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NCT06312670 · ClinicalTrials.gov registry record · Phase 2

Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer

A Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by Pedro Barata, MD, MSc.

Completed
Registry status
Phase 2
Development phase
13
Enrollment target
2
Study locations

NCT06312670 is a Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma that has completed, run by Pedro Barata, MD, MSc. The registered enrollment target is 13 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT06312670, a Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma, has completed, sponsored by Pedro Barata, MD, MSc.

COMPLETED
Registry status
Phase 2
Development phase
13 participants
Enrollment target
2
Study locations

Study Summary

The purpose of this study is to study the effects of EPI-7386 in combination with Enzalutamide on participants diagnosed with prostate cancer. The main goals of this study are to evaluate the antitumor activity of EPI-7386 in combination with enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC), and to evaluate the pharmacokinetics (PK) of EPI-7386 when dosed in combination with enzalutamide. Participants will will take the study drug, EPI-7360, twice a day by mouth and enzalutamide once a day by mouth, alongside clinic visits every two weeks.

Interventions

  • DRUG Enzalutamide
  • DRUG Androgen Deprivation Therapy (ADT)
  • DRUG EPI-7386

Study Locations (2)

Ohio

  • University Hospitals Cleveland Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center - Cleveland
  • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center - Cleveland

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2024-05-16
Est. Completion 2025-01-09
Phase Phase 2

Sponsor

Pedro Barata, MD, MSc

2 total trials

What the Registry Record Tells You About NCT06312670

The ClinicalTrials.gov registry entry for NCT06312670 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Pedro Barata, MD, MSc, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Enzalutamide is the first listed.

NCT06312670 reports 2 study locations spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT06312670 about?

NCT06312670 is a clinical study titled "Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer". The purpose of this study is to study the effects of EPI-7386 in combination with Enzalutamide on participants diagnosed with prostate cancer. The main goals of this study are to evaluate the antitumor activity of EPI-7386 in combination with enzalutamide in metastatic hormone-sensitive prostate can...

What is the current status of trial NCT06312670?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2024-05-16. Estimated completion is 2025-01-09.

What conditions does trial NCT06312670 study?

This clinical trial studies the following conditions: Prostate Cancer, Prostate Adenocarcinoma, Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).

What interventions are being tested in trial NCT06312670?

The interventions under investigation include: Enzalutamide (DRUG), Androgen Deprivation Therapy (ADT) (DRUG), EPI-7386 (DRUG).

Who is sponsoring clinical trial NCT06312670?

This trial is sponsored by Pedro Barata, MD, MSc, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06312670 being conducted?

This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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