NCT04677855

Study of PCUR-101 in Combination With ADT in Patients With mCRPC

A Phase I Study of PCUR-101 in Combination With Androgen Directed Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Pellficure Pharmaceuticals, Inc · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, non-randomized, Phase I, dose escalation/dose expansion study in cohorts of patients with metastatic CRPC at Screening. Dose escalation uses a 3+3 design to determine the maximum tolerated dose (MTD). Once the MTD is defined, the dose expansion phase is used to define the recommended phase 2 dose.

Detailed description

Dose Escalation Phase: Eligible patients will enter the study and start receiving daily doses of PCUR-101 during Cycle 1. Subsequent dose cohorts will receive the next higher dose of PCUR-101 according to a 3 + 3 design until the MTD is determined. Patients may remain on these treatment cycles if they do not progress or experience any dose limiting toxicities (DLTs). Dose Expansion Phase: Once the MTD has been determined, approximately 18 patients in 3 cohorts will be enrolled for further evaluations of safety, PK, and preliminary clinical activity during successive 28-day cycles in the dose expansion phase: Expansion Cohort 1 will receive PCUR-101 at the MTD, Expansion Cohort 2 will receive PCUR-101 at one dose level lower than the MTD and dutasteride once daily, and Expansion Cohort 3 (6 patients) will receive PCUR-101 at one dose level lower than the MTD in patients about to start abiraterone (1000 mg QD) and prednisone (5 mg twice daily \[BID\]) as their standard of care.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	PCUR-101	50 mg capsules
DRUG	Dutasteride 0.5 mg	0.5 mg capsules
DRUG	Abiraterone and Prednisone	500 mg tablets Abiraterone with 5 mg Prednisone Tablets

Timeline

• Start date: 2021-03-30
• Primary completion: 2023-10-23
• Completion: 2023-11-20
• First posted: 2020-12-21
• Last updated: 2024-04-10

Locations

4 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study