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

NCT ID: NCT04677855

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-30
• Study Completion Date: 2023-11-20

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PCUR-101 Dose Escalation

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

Group Type: EXPERIMENTAL

PCUR-101

Intervention Type: DRUG

50 mg capsules

PCUR-101 Dose Expansion Cohort 1

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

Group Type: EXPERIMENTAL

PCUR-101

Intervention Type: DRUG

50 mg capsules

PCUR-101 Dose Expansion Cohort 2

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

Group Type: EXPERIMENTAL

PCUR-101

Intervention Type: DRUG

50 mg capsules

Dutasteride 0.5 mg

Intervention Type: DRUG

0.5 mg capsules

PCUR-101 Dose Expansion Cohort 3

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

Group Type: EXPERIMENTAL

PCUR-101

Intervention Type: DRUG

50 mg capsules

Abiraterone and Prednisone

Intervention Type: DRUG

500 mg tablets Abiraterone with 5 mg Prednisone Tablets

Interventions

PCUR-101

50 mg capsules

Intervention Type: DRUG

Dutasteride 0.5 mg

0.5 mg capsules

Intervention Type: DRUG

Abiraterone and Prednisone

500 mg tablets Abiraterone with 5 mg Prednisone Tablets

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Pellficure Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Michigan

Ann Arbor, Michigan, United States

Nebraska Cancer Specialist

Omaha, Nebraska, United States

St. George Private Hospital

Kogarah, New South Wales, Australia

Southern Oncology Clinical Research

Bedford Park, South Australia, Australia

Countries

United States; Australia

Other Identifiers

PCUR101-003

Identifier Type: -

Identifier Source: org_study_id