Prostatic NeoplasmsPhase 1NCT02123758
A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study testing Abiraterone Acetate, Prednisone and JNJ-56021927 in people with Prostatic Neoplasms and Metastatic Castration-Resistant Prostate Cancer, run by Aragon Pharmaceuticals, Inc. at 7 sites in 4 countries.
Trial summary
The purpose of this study is to investigate potential drug-drug interaction (DDI) between JNJ-56021927 and abiraterone acetate and between JNJ-56021927 and prednisone, determine safety of the combination and evaluate in a descriptive manner the efficacy in these participants. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Prostatic Neoplasms, Metastatic Castration-Resistant Prostate Cancer
- What is being tested?
- Abiraterone Acetate, Prednisone and JNJ-56021927
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 9 Jul 2014to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Documentation of metastatic disease
- Prostate cancer progression
- Surgically or medically castrated, with testosterone levels of less than (<) 50 nanogram per deciliter (ng/dL)
- Adequate bone marrow and organ function
Who cannot join
- Known brain metastases
- Pathological finding consistent with small cell carcinoma of the prostate
- Administration of an investigational agent within 4 weeks of Treatment Cycle 1, Day 1
- Chemotherapy, or immunotherapy for the treatment of prostate cancer within 4 weeks of Treatment Cycle 1, Day 1
- Therapies that must be discontinued or substituted prior to Treatment Cycle 1, Day 1 include the following: Medications known to lower the seizure threshold; Herbal and non-herbal products that may decrease prostate specific antigen (PSA) levels (that is, saw palmetto, pomegranates or pomegranate juice); Medications known to induce drug metabolizing enzymes such as dexamethasone, rifampicin, carbamazepine, phenytoin, phenobarbital, St. John's wort, etc.; and, potent inhibitors of CYP3A4 or CYP2C8
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
United States3 sites
Study site
Houston, Texas
Study site
Los Angeles, California
Study site
San Francisco, California
Canada2 sites
Study site
Montreal, Quebec
Study site
Vancouver, British Columbia
About this study
Official title: A Drug-Drug Interaction, Safety and Efficacy Study With JNJ-56021927 (ARN-509) and Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer
The purpose of this study is to investigate potential drug-drug interaction (DDI) between JNJ-56021927 and abiraterone acetate and between JNJ-56021927 and prednisone, determine safety of the combination and evaluate in a descriptive manner the efficacy in these participants. It will also, potentially provide dosing recommendations for abiraterone acetate in future studies when combined with JNJ-56021927.
Read the detailed description
This is a multicenter, open-label (participants will know the identity of study drug received) study in participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC). The study is a single sequence design (ie, all participants will take abiraterone acetate + prednisone [AAP] once daily on Days 1-7 of Treatment Cycle 1 and then proceed with combined daily intake of AAP+JNJ-56021927 from Treatment Cycle 1, Day 8 through to the end of treatment [ie, for up to an expected duration of approximately 18 months] and will be conducted as two cohorts (group of participant's). The study will consist of a 28-day screening phase to determine eligibility, an open-label treatment phase consisting of 28-day treatment cycles, and a 30-day follow-up phase for collection of adverse events (AE) after last dose of study drug. Participants will have blood samples collected during the study to evaluate pharmacokinetics, safety, and antitumor activity (PSA). Participant safety will also be monitored by the collection of adverse events. Imaging assessments for disease evaluation will be planned at discretion of the Investigator. Once all participants have completed study treatment up to Cycle 3 Day 1, a data cutoff is planned to evaluate the short term safety profile of the combination and to complete the PK analysis up to the cutoff date. All participants will continue on study (ie, to receive treatment) until disease progression, withdrawal of consent, lost to follow-up, or the occurrence of unacceptable toxicity. The end of the study is defined when all participants have completed treatment. Participant's safety will be monitored throughout the study.
- Being tested
- Abiraterone Acetate, Prednisone, JNJ-56021927
- Keywords
- Prostatic Neoplasms, Metastatic Castration-Resistant Prostate Cancer (mCRPC), Prostate cancer, Abiraterone Acetate (ZYTIGA), Prednisone, JNJ-56021927
- 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
Also called ZYTIGA
Administered orally (by mouth) once daily in morning at a dose of 1000 mg for up to the end of treatment (EoT) visit (ie, for up to approximately 18 months).
PrednisoneDrug
Administered orally twice a day at a dose of 5mg for up to the end of treatment (EoT) visit (ie, for up to approximately 18 months).
