiomas harboring SMO and PTCH1 mutations as measured by 6-month progression free survival PFS and response rate
II To determine the activity of a FAK inhibitor in patients with meningiomas harboring NF2 mutations as measured by 6-month PFS and response rate
III To determine the activity of an AKT inhibitor in patients with meningiomas harboring AKT1PIK3CAPTEN mutations as measured by 6-month PFS and response rate
IV To determine the activity of a CDK inhibitor in patients with meningiomas harboring alterations in the CDK pathway or NF2 alterations as measured by 6-month PFS and response rate
SECONDARY OBJECTIVES
I To determine overall survival and progression-free survival of SMO FAK AKT and CDK inhibitors in patients with meningioma
II To determine adverse event rates of SMO FAK AKT and CDK inhibitors in patients with meningioma
III To determine the activity of SMO FAK AKT and CDK inhibitors as measured by response rate by central radiology review
OUTLINE Patients are assigned to 1 of 4 treatment arms based on their mutation status
ARM A SMOPTCH1 mutation Patients receive vismodegib orally PO once daily QD Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity CLOSED TO ACCRUAL FEBRUARY 2018
ARM B NF2 mutation Patients receive FAK inhibitor GSK2256098 PO twice daily BID Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity CLOSED TO ACCRUAL JULY 2017
ARM C AKT1 PIK3CA or PTEN mutation Patients receive capivasertib PO BID on days 1-4 Treatment repeats every 7 days for up to 1 cycle 28 days in the absence of disease progression or unacceptable toxicity
ARM D CDK4 CDK6 CDKN2A CCND1 CCND2 CCND3 CCNE1 alterations Patients receive abemaciclib PO every 12 hours Q12H Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6 months for a maximum of 5 years from registration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2015-00546 | REGISTRY | NCI Clinical Trials Reporting Program | None |