A Phase I Study of PCUR-101 in Combination With Androgen Suppression Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
Phase 1
Terminated
- Conditions
- Metastatic Castration-Resistant Prostate Cancer
- Interventions
- Drug: PCUR - 101
- Registration Number
- NCT03137758
- Lead Sponsor
- Pellficure Pharmaceuticals, Inc
- Brief Summary
This is an open label, non-randomized, Phase I, dose escalation/dose expansion study of PCUR-101 in combination with androgen suppression therapy in the patients with metastatic CRPC
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 12
Inclusion Criteria
- histologically confirmed diagnosis of metastatic CRPC
- standard of care androgen deprivation treatment
- castrate serum level of testosterone of ≤ 50 ng/dL (≤ 1.73 mmol/L)
- progressive disease while receiving androgen deprivation therapy
- previously treated with abiraterone, enzalutamide alone or in combination AND must have demonstrated evidence of objective progression as per PCWG3 criteria
- adequate hematologic, renal and hepatic function
- KPS of ≥ 70 or ECOG of 0 to 1
Exclusion Criteria
- pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology
- use of opiate analgesics for prostate cancer pain within 4 week of treatment start
- more than one sequential second generation AR-directed therapy
- received cytotoxic chemotherapy for either metastatic HSPC or CRPC within the last 12 weeks or other investigational agents within 4 weeks
- history of bleeding disorder
- history of seizure disorder
- concomitant use of therapeutic anticoagulation
- history of or current cardiac issues
- received external beam radiation therapy within 4 weeks
- CTCAE Grade > 2 neuropathy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Level 6 (300 mg) PCUR-101 PCUR - 101 - Level 1 (50 mg) PCUR-101 PCUR - 101 Starting Dose, 3+3 Cohort Design Level 5 (250 mg) PCUR-101 PCUR - 101 - Level 4 (200 mg) PCUR-101 PCUR - 101 - Level 3 (150 mg) PCUR-101 PCUR - 101 - Level 2 (100 mg) PCUR-101 PCUR - 101 -
- Primary Outcome Measures
Name Time Method Toxicities and Adverse Events 28 days determined by type and severity using the most recent version of the CTCAE criteria
- Secondary Outcome Measures
Name Time Method Toxicities and adverse events up to 2 years determined by type and severity using the most recent version of the CTCAE criteria
Response up to 2 years a combination of the revised RECIST 1.1 criteria and the guidelines for Prostate Cancer Working Group 3 (PCWG3) Criteria
Trial Locations
- Locations (3)
University of Wisconsin Carbone Cancer Center
🇺🇸Madison, Wisconsin, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States