JNJ-56021927Drug
Administered orally once daily in morning at a dose of 240 mg starting on Day 8, Treatment Cycle 1 for up to the end of treatment (EoT) visit (ie, for up to approximately 18 months).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive abiraterone acetate (AA) along with prednisone on Day 1, Treatment Cycle 1 up to Day 7, Treatment Cycle 1; followed by combined intake of abiraterone acetate + prednisone (AAP) + JNJ-56021927 from Day 8, Treatment Cycle 1 up to the end of treatment (EoT) visit (ie, up to approximately 18 months). On Day 8, Treatment Cycle 2 participants will receive JNJ-56021927, 1 hour after intake of AA and prednisone. Breakfast will be offered approximately 30 minutes after intake of JNJ-56021927. Treatment cycles will be of 28 days. Receives: Drug: Abiraterone Acetate; Drug: Prednisone; Drug: JNJ-56021927 |
| Cohort 2 | Experimental | Participants will receive abiraterone acetate (AA) along with prednisone on Day 1, Treatment Cycle 1 up to Day 7, Treatment Cycle 1; followed by combined intake of AAP + JNJ-56021927 from Day 8, Treatment Cycle 1 up to the end of treatment (EoT) visit (ie, up to approximately 18 months). On Days 7 and 36, participants will receive AA and prednisone together. On Day 8, Treatment Cycle 2 participants will receive JNJ-56021927, 1 hour after intake of AAP. Treatment cycles will be of 28 days. Receives: Drug: Abiraterone Acetate; Drug: Prednisone; Drug: JNJ-56021927 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-time Curve From Time Zero to Time 24 Hours (AUC [0-24]) of abiraterone
The AUC (0-24) is area under the plasma concentration-time curve from time zero to time 24 hours.
Measured: Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)
Maximum plasma concentration (Cmax) of abiraterone, prednisone and its metabolite prednisolone
The Cmax is the maximum observed plasma concentration.
Measured: Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)
Area Under the Plasma Concentration-time Curve From Time Zero to Time 12 Hours (AUC [0-12]) of prednisone and its metabolite prednisolone
The AUC (0-12) is area under the plasma concentration-time curve from time zero to time 12 hours.
Measured: Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)
Secondary outcomes (4)
Area Under the Plasma Concentration Curve (AUC [0- 24h]) of JNJ-56021927 and its metabolite JNJ-56142060
The AUC (0-24) is area under the plasma concentration-time curve from time zero to time 24 hours.
Measured: Day 36 (Treatment Cycle 2), on Day 57 (Treatment Cycle 3)
Maximum plasma concentration (Cmax) of JNJ-56021927 and its metabolite JNJ-56142060
The Cmax is the maximum observed plasma concentration.
Measured: Day 36 (Treatment Cycle 2), on Day 57 (Treatment Cycle 3)
Change in prostate specific antigen (PSA)
Prostate-specific antigen (PSA) is a protein produced by cells of the prostate gland.
Measured: Up to the end of the treatment phase (approximately 18 months)
Maximal decline in prostate specific antigen (PSA)
Prostate-specific antigen (PSA) is a protein produced by cells of the prostate gland.
Measured: Up to the end of the treatment phase (approximately 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 start9 Jul 2014
- Primary completion27 Jun 2016
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aragon Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aragon Pharmaceuticals, Inc. Clinical Trial, Study director, Aragon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123758
- Sponsor's protocol ID
- CR104358
- Other IDs
- 56021927PCR1010, 2014-001426-14, 2014
- Status last verified
- Nov 2026
- First submitted
- 21 Apr 2014
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Drug-Drug Interaction, Safety and Efficacy Study With JNJ-56021927 (ARN-509) and Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT02123758
- Acronym / sponsor ID
- CR104358
- Keywords
- Prostatic Neoplasms, Metastatic Castration-Resistant Prostate Cancer (mCRPC), Prostate cancer, Abiraterone Acetate (ZYTIGA), Prednisone, JNJ-56021927
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Aragon Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2014 (actual)
- Primary completion
- 27 Jun 2016 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- 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 investigate potential drug-drug interaction (DDI) between JNJ-56021927 and abiraterone acetate and between JNJ-56021927 and prednisone, determine safety of the combination and evaluate in a descriptive manner the efficacy in these participants. It will also, potentially provide dosing recommendations for abiraterone acetate in future studies when combined with JNJ-56021927.
