NCT06218667

A Study of Copanlisib in Combination with Degarelix in People with Prostate Cancer

CHARIOT: a Phase 1b/2 Study of Androgen Deprivation Therapy and Copanlisib in High-Risk Localized Prostate Cancer Patients Prior to Radical Prostatectomy

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The researchers are doing this study to find out whether copanlisib in combination with degarelix, given before standard surgical treatment (radical prostatectomy), is a safe and effective treatment that causes few or mild side effects for people who have localized high-risk prostate cancer.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Copanlisib	Dose level 1 (starting dose): 45 mg of copanlisib IV weekly x 3 weeks on/1 week off Dose level 2 (standard dose): 60 mg of copanlisib IV weekly x 3 weeks on/1 week off
DRUG	Degarelix	Degarelix (GnRH antagonist): 240 mg loading dose sub-cutaneous once on C1D1; 80 mg maintenance dose on C2D1 and C3D1.
PROCEDURE	Radical Prostatectomy	Standard treatment

Timeline

• Start date: 2024-01-11
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2024-01-23
• Last updated: 2024-10-31

Regulatory

• FDA-regulated drug study