Prostate Cancer Clinical Trial
Study of PCUR-101 in Combination With ADT in Patients With mCRPC
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.
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.
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
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 4 Locations for this study
Kogarah New South Wales, 2217, Australia
Liverpool New South Wales, 2170, Australia
Bedford Park South Australia, 5042, Australia
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.