Clinical Trials Logo
  1. Home
  2. Endometrial Cancer
  3. NCT04750941

Study of Copanlisib and Ketogenic Diet

Endometrial Cancer Clinical Trial

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

Clinical Trial 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 (R/R) follicular lymphoma (FL), (b) R/R endometrial cancer (EC) with a documented activating mutation in PIK3CA or loss of phosphatase and tensin homolog (PTEN).

Clinical Trial 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 11.2 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04750941
Study type Interventional
Source Columbia University
Contact
Status Active, not recruiting
Phase Phase 2
Start date February 10, 2022
Completion date December 2024
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05796518 - Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors N/A
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT06463028 - Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, Serabelisib With Paclitaxel, and Paclitaxel Alone in Patients With Advanced/Recurrent Endometrial Cancer Phase 2
Recruiting NCT06036836 - Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010) Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Completed NCT03820024 - MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback N/A
Active, not recruiting NCT05082025 - Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations Phase 2
Active, not recruiting NCT00587886 - Estrogen, Diet, Genetics and Endometrial Cancer
Completed NCT05378152 - Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity N/A
Suspended NCT05124743 - HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
Recruiting NCT03876860 - An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis N/A
Recruiting NCT04569773 - Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer
Completed NCT04534309 - Behavioral Weight Loss Program for Cancer Survivors in Maryland N/A
Not yet recruiting NCT06073184 - Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium Phase 2
Not yet recruiting NCT06366347 - ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab Phase 2
Not yet recruiting NCT05998798 - Revealing Engagement Patterns Among Endometrial Cancer Patients
Terminated NCT02907073 - Positron Emission Tomography (PET) Imaging Studies With NIS Reporter Phase 1/Phase 2
Completed NCT02549989 - Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer Phase 2