Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04750941
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-08
First Post:
2021-02-08
Brief Title:
Study of Copanlisib and Ketogenic Diet
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Pilot Phase II Study of the PI3K Inhibitor Copanlisib in Combination With a Ketogenic Diet in the Treatment of Patients With Relapsed or Refractory Follicular Lymphoma or Endometrial Cancer
Status:
ACTIVE_NOT_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 is a multicenter open label pilot phase II study of the PI3K inhibitor copanlisib in combination with a ketogenic diet in the treatment of patients with one of the following malignancies a relapsed or refractory RR follicular lymphoma FL b RR endometrial cancer EC with a documented activating mutation in PIK3CA or loss of phosphatase and tensin homolog PTEN
Detailed Description:
As the investigators recently reported ketogenic diet can suppress hyperinsulinemia associated with PI3K inhibitors leading to potentiation of the anti-tumor effects of PI3K inhibitors Copanlisib potently inhibits PI3Kα and PI3Kδ It has been approved for the treatment of relapsed follicular lymphoma based on ORR of 59 84 of 142 patients The CR rate in FL was 14 and the median progression-free survival was 112 months Copanlisib demonstrated encouraging clinical activity in marginal zone lymphoma ORR 70 including 9 CR While these results are clinically meaningful FL and MZL inevitably develop resistance to copanlisib with time even in those patients who initially respond to the therapy Novel strategies to improve the efficacy of copanlisib in FL and MZL by improving CR and PFS may transform how to manage these incurable malignancies
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?:
False
Is an FDA AA801 Violation?:
None