SOC2011
20 Apr 2022
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 Type | Prostate |
|---|---|
| Trial Type | Treatment |
| Phase | Phase I |
| Age Range | 18 years and older |
| Sex | Male |
| Tumour Stream | - |
| Cancer Stage | Metastatic or Widespread |
| Anticipated Start Date | 2021-03-30 |
| Anticipated End Date | 2023-06-01 |
Participating Hospitals
| Hospital | Southern Oncology Clinical Research Unit |
|---|---|
| Clinical Trial Coordinator | Meggan O'Riley |
| Meggan.ORiley@socru.org.au | |
| Phone | 0491 679 039 |
| Principal Investigator | Dr Sina Vatandoust |
| Recruitment Status | Recruiting |