Castration-Resistant Prostate CancerPhase 2NCT02124668
A Study to Monitor the Safety of Enzalutamide in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
A Phase 2 study testing Enzalutamide in people with Castration-Resistant Prostate Cancer and Prostate Cancer, run by Astellas Pharma Europe B.V. at 4 sites in 2 countries.
Trial summary
The purpose of this study is to monitor the safety of enzalutamide in patients with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Castration-Resistant Prostate Cancer, Prostate Cancer
- What is being tested?
- Enzalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 23 Sep 2014to 25 May 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject has histologically or cytologically confirmed adenocarcinoma of the prostate
- Subject has ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) and plans to maintain throughout the study period or has had a prior orchiectomy (i.e., surgical or medical castration)
- Subject has had at least one prior chemotherapy regimen for metastatic castration-resistant prostate cancer with at least one regimen containing docetaxel
- Subject has progressive disease and indication for change of antineoplastic regimen
- Subject has no known or suspected brain metastasis
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
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- Subject is able to swallow the study drug and comply with study requirements
- There is no comparable or satisfactory alternative therapy to treat the subject's disease
- Subject agrees not to participate in another interventional study while on treatment
Who cannot join
- Subject has severe concurrent disease, infection, or co-morbidity that would make the subject inappropriate for enrollment
- Subject's absolute neutrophil count is < 1000/μL, or platelet count < 100,000/μL, or hemoglobin < 6.2 mmol/L (or < 10 g/dL)
- Subject's total bilirubin is ≥ 1.5 x upper limit of normal (ULN) (except for subjects with documented Gilbert's disease) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is ≥ 2.5x ULN
- Subject's estimated creatinine clearance is less than 30 mL/min by the Cockcroft and Gault formula
- Subject has albumin ≤ 30 g/L (or ≤ 3.0 g/dL)
- Subject has received anti-androgen therapy (e.g. bicalutamide), chemotherapy, or biologic therapy for prostate cancer (other than bone targeted agents such as bisphosphonates or denosumab, gonadotropin-releasing hormone (GnRH) analogue therapy, or glucocorticoids which are allowed) within 4 weeks of Day 1
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- Subject has had prior use of abiraterone
- Subject has prior use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g. TAK-700) or targets the androgen receptor (e.g. ARN-509, ODM-201)
- Subject has:
- A history of seizure, including any febrile seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumors, brain metastases,
- A history of loss of consciousness or transient ischemic attack within 12 months of Screening
- Subject has clinical signs suggestive of high or imminent risks for pathological fracture, spinal cord compression and/or cauda equina syndrome
- Subject has a significant cardiovascular disease
- Subject has received investigational therapy within 28 days or 5 half lives, whichever is longer, prior to Screening
- Subject has undergone major surgery within 4 weeks prior to Screening
- Subject has shown a hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene
- Subject has used or plans to use, from 30 days prior to enrollment through the end of the study, medications known to lower the seizure threshold or prolong the QT interval
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
About this study
Official title: A Phase 2, Multicenter, Single-arm, Open Label Study to Monitor the Safety of Enzalutamide in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
The purpose of this study is to monitor the safety of enzalutamide in patients with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.
- Being tested
- Enzalutamide
- Keywords
- Xtandi, MDV3100, Progressive Castration-Resistant Prostate Cancer, Enzalutamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzalutamideDrug
Also called Xtandi, MDV3100
oral
| Study group | Role | What they receive |
|---|---|---|
| Enzalutamide | Experimental | Enzalutamide Receives: Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile of enzalutamide assessed by adverse events (AEs), serious AEs (SAEs), vital signs, electrocardiograms (ECGs) and laboratory measurements
Measured: Up to 30 days after the last dose of enzalutamide or prior to the initiation of another anticancer therapy, whichever comes first (up to 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study start23 Sep 2014
- Primary completion25 May 2017
- Study completion25 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration-Resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124668
- Sponsor's protocol ID
- 9785-CL-0122
- Status last verified
- Nov 2024
- First submitted
- 25 Apr 2014
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Single-arm, Open Label Study to Monitor the Safety of Enzalutamide in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
- ClinicalTrials.gov ID
- NCT02124668
- Acronym / sponsor ID
- 9785-CL-0122
- Keywords
- Xtandi, MDV3100, Progressive Castration-Resistant Prostate Cancer, Enzalutamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Collaborators
- Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
- Study start
- 23 Sep 2014 (actual)
- Primary completion
- 25 May 2017 (actual)
- Study completion
- 25 May 2017 (actual)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to monitor the safety of enzalutamide in patients with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide | Experimental | Drug: EnzalutamideEnzalutamide |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Subject has histologically or cytologically confirmed adenocarcinoma of the prostate
- Subject has ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) and plans to maintain throughout the study period or has had a prior orchiectomy (i.e., surgical or medical castration)
- Subject has had at least one prior chemotherapy regimen for metastatic castration-resistant prostate cancer with at least one regimen containing docetaxel
- Subject has progressive disease and indication for change of antineoplastic regimen
- Subject has no known or suspected brain metastasis
Key exclusion criteria (17 listed)
- Subject has severe concurrent disease, infection, or co-morbidity that would make the subject inappropriate for enrollment
- Subject's absolute neutrophil count is < 1000/μL, or platelet count < 100,000/μL, or hemoglobin < 6.2 mmol/L (or < 10 g/dL)
- Subject's total bilirubin is ≥ 1.5 x upper limit of normal (ULN) (except for subjects with documented Gilbert's disease) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is ≥ 2.5x ULN
- Subject's estimated creatinine clearance is less than 30 mL/min by the Cockcroft and Gault formula
- Subject has albumin ≤ 30 g/L (or ≤ 3.0 g/dL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnzalutamideAlso: Xtandi, MDV3100oral | Drug | Enzalutamide |
Primary outcome
Safety profile of enzalutamide assessed by adverse events (AEs), serious AEs (SAEs), vital signs, electrocardiograms (ECGs) and laboratory measurements
Time frame: Up to 30 days after the last dose of enzalutamide or prior to the initiation of another anticancer therapy, whichever comes first (up to 18 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Europe B.V.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enzalutamide in people with Castration-Resistant Prostate Cancer and Prostate Cancer, run by Astellas Pharma Europe B.V. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Georgia, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety profile of enzalutamide assessed by adverse events (AEs), serious AEs (SAEs), vital signs, electrocardiograms (ECGs) and laboratory measurements (time frame: Up to 30 days after the last dose of enzalutamide or prior to the initiation of another anticancer therapy, whichever comes first (up to 18 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.