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

NCT04677855 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: PCUR101-003
• Study Type: interventional
• Target: 7
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Occurrence of Dose Limiting Toxicity

  Incidence of Adverse Adverse Events

  over the first 28 days of dosing

Secondary Outcomes (5)

• Determination of pharmacokinetic parameters - Tmax

  over the first 28 days of dosing

• Determination of pharmacokinetic parameters - Cmax

  over the first 28 days of dosing

• Determination of pharmacokinetic parameters - T1/2

  over the first 28 days of dosing

• Preliminary Evidence of efficacy/anti tumor activity - PSA levels

  through study completion, average of 12 months

• Preliminary Evidence of efficacy/anti tumor activity - RECIST

  through study completion, average of 12 months

Study Arms (4)

PCUR-101 Dose Escalation

EXPERIMENTAL

PCUR-101 dosed orally once per day in 28 day cycles. Patients will be enrolled into escalating dose levels during the dose escalation phase

Drug: PCUR-101

PCUR-101 Dose Expansion Cohort 1

EXPERIMENTAL

PCUR-101 dosed orally once per day in 28 day cycles

Drug: PCUR-101

PCUR-101 Dose Expansion Cohort 2

EXPERIMENTAL

PCUR-101 in combination with dutasteride dosed orally once per day in 28 day cycles

Drug: PCUR-101; Drug: Dutasteride 0.5 mg

PCUR-101 Dose Expansion Cohort 3

EXPERIMENTAL

PCUR-101 dosed orally once per day in combination with abiraterone (once per day) and prednisone (twice per day) in 28 day cycles

Drug: PCUR-101; Drug: Abiraterone and Prednisone

Interventions

PCUR-101 DRUG

50 mg capsules

PCUR-101 Dose Escalation; PCUR-101 Dose Expansion Cohort 1; PCUR-101 Dose Expansion Cohort 2; PCUR-101 Dose Expansion Cohort 3

Dutasteride 0.5 mg DRUG

0.5 mg capsules

PCUR-101 Dose Expansion Cohort 2

Abiraterone and Prednisone DRUG

500 mg tablets Abiraterone with 5 mg Prednisone Tablets

PCUR-101 Dose Expansion Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pellficure Pharmaceuticals, Inc: lead

Study Sites (4)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Nebraska Cancer Specialist

Omaha, Nebraska, 68130, United States

Location

St. George Private Hospital

Kogarah, New South Wales, 2217, Australia

Location

Southern Oncology Clinical Research

Bedford Park, South Australia, 5042, Australia

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dutasteride; abiraterone; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 dose escalation followed by a dose expansion

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 21, 2020
• Study Start: March 30, 2021
• Primary Completion: October 23, 2023
• Study Completion: November 20, 2023
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); AU (2)