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Trial 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.

Acronym:

SOC2011

ACTRN/NCT /ethics:

NCT04677855

Scientific title:

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

Sponsor / Cooperative group:

Pellficure Pharmaceuticals

Trial & Patient Characteristics

Cancer TypeProstate
Trial TypeTreatment
PhasePhase I
Age Range18 years and older
SexMale
Tumour Stream -
Cancer StageMetastatic or Widespread
Anticipated Start Date2021-03-30
Anticipated End Date2023-06-01

Participating Hospitals

HospitalSouthern Oncology Clinical Research Unit
Clinical Trial CoordinatorMeggan O'Riley
EmailMeggan.ORiley@socru.org.au
Phone0491 679 039
Principal InvestigatorDr Sina Vatandoust
Recruitment StatusRecruiting