A Phase I Study of PCUR-101 in Combination With Androgen Suppression Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer

• Status: Terminated
• Trial end date: 2019-09-17
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pellficure Pharmaceuticals, Inc
• Treatments: Androgens

Criteria

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