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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
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
Occurrence of Dose Limiting Toxicity
Incidence of Adverse Adverse Events
Time frame: over the first 28 days of dosing
Determination of pharmacokinetic parameters - Tmax
time to peak concentrations of PCUR-101
Time frame: over the first 28 days of dosing
Determination of pharmacokinetic parameters - Cmax
peak concentrations of PCUR-101
Time frame: over the first 28 days of dosing
Determination of pharmacokinetic parameters - T1/2
time from maximum concentration PCUR-101 to a reduction of plasma concentration by 50%
Time frame: over the first 28 days of dosing
Preliminary Evidence of efficacy/anti tumor activity - PSA levels
as assessed by PSA changes
Time frame: through study completion, average of 12 months
Preliminary Evidence of efficacy/anti tumor activity - RECIST
as assessed by RECIST 1.1 criteria
Time frame: through study completion, average of 12 months
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