Official Title
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
Phase 1Lead Sponsor
Pellficure Pharmaceuticals, IncStudy Type
InterventionalStatus
TerminatedIndication/Condition
Metastatic Castration-Resistant Prostate CancerIntervention/Treatment
pcur-101 ...Study Participants
12This 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
PCUR-101 Capsules 25 mg are solid dosage forms for oral administration
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
