Title
A Phase 2, Single-Arm Study of the CXCR1/2 Inhibitor SX-682 Plus Enzalutamide in Men with Abiraterone-Resistant Metastatic Castration Resistant Prostate Cancer (mCRPC)

Description
A Phase 2, Single-Arm Study of the CXCR1/2 Inhibitor SX-682 Plus Enzalutamide in Men with Abiraterone-Resistant Metastatic Castration Resistant Prostate Cancer, the SYNERGY-201 Trial

Objective
The primary objective is to demonstrate that 55% or more of patients treated with SX-682 and enzalutamide will achieve CB. CB is a categorical composite endpoint defined as 1) iRECIST iCR or iPR, 2) PSA50 or 3) stable disease by iRECIST and PCWG3 bone scan criteria for at least 6 months.

Secondary Objectives
1. Safety and tolerability using NCI CTC v5.0 criteria.
2. PFS1 (time from the date study treatment starts to the earliest progression event from iRECIST (i.e., iPFS), PCWG3 bone scan criteria, or death) and PFS2 (same as PFS1 but using RECIST 1.1 instead of iRECIST).
3. Overall survival (the time from the start of study treatment until death due to any cause).
4. iRECIST, RECIST 1.1, PSA50, PSA PFS, ?SOM, symptomatic skeletal events (SSEs).
5. To describe the concentration of blood-based biomarker over time, including PSA, neuron-specific enolase (NSE), chromogranin-A, LDH, and alkaline phosphatase.
6. To describe the pharmacokinetics of SX-682 and enzalutamide in combination as compared to either agent alone (historic data)

Treatment The goal of this clinical trial is to study the combination of SX-682 plus enzalutamide in men with metastatic castration resistant prostate cancer (mCRPC) who have failed abiraterone.

Key Eligibility For full study eligibility, see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Prostate

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital