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

Stopped early · Phase 1

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT04677855

Run by

Pellficure Pharmaceuticals, Inc

People needed

7

Starts

2021-03-30

Expected to finish

2023-11-20

Last updated by the study team

2024-04-10

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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