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

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pellficure Pharmaceuticals, Inc
• Treatments: Dutasteride; Prednisone

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