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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
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 moreSecondary outcome measures
Number of dose modifications
Side effects data
From 2021 Phase 3 trial • 1509 Patients • NCT0220061415%
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%
Muscle spasms
2%
Vomiting
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
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Who is running the clinical trial?
BayerLead Sponsor
2,249 Previous Clinical Trials
25,332,905 Total Patients Enrolled
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Research Study Groups:
This trial has the following groups:- Group 1: Darolutamide (BAY1841788)
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