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NCT05617885 · ClinicalTrials.gov registry record · Phase 1

Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer

A Phase 1 study of Prostate Cancer and Metastatic Prostate Cancer, sponsored by Praful Ravi, MB BCHir, MRCP.

Active
Registry status
Phase 1
Development phase
9
Enrollment target
1
Study location

NCT05617885 is a Phase 1 study of Prostate Cancer and Metastatic Prostate Cancer that is active but no longer recruiting, run by Praful Ravi, MB BCHir, MRCP. The registered enrollment target is 9 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05617885, a Phase 1 study of Prostate Cancer and Metastatic Prostate Cancer, is active but no longer recruiting, sponsored by Praful Ravi, MB BCHir, MRCP.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
9 participants
Enrollment target
1
Study location

Study Summary

This research study is trying to determine the safety and efficacy of the combination of two oral drugs, abemaciclib and darolutamide, with androgen deprivation therapy (ADT) in the treatment of metastatic, non-metastatic, and advanced prostate cancers. The first phase of the study is to establish a recommended dose for the second phase. The names of the study drugs and interventions involved in this study are: * Darolutamide * Abemaciclib * Androgen deprivation therapy (ADT) - this includes several different treatments, including Gonadotropin-Releasing Hormone (GnRH) antagonists and agonists It is expected that about 93 people will take part in the research study. Treatment is expected to last 6 months with a follow up period of up to 4.5 years.

Interventions

  • DRUG Darolutamide
  • DRUG Abemaciclib
  • DRUG Degarelix
  • DRUG GNRH-A Leuprolide Acetate
  • DRUG GNRH-A Goserelin

Study Locations (1)

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2023-08-09
Est. Completion 2026-06-01
Phase Phase 1

Sponsor

Praful Ravi, MB BCHir, MRCP

1 total trials

What the Registry Record Tells You About NCT05617885

The ClinicalTrials.gov registry entry for NCT05617885 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 9 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 (99% lower). The listed sponsor is Praful Ravi, MB BCHir, MRCP, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 5 interventions - of which Darolutamide is the first listed.

NCT05617885 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05617885 about?

NCT05617885 is a clinical study titled "Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer". This research study is trying to determine the safety and efficacy of the combination of two oral drugs, abemaciclib and darolutamide, with androgen deprivation therapy (ADT) in the treatment of metastatic, non-metastatic, and advanced prostate cancers. The first phase of the study is to establish a...

What is the current status of trial NCT05617885?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2023-08-09. Estimated completion is 2026-06-01.

What conditions does trial NCT05617885 study?

This clinical trial studies the following conditions: Prostate Cancer, Metastatic Prostate Cancer, Non-metastatic Prostate Cancer.

What interventions are being tested in trial NCT05617885?

The interventions under investigation include: Darolutamide (DRUG), Abemaciclib (DRUG), Degarelix (DRUG), GNRH-A Leuprolide Acetate (DRUG), GNRH-A Goserelin (DRUG).

Who is sponsoring clinical trial NCT05617885?

This trial is sponsored by Praful Ravi, MB BCHir, MRCP, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05617885 being conducted?

This trial has 1 study location across Massachusetts. 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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