Detailed description
This is a multicenter, open-label (participants will know the identity of study drug received) study in participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC). The study is a single sequence design (ie, all participants will take abiraterone acetate + prednisone [AAP] once daily on Days 1-7 of Treatment Cycle 1 and then proceed with combined daily intake of AAP+JNJ-56021927 from Treatment Cycle 1, Day 8 through to the end of treatment [ie, for up to an expected duration of approximately 18 months] and will be conducted as two cohorts (group of participant's). The study will consist of a 28-day screening phase to determine eligibility, an open-label treatment phase consisting of 28-day treatment cycles, and a 30-day follow-up phase for collection of adverse events (AE) after last dose of study drug. Participants will have blood samples collected during the study to evaluate pharmacokinetics, safety, and antitumor activity (PSA). Participant safety will also be monitored by the collection of adverse events. Imaging assessments for disease evaluation will be planned at discretion of the Investigator. Once all participants have completed study treatment up to Cycle 3 Day 1, a data cutoff is planned to evaluate the short term safety profile of the combination and to complete the PK analysis up to the cutoff date. All participants will continue on study (ie, to receive treatment) until disease progression, withdrawal of consent, lost to follow-up, or the occurrence of unacceptable toxicity. The end of the study is defined when all participants have completed treatment. Participant's safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Abiraterone Acetate, Drug: Prednisone, Drug: JNJ-56021927Participants will receive abiraterone acetate (AA) along with prednisone on Day 1, Treatment Cycle 1 up to Day 7, Treatment Cycle 1; followed by combined intake of abiraterone acetate + prednisone (AAP) + JNJ-56021927 from Day 8, Treatment Cycle 1 up to the end of treatment (EoT) visit (ie, up to approximately 18 months). On Day 8, Treatment Cycle 2 participants will receive JNJ-56021927, 1 hour after intake of AA and prednisone. Breakfast will be offered approximately 30 minutes after intake of JNJ-56021927. Treatment cycles will be of 28 days. |
| Cohort 2 | Experimental | Drug: Abiraterone Acetate, Drug: Prednisone, Drug: JNJ-56021927Participants will receive abiraterone acetate (AA) along with prednisone on Day 1, Treatment Cycle 1 up to Day 7, Treatment Cycle 1; followed by combined intake of AAP + JNJ-56021927 from Day 8, Treatment Cycle 1 up to the end of treatment (EoT) visit (ie, up to approximately 18 months). On Days 7 and 36, participants will receive AA and prednisone together. On Day 8, Treatment Cycle 2 participants will receive JNJ-56021927, 1 hour after intake of AAP. Treatment cycles will be of 28 days. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Documentation of metastatic disease
- Prostate cancer progression
- Surgically or medically castrated, with testosterone levels of less than (<) 50 nanogram per deciliter (ng/dL)
Key exclusion criteria (5 listed)
- Known brain metastases
- Pathological finding consistent with small cell carcinoma of the prostate
- Administration of an investigational agent within 4 weeks of Treatment Cycle 1, Day 1
- Chemotherapy, or immunotherapy for the treatment of prostate cancer within 4 weeks of Treatment Cycle 1, Day 1
- Therapies that must be discontinued or substituted prior to Treatment Cycle 1, Day 1 include the following: Medications known to lower the seizure threshold; Herbal and non-herbal products that may decrease prostate specific antigen (PSA) levels (that is, saw palmetto, pomegranates or pomegranate juice); Medications known to induce drug metabolizing enzymes such as dexamethasone, rifampicin, carbamazepine, phenytoin, phenobarbital, St. John's wort, etc.; and, potent inhibitors of CYP3A4 or CYP2C8
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 AcetateAlso: ZYTIGAAdministered orally (by mouth) once daily in morning at a dose of 1000 mg for up to the end of treatment (EoT) visit (ie, for up to approximately 18 months). | Drug | Cohort 1, Cohort 2 |
| PrednisoneAdministered orally twice a day at a dose of 5mg for up to the end of treatment (EoT) visit (ie, for up to approximately 18 months). | Drug | Cohort 1, Cohort 2 |
| JNJ-56021927Administered orally once daily in morning at a dose of 240 mg starting on Day 8, Treatment Cycle 1 for up to the end of treatment (EoT) visit (ie, for up to approximately 18 months). | Drug | Cohort 1, Cohort 2 |
Primary outcome
Area Under the Plasma Concentration-time Curve From Time Zero to Time 24 Hours (AUC [0-24]) of abiraterone
Time frame: Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)
The AUC (0-24) is area under the plasma concentration-time curve from time zero to time 24 hours.
Maximum plasma concentration (Cmax) of abiraterone, prednisone and its metabolite prednisolone
Time frame: Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)
The Cmax is the maximum observed plasma concentration.
Area Under the Plasma Concentration-time Curve From Time Zero to Time 12 Hours (AUC [0-12]) of prednisone and its metabolite prednisolone
Time frame: Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)
The AUC (0-12) is area under the plasma concentration-time curve from time zero to time 12 hours.
4 secondary outcomes
Area Under the Plasma Concentration Curve (AUC [0- 24h]) of JNJ-56021927 and its metabolite JNJ-56142060
Time frame: Day 36 (Treatment Cycle 2), on Day 57 (Treatment Cycle 3)
Maximum plasma concentration (Cmax) of JNJ-56021927 and its metabolite JNJ-56142060
Time frame: Day 36 (Treatment Cycle 2), on Day 57 (Treatment Cycle 3)
Change in prostate specific antigen (PSA)
Time frame: Up to the end of the treatment phase (approximately 18 months)
Maximal decline in prostate specific antigen (PSA)
Time frame: Up to the end of the treatment phase (approximately 18 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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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.
Aragon Pharmaceuticals, Inc. Clinical Trial study director
Aragon Pharmaceuticals, Inc.
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abiraterone Acetate, Prednisone and JNJ-56021927 in people with Prostatic Neoplasms and Metastatic Castration-Resistant Prostate Cancer, run by Aragon Pharmaceuticals, Inc. at 7 sites in 4 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 6 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada, Netherlands, United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Area Under the Plasma Concentration-time Curve From Time Zero to Time 24 Hours (AUC [0-24]) of abiraterone (time frame: Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)). The study lists 3 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 3 Nov 2026.