Prostate NeoplasmsNCT01692483
Post-marketing Surveillance Study on the Safety and Effectiveness of Abiraterone Acetate Among Adult Filipino Male Patients With Advanced Metastatic Castration Resistant Prostate Cancer
An observational study of Prostate Neoplasms, run by Janssen Pharmaceutica.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate in male Filipino patients with advanced metastatic castration resistant prostate cancer (CRPC) who have received prior chemotherapy containing a taxane. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Neoplasms
- What is being tested?
- Abiraterone acetate and Prednisone
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Jun 2016
- Phase
- Observational
- 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
Study population: Male Filipino patients with advanced metastatic castration resistant prostate cancer
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
- Received at least 1 but not more than 2 cytotoxic chemotherapy regimens for metastatic castration resistant prostate cancer (CRPC) (at least 1 regimen must have contained a taxane such as docetaxel; if a chemotherapy regimen containing a taxane is used more than once, this will be considered as 1 regimen)
- Agrees to protocol-defined use of effective contraception
- Laboratory values within protocol -defined parameters
Who cannot join
- Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
- Abnormal liver function
- Uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg)
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
- Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or left ventricular ejection fraction of <50% at baseline
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- Known brain metastasis
- History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study drug
- Any acute toxicities due to prior chemotherapy or radiotherapy that have not resolved to a NCI-CTCAE (Version 4.0) Grade of <=1
- Prior systemic treatment with an azole drug (eg, fluconazole, itraconazole, ketoconazole) within 4 weeks of Cycle 1, Day 1
- Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
- Participation in an investigational drug trial within 30 days prior to selection
- Known hypersensitivity to abiraterone acetate, or to any of the components in the formulation
About this study
Official title: Post-marketing Surveillance Study on the Safety and Effectiveness of Abiraterone Acetate Among Adult Filipino Male Patients With Metastatic Advanced Prostate Cancer
The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate in male Filipino patients with advanced metastatic castration resistant prostate cancer (CRPC) who have received prior chemotherapy containing a taxane.
Read the detailed description
This is an open-label (identity of assigned study drug will be known), observational study to evaluate the safety and efficacy of abiraterone acetate in male Filipino patients with advanced metastatic CRPC who have received prior chemotherapy containing a taxane. Approximately 50 patients will be enrolled. Abiraterone acetate will be administered according to the approved product insert with a low-dose glucocorticoid (prednisone or prednisolone). Patient assessments will be based on the accepted clinical practice in the Philippines. Patients will be monitored for 40 weeks.
- Conditions
- Prostate Neoplasms
- Being tested
- Abiraterone acetate, Prednisone
- Keywords
- Prostate neoplasms, Prostate cancer, Castration resistant prostate cancer, Hormone refractory prostate cancer, Abiraterone acetate, Taxane
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone acetateDrug
Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily
PrednisoneDrug
Prednisone or prednisolone 5 mg tablet taken orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| Abiraterone acetate plus prednisone | Not described Receives: Drug: Abiraterone acetate; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants affected by an adverse event
Measured: Up to 30 days after the last dose of study medication
Secondary outcomes (1)
Number of patients with disease progression
Measured: Baseline up to Week 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startJul 2013
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Why it stopped: Sponsor determined study is not required according to PFDA Circular 2013-004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- is Janssen Pharmaceutica, Philippines Clinical Trial, Study director, Janssen Pharmaceutica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692483
- Sponsor's protocol ID
- CR100856
- Other IDs
- 212082PCR4003
- Status last verified
- Nov 2015
- First submitted
- 21 Sep 2012
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance Study on the Safety and Effectiveness of Abiraterone Acetate Among Adult Filipino Male Patients With Metastatic Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT01692483
- Acronym / sponsor ID
- CR100856
- Conditions
- Prostate Neoplasms
- Keywords
- Prostate neoplasms, Prostate cancer, Castration resistant prostate cancer, Hormone refractory prostate cancer, Abiraterone acetate, Taxane
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor determined study is not required according to PFDA Circular 2013-004
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 25 Sep 2012 (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 evaluate the safety and efficacy of abiraterone acetate in male Filipino patients with advanced metastatic castration resistant prostate cancer (CRPC) who have received prior chemotherapy containing a taxane.
Detailed description
This is an open-label (identity of assigned study drug will be known), observational study to evaluate the safety and efficacy of abiraterone acetate in male Filipino patients with advanced metastatic CRPC who have received prior chemotherapy containing a taxane. Approximately 50 patients will be enrolled. Abiraterone acetate will be administered according to the approved product insert with a low-dose glucocorticoid (prednisone or prednisolone). Patient assessments will be based on the accepted clinical practice in the Philippines. Patients will be monitored for 40 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abiraterone acetate plus prednisone | – | Drug: Abiraterone acetate, Drug: Prednisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male Filipino patients with advanced metastatic castration resistant prostate cancer
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
- Received at least 1 but not more than 2 cytotoxic chemotherapy regimens for metastatic castration resistant prostate cancer (CRPC) (at least 1 regimen must have contained a taxane such as docetaxel; if a chemotherapy regimen containing a taxane is used more than once, this will be considered as 1 regimen)
- Agrees to protocol-defined use of effective contraception
- Laboratory values within protocol -defined parameters
Key exclusion criteria (13 listed)
- Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
- Abnormal liver function
- Uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg)
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
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 |
|---|---|---|
| Abiraterone acetateAbiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily | Drug | Abiraterone acetate plus prednisone |
| PrednisonePrednisone or prednisolone 5 mg tablet taken orally twice daily | Drug | Abiraterone acetate plus prednisone |
Primary outcome
Number of participants affected by an adverse event
Time frame: Up to 30 days after the last dose of study medication
1 secondary outcome
Number of patients with disease progression
Time frame: Baseline up to Week 40
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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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.
is Janssen Pharmaceutica, Philippines Clinical Trial study director
Janssen Pharmaceutica
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Neoplasms, run by Janssen Pharmaceutica.
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 13 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: withdrawn, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of participants affected by an adverse event (time frame: Up to 30 days after the last dose of study medication). 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 2 Dec 2015.