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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 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial continues darolutamide treatment for patients who were part of a previous study and are believed to benefit from it. Darolutamide helps by blocking hormones that can make cancer cells grow. Patients will keep taking the same dosage and visit their doctors regularly. Darolutamide has been shown to slow cancer spread and improve survival in patients with nonmetastatic castration-resistant prostate cancer.

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.
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.
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 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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%
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
2,274 Previous Clinical Trials
25,531,703 Total Patients Enrolled

Media Library

Cancer Research Study Groups: Darolutamide (BAY1841788)
~317 spots leftby Jun 2028
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