Status:
TERMINATED
Study of PCUR-101 in Combination With ADT in Patients With mCRPC
Lead Sponsor:
Pellficure Pharmaceuticals, Inc
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
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 maximu...
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 accordin...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04677855
Start Date
March 30 2021
End Date
November 20 2023
Last Update
April 10 2024
Active Locations (4)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109
2
Nebraska Cancer Specialist
Omaha, Nebraska, United States, 68130
3
St. George Private Hospital
Kogarah, New South Wales, Australia, 2217
4
Southern Oncology Clinical Research
Bedford Park, South Australia, Australia, 5042