check_circleStudy Completed

Castration-resistant prostate cancer

Bayer Identifier:

18035

ClinicalTrials.gov Identifier:

NCT01429064

EudraCT Number:

2010-022803-24

EU CT Number:

Not Available
Study to learn more about the long-term safety of ODM-201 (Nubeqa, Darolutamide, BAY1841788) and how well the study drug acts in the human body of patients suffering from prostate cancer

Trial purpose

The purpose of the study is to learn more about the long-term safety of ODM-201 (Nubeqa, Darolutamide, BAY1841788) in patients with prostate cancer that keeps growing and has spread to other parts of the body. In addition researchers want to gather information how well patients suffering from this type of prostate cancer respond to treatment with ODM-201. The study medication ODM-201 is an androgen receptor inhibitor tested in men with metastatic castration-resistant prostate cancer (mCRPC).

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - Male patients aged 18 years or older with histologically confirmed adenocarcinoma of the prostate
    - Patients who successfully completed 12 weeks of treatment according to study protocol 3104001 (NCT01317641; Bayer 17829) without any serious drug-related adverse events or dose-limiting toxicities
    - Patient was expected to benefit from participation in the study in the opinion of the investigator
    - Patients with any response or stable disease in Study 3104001 at week 12

  • - Patients who received prior therapy with MDV3100 or any investigational androgen receptor antagonist
    - Patients who received chemotherapy, radiotherapy or any experimental therapy within 4 weeks (within 6 weeks for nitrosoureas and mitomycin C) of the start of study treatment or had not recovered to Grade ≤1 or returned to baseline from any acute treatment-related toxicities of the previous therapy except for alopecia and Grade 2 neuropathy
    - Therapy with oral ketoconazole or CYP17 inhibitor within 30 days prior to the start of study treatment

Trial summary

Enrollment Goal
76
Trial Dates
June 2011 - October 2015
Phase
Phase 2
Could I Receive a placebo
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Faculty Hospital Hradec KrálovéHradec Králové, 500 05, Czech Republic
Completed
East Tallinn Central HospitalTallinn, 10138, Estonia
Completed
Helsinki University Central HospitalHelsinki, 00029, Finland
Completed
Tampere University HospitalTampere, 33521, Finland
Completed
Kuopio University HospitalKuopio, 70211, Finland
Completed
Oulu University HospitalOulu, 90029, Finland
Completed
Turku University HospitalTurku, 20521, Finland
Completed
Institut Gustave RoussyVillejuif, 94805, France
Completed
Hôpital Saint LouisParis, 75745, France
Completed
Queen Elizabeth HospitalBirmingham, B15 2TH, United Kingdom
Completed
Cardiff University And Velindre Cancer CentreCardiff, CF14 2TL, United Kingdom
Completed
Christie Hospital NHS Foundation TrustManchester, M204BX, United Kingdom
Completed
Churchill HospitalOxford, OX3 7LJ, United Kingdom
Completed
Cleveland ClinicCleveland, 44195, United States
Completed
Urology Center ColoradoUrology, 80211, United States
Completed
Carolina Urologic Research CenterMyrtle Beach, 29572, United States
Completed
Eastern CT Hematology And OncologyNorwich, 06360, United States

Primary Outcome

  • Number of participants with adverse events
    date_rangeTime Frame:
    Up 51 months

Secondary Outcome

  • Change in Prostate specific antigen (PSA) since baseline in Study 3104001
    date_rangeTime Frame:
    Up 51 months
  • Time to PSA progression
    date_rangeTime Frame:
    Up 51 months
  • Time on treatment from start of treatment in Study 3104001
    date_rangeTime Frame:
    Up 51 months
  • Changes in soft tissue lesions since baseline in Study 3104001
    date_rangeTime Frame:
    Up 51 months
  • Changes in bone lesions since baseline in Study 3104001
    date_rangeTime Frame:
    Up 51 months
  • Eastern Cooperative Oncology Group (ECOG) performance status
    date_rangeTime Frame:
    Up 51 months
  • Time to radiographic progression
    date_rangeTime Frame:
    Up 51 months
  • Time to Radiographic progression-free survival (rPFS)
    date_rangeTime Frame:
    Up 51 months

Trial design

Safety and tolerability of ODM-201 in patients with castrate-resistant prostate cancer: Open, non-randomised, uncontrolled, multicenter, extension study to Study 3104001
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
6

Additional Information

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