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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04677855
• Other study ID #: PCUR101-003
• Status: Terminated
• Phase: Phase 1
• Start date: March 30, 2021
• Est. completion date: November 20, 2023

Study information

• Verified date: April 2024
• Source: Pellficure Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: November 20, 2023
• Est. primary completion date: October 23, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed diagnosis of prostate cancer

• Demonstrates metastatic CRPC

• Castrate level of serum testosterone at screening

• Adequate hematologic, renal, and hepatic function

• ECOG status =1

• Life expectancy of at least 3 months

• No more than one prior course of cytotoxic chemotherapy

Exclusion Criteria:

• Pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology

• Visceral metastasis excluding lymph nodes

• Use of opiate analgesics for prostate cancer pain or non-cancer pain

• other investigational agents or concurrent anticancer therapy other than standard androgen deprivation therapy within 4 weeks

• History of bleeding disorder

• History of seizure disorder

• Concomitant use of warfarin

• Prior exposure to PCUR-101

• History of myocardial infarction, arterial thrombotic events, heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia

• Received wide-field external beam radiation therapy within 4 weeks

• Moderate to severe neuropathy

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• PCUR-101
50 mg capsules
• Dutasteride 0.5 mg
0.5 mg capsules
• Abiraterone and Prednisone
500 mg tablets Abiraterone with 5 mg Prednisone Tablets

Locations

Country	Name	City	State
Australia	Southern Oncology Clinical Research	Bedford Park	South Australia
Australia	St. George Private Hospital	Kogarah	New South Wales
United States	University of Michigan	Ann Arbor	Michigan
United States	Nebraska Cancer Specialist	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Pellficure Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Dose Limiting Toxicity	Incidence of Adverse Adverse Events	over the first 28 days of dosing
Secondary	Determination of pharmacokinetic parameters - Tmax	time to peak concentrations of PCUR-101	over the first 28 days of dosing
Secondary	Determination of pharmacokinetic parameters - Cmax	peak concentrations of PCUR-101	over the first 28 days of dosing
Secondary	Determination of pharmacokinetic parameters - T1/2	time from maximum concentration PCUR-101 to a reduction of plasma concentration by 50%	over the first 28 days of dosing
Secondary	Preliminary Evidence of efficacy/anti tumor activity - PSA levels	as assessed by PSA changes	through study completion, average of 12 months
Secondary	Preliminary Evidence of efficacy/anti tumor activity - RECIST	as assessed by RECIST 1.1 criteria	through study completion, average of 12 months