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NCT02799602 · ClinicalTrials.gov registry record · Phase 3

Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

A Phase 3 study, sponsored by Bayer.

Completed
Registry status
Phase 3
Development phase
1,306
Enrollment target

NCT02799602 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 1,306 participants.

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The verdict

NCT02799602, a Phase 3 study, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 3
Development phase
1,306 participants
Enrollment target

Study Summary

The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.

Interventions

  • DRUG Placebo
  • DRUG Docetaxel
  • DRUG BAY1841788 / darolutamide (ODM-201)
  • DRUG Standard ADT (androgen deprivation therapy)

Trial Details

FieldValue
Enrollment Target 1,306 participants
Start Date 2016-11-30
Est. Completion 2023-04-11
Phase Phase 3

Sponsor

Bayer

591 total trials

What the Registry Record Tells You About NCT02799602

The ClinicalTrials.gov registry entry for NCT02799602 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,306 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT02799602 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02799602 about?

NCT02799602 is a clinical study titled "Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer". The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.

What is the current status of trial NCT02799602?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,306 participants. The study started on 2016-11-30. Estimated completion is 2023-04-11.

What interventions are being tested in trial NCT02799602?

The interventions under investigation include: Placebo (DRUG), Docetaxel (DRUG), BAY1841788 / darolutamide (ODM-201) (DRUG), Standard ADT (androgen deprivation therapy) (DRUG).

Who is sponsoring clinical trial NCT02799602?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.