Study of PCUR-101 in Combination With ADT in Patients With mCRPC
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT04677855
- Lead Sponsor
- Pellficure Pharmaceuticals, Inc
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 7
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description PCUR-101 Dose Expansion Cohort 3 Abiraterone and Prednisone PCUR-101 dosed orally once per day in combination with abiraterone (once per day) and prednisone (twice per day) in 28 day cycles PCUR-101 Dose Expansion Cohort 2 PCUR-101 PCUR-101 in combination with dutasteride dosed orally once per day in 28 day cycles PCUR-101 Dose Escalation PCUR-101 PCUR-101 dosed orally once per day in 28 day cycles. Patients will be enrolled into escalating dose levels during the dose escalation phase PCUR-101 Dose Expansion Cohort 2 Dutasteride 0.5 mg PCUR-101 in combination with dutasteride dosed orally once per day in 28 day cycles PCUR-101 Dose Expansion Cohort 1 PCUR-101 PCUR-101 dosed orally once per day in 28 day cycles PCUR-101 Dose Expansion Cohort 3 PCUR-101 PCUR-101 dosed orally once per day in combination with abiraterone (once per day) and prednisone (twice per day) in 28 day cycles
- Primary Outcome Measures
Name Time Method Occurrence of Dose Limiting Toxicity over the first 28 days of dosing Incidence of Adverse Adverse Events
- Secondary Outcome Measures
Name Time Method Determination of pharmacokinetic parameters - Cmax over the first 28 days of dosing peak concentrations of PCUR-101
Preliminary Evidence of efficacy/anti tumor activity - RECIST through study completion, average of 12 months as assessed by RECIST 1.1 criteria
Determination of pharmacokinetic parameters - Tmax over the first 28 days of dosing time to peak concentrations of PCUR-101
Determination of pharmacokinetic parameters - T1/2 over the first 28 days of dosing time from maximum concentration PCUR-101 to a reduction of plasma concentration by 50%
Preliminary Evidence of efficacy/anti tumor activity - PSA levels through study completion, average of 12 months as assessed by PSA changes
Trial Locations
- Locations (4)
Nebraska Cancer Specialist
🇺🇸Omaha, Nebraska, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
St. George Private Hospital
🇦🇺Kogarah, New South Wales, Australia
Southern Oncology Clinical Research
🇦🇺Bedford Park, South Australia, Australia