CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
TRC253drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02987829
NCT02987829Phase 2Completed
CompareCT.gov

An Open-label Phase 1/2A Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of TRC253, an Androgen Receptor Antagonist, in Patients With Metastatic Castration-resistant Prostate Cancer

Tracon Pharmaceuticals Inc.·interventional·Posted Dec 9, 2016·Updated Apr 23, 2021

In Brief

A Phase 2 clinical trial evaluating TRC253 for Metastatic Castrate-resistant Prostate Cancer and Adenocarcinoma, Prostate. Completed, enrolled 72 participants across 5 sites.

Detailed Summary

This is a multi-center, first-in-human, open-label, Phase 1/2A dose-escalation study in which eligible patients with metastatic castration-resistant prostate carcinoma (mCRPC) will receive oral doses of TRC253. The study will be conducted in 2 parts: part 1 (dose escalation) and part 2 (dose expansion).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Castrate-resistant Prostate Cancer, Adenocarcinoma, Prostate
CountriesUnited States
CollaboratorsJanssen Pharmaceutica N.V., Belgium

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 9, 2016
Enrollment StartMay 23, 2017
Primary CompletionOct 6, 2019
Study CompletionNov 9, 2020
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.6 years ago

Interventions

TRC253drug

TRC253 is a high-affinity, small molecule antagonist of the androgen receptor (AR) with inhibitory activity against wild type AR and specific mutated variants of AR. TRC253 blocks AR nuclear translocation as well as AR binding to DNA and is an antagonist of transcription for wild type AR and mutated AR. TRC253 is orally active and does not have agonist activity towards either the wild type or mutated ARs. TRC253 treatment in the Hershberger assay results in complete inhibition of androgen sensitive organ development. TRC253 is efficacious in an LNCaP xenograft model driven by F876L (also known as F877L) mutant AR.