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Trials
Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

trialsTrialActive

Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

A phase 3 trial of Darolutamide in advanced solid tumours, run by Bayer, active and no longer recruiting.

Overview Connected4

Overview

Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer is a phase 3 interventional study registered as NCT04464226 by Bayer, with 402 participants enrolled, started 2020-10-20 and due to reach its primary completion in 2028-06-26. Interventions recorded: Darolutamide (Nubeqa, BAY1841788).

Setting

An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies

Phase

Phase 3

Sponsor

Bayer

Registry

Started

2020-10-20

Enrolled

402 enrolled

Connected

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cancers

Metastatic cancer (cancer that has spread)

technologies

Androgen deprivation & AR pathway inhibitors

drugs

ApprovedSmall-molecule AR antagonist

Darolutamide · Nubeqa

companies

Evidence strength48/100 · Emerging

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 3+30
402 enrolled+13
No structured primary endpoint0
Result: active0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sources & links

ClinicalTrials.gov NCT04464226

Data

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Cancers

Metastatic cancer (cancer that has spread)

Technologies

Androgen deprivation & AR pathway inhibitors

Products

Darolutamide

Companies

Bayer

Not yet reviewedNeeds expert (clinical) review. Review this page or see the review queue and roster.

Model panel commentary is coming to this page: machine commentary, not clinical review.

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