MedTrace Logo

Study of ORIC-101 in Combination With Enzalutamide

NCT04033328 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2023-12-15

No results posted yet for this study

Summary

The purpose of this study is to establish the recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-101 in combination with enzalutamide (Xtandi®) when administered to patients with metastatic prostate cancer progressing on enzalutamide.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

ORIC-101

ORIC-101 once daily in each 28-day cycle

DRUG

enzalutamide 40 MG oral capsule [Xtandi]

160 mg once daily in each 28-day cycle

Sponsors & Collaborators

  • ORIC Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Pratik S. Multani, MD · ORIC Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-28
Primary Completion
2022-11-22
Completion
2023-12-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04033328 on ClinicalTrials.gov