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Antiandrogen

Continued Darolutamide Treatment for Cancer

Phase 3
Recruiting
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial is for patients who have already been taking darolutamide and their doctors believe it is still beneficial for them to continue. Patients will be transferred from previous studies and continue on the same dosage. There will be regular doctor visits like before.

Who is the study for?
This trial is for patients who have been part of a previous Bayer-supported study on Darolutamide and are seeing benefits from its use. They must be able to consent, follow the study's rules, not have met any discontinuation criteria previously, and agree to continue using birth control.Check my eligibility
What is being tested?
The trial continues treatment with Darolutamide (Nubeqa) for cancer patients carried over from prior studies. The dosage remains the same, and participants will visit doctors as before to assess the ongoing effectiveness and safety of the drug.See study design
What are the potential side effects?
While specific side effects aren't listed here, they may include those observed in earlier trials or new ones that arise from prolonged use. Patients should report any adverse reactions to their healthcare provider.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of drug-related TEAEs
Incidence of drug-related TESAEs
Incidence of treatment-emergent adverse events (TEAEs)
+1 more
Secondary outcome measures
Number of dose modifications

Side effects data

From 2021 Phase 3 trial • 1509 Patients • NCT02200614
15%
Fatigue
14%
Arthralgia
12%
Back pain
10%
Anaemia
9%
Hypertension
9%
Constipation
9%
Diarrhoea
8%
Urinary tract infection
7%
Pain in extremity
7%
Hot flush
7%
Weight decreased
7%
Haematuria
6%
Headache
6%
Nausea
6%
Oedema peripheral
6%
Nasopharyngitis
6%
Fall
5%
Asthenia
5%
Musculoskeletal pain
5%
Dizziness
5%
Pollakiuria
4%
Insomnia
4%
Upper respiratory tract infection
4%
Abdominal pain
4%
Blood creatinine increased
4%
Influenza
4%
Decreased appetite
4%
Urinary retention
3%
Dysuria
3%
Atrial fibrillation
3%
Urinary incontinence
3%
Rash
3%
Rib fracture
3%
Gynaecomastia
3%
Cough
3%
Dyspnoea
3%
Weight increased
3%
Myalgia
3%
Osteoarthritis
3%
Depression
2%
Vomiting
2%
Muscle spasms
2%
Aspartate aminotransferase increased
2%
Pelvic pain
2%
Neutropenia
2%
Cataract
2%
Pneumonia
2%
Contusion
2%
Pruritus
2%
Abdominal pain upper
2%
Pyrexia
2%
Bronchitis
2%
Hyperkalaemia
2%
Nephrolithiasis
2%
Nocturia
1%
Ischaemic stroke
1%
Pulmonary embolism
1%
Cardiac failure
1%
Death
1%
General physical health deterioration
1%
Cerebrovascular accident
1%
Hydronephrosis
1%
Acute kidney injury
1%
Alanine aminotransferase increased
1%
Acute myocardial infarction
1%
Myocardial infarction
1%
Urinary tract obstruction
1%
COVID-19
1%
Hypokalaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Darolutamide (DB+OL)
Placebo+Darolutamide (CO)
Placebo (DB)
Darolutamide (DB)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Darolutamide (BAY1841788)Experimental Treatment1 Intervention
Participants enrolled in the current study will use the dose they were assigned to in the feeder study they come from.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Darolutamide (Nubeqa, BAY1841788)
2024
Completed Phase 3
~4180

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,240 Previous Clinical Trials
25,332,099 Total Patients Enrolled

Media Library

Cancer Research Study Groups: Darolutamide (BAY1841788)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other examples of research on Darolutamide (Nubeqa, BAY1841788)?

"There are 25 ongoing Darolutamide (Nubeqa, BAY1841788) studies, 9 of which are in Phase 3. These trials are being conducted in Toronto, Ontario and 1385 other locations."

Answered by AI

Is this research being conducted at multiple facilities within the state?

"Currently, there are 36 clinical trial sites actively enrolling patients for this study, including locations in Calgary, Bala-Cynwyd, and Dallas."

Answered by AI

Have there been other similar medical studies in the past?

"Darolutamide (Nubeqa, BAY1841788) has had 25 active clinical trials since 2016, which have taken place in 530 cities across 44 countries. The first study, sponsored by Orion Corporation and Orion Pharma, enrolled 1303 participants and completed Phase 3 in 2016. There have been 13 studies conducted since then."

Answered by AI

How many patients are involved in this clinical trial?

"This clinical trial requires 676 patients that fit the pre-determined eligibility criteria. Patients can enroll at multiple locations, such as the Tom Baker Cancer Centre in Calgary, Alberta and the CHUM - Hopital Notre-Dame in Bala-Cynwyd, Pennsylvania."

Answered by AI

What is the maximum dosage of Darolutamide (Nubeqa, BAY1841788) that a patient can take safely?

"There is existing clinical data that supports the safety of Darolutamide, which is why it received a score of 3."

Answered by AI

Are people signing up to participate in this experiment right now?

"Recently updated on October 6th, 2020, this trial is still actively recruiting participants, as stated on clinicaltrials.gov. This information is corroborated by the original posting date of October 20th, 2020."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer
2020. "Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04464226.
~157 spots leftby Jun 2025
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