Prostate CancerPhase 1NCT02468284
Pharmacokinetics of Degarelix in Chinese Patients With Prostate Cancer
A Phase 1 study testing degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 1 site in China.
Trial summary
The purpose of this trial is to look at how much a new trial drug get into body, such as when the drug concentration in your body reaches peak and how high the peak value is. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- degarelix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to 10 Oct 2017
- Phase
- Phase 1
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), for which endocrine therapy (except for neoadjuvant hormonal therapy) is indicated
- Has a Prostate-specific Antigen (PSA) level ≥2.0 ng/mL at Screening
- Has a screening serum testosterone level >150 ng/dL
- Has an Eastern Cooperative Oncology Group (ECOG) score of ≤2
Who cannot join
- Has had previous or is currently under hormonal management of prostate cancer. However, hormonal therapy for a maximum duration of 6 months is accepted. This treatment should have been terminated at least 6 months prior to the Screening Visit
- Is currently treated with a 5-alpha reductase inhibitor
- Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
- Is in need of neoadjuvant hormonal therapy
- Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital (there may be other sites in this country)
Beijing
About this study
Official title: An Open-label, Multi-Centre Trial Investigating Pharmacokinetics of Degarelix After a Starting Dose of 240 mg (40 mg/mL) Followed by Six Maintenance Doses of 80 mg (20 mg/mL) in Chinese Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
The purpose of this trial is to look at how much a new trial drug get into body, such as when the drug concentration in your body reaches peak and how high the peak value is.
- Conditions
- Prostate Cancer
- Being tested
- degarelix
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
degarelixDrug
Also called Firmagon
| Study group | Role | What they receive |
|---|---|---|
| Degarelix | Experimental | Not described Receives: Drug: degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration observed (Cmax)
Measured: Day 0 - 196
Time of Cmax after subcutaneous administration (Tmax)
Measured: Day 0 - 196
Maximum plasma concentration observed (Cmax)
Measured: Day 0 - 28
Maximum plasma concentration observed (Cmax)
Measured: Day 168 - 196
Time of Cmax after subcutaneous administration (Tmax)
Measured: Day 0 - 28
Time of Cmax after subcutaneous administration (Tmax)
Measured: Day 168 - 196
Area under the plasma concentration-time curve during a drug dosing interval (AUC)
Measured: Day 0 - 28
Area under the plasma concentration-time curve during a drug dosing interval (AUC)
Measured: Day 168 - 196
Secondary outcomes (1)
Plasma trough levels of degarelix
Measured: At Days 28, 56, 168 and 196
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJul 2015
- Primary completion13 Oct 2016
- Study completion10 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468284
- Sponsor's protocol ID
- 000200
- Status last verified
- Oct 2017
- First submitted
- 8 Jun 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-Centre Trial Investigating Pharmacokinetics of Degarelix After a Starting Dose of 240 mg (40 mg/mL) Followed by Six Maintenance Doses of 80 mg (20 mg/mL) in Chinese Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT02468284
- Acronym / sponsor ID
- 000200
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- 13 Oct 2016 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 10 Jun 2015 (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 trial is to look at how much a new trial drug get into body, such as when the drug concentration in your body reaches peak and how high the peak value is.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Degarelix | Experimental | Drug: degarelix |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), for which endocrine therapy (except for neoadjuvant hormonal therapy) is indicated
- Has a Prostate-specific Antigen (PSA) level ≥2.0 ng/mL at Screening
- Has a screening serum testosterone level >150 ng/dL
- Has an Eastern Cooperative Oncology Group (ECOG) score of ≤2
Key exclusion criteria (5 listed)
- Has had previous or is currently under hormonal management of prostate cancer. However, hormonal therapy for a maximum duration of 6 months is accepted. This treatment should have been terminated at least 6 months prior to the Screening Visit
- Is currently treated with a 5-alpha reductase inhibitor
- Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
- Is in need of neoadjuvant hormonal therapy
- Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy
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 |
|---|---|---|
| degarelixAlso: Firmagon | Drug | Degarelix |
Primary outcome
Maximum plasma concentration observed (Cmax)
Time frame: Day 0 - 196
Time of Cmax after subcutaneous administration (Tmax)
Time frame: Day 0 - 196
Maximum plasma concentration observed (Cmax)
Time frame: Day 0 - 28
Maximum plasma concentration observed (Cmax)
Time frame: Day 168 - 196
Time of Cmax after subcutaneous administration (Tmax)
Time frame: Day 0 - 28
Time of Cmax after subcutaneous administration (Tmax)
Time frame: Day 168 - 196
Area under the plasma concentration-time curve during a drug dosing interval (AUC)
Time frame: Day 0 - 28
Area under the plasma concentration-time curve during a drug dosing interval (AUC)
Time frame: Day 168 - 196
1 secondary outcome
Plasma trough levels of degarelix
Time frame: At Days 28, 56, 168 and 196
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 26 Oct 2017.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Clinical Development Support study director
Ferring Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 1 site in China.
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 4 inclusion and 5 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 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximum plasma concentration observed (Cmax) (time frame: Day 0 - 196). The study lists 8 primary outcomes in all. 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 26 Oct 2017.