A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer
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ClinicalTrials.gov Identifier: NCT02123758 |
Recruitment Status :
Active, not recruiting
First Posted : April 28, 2014
Last Update Posted : February 26, 2021
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Condition or disease | Intervention/treatment | Phase |
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Prostatic Neoplasms Metastatic Castration-Resistant Prostate Cancer | Drug: Abiraterone Acetate Drug: Prednisone Drug: JNJ-56021927 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 57 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | July 9, 2014 |
Actual Primary Completion Date : | June 27, 2016 |
Estimated Study Completion Date : | October 15, 2021 |

Arm | Intervention/treatment |
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Experimental: Cohort 1
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.
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Drug: Abiraterone Acetate
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).
Other Name: ZYTIGA Drug: Prednisone 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). Drug: JNJ-56021927 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). |
Experimental: Cohort 2
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.
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Drug: Abiraterone Acetate
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).
Other Name: ZYTIGA Drug: Prednisone 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). Drug: JNJ-56021927 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). |
- 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.
- 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) ]The AUC (0-24) is area under the plasma concentration-time curve from time zero to time 24 hours.
- 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) ]The Cmax is the maximum observed plasma concentration.
- Change in prostate specific antigen (PSA) [ Time Frame: Up to the end of the treatment phase (approximately 18 months) ]Prostate-specific antigen (PSA) is a protein produced by cells of the prostate gland.
- Maximal decline in prostate specific antigen (PSA) [ Time Frame: Up to the end of the treatment phase (approximately 18 months) ]Prostate-specific antigen (PSA) is a protein produced by cells of the prostate gland.

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02123758
United States, California | |
Los Angeles, California, United States | |
San Francisco, California, United States | |
United States, Texas | |
Houston, Texas, United States | |
Canada, British Columbia | |
Vancouver, British Columbia, Canada | |
Canada, Quebec | |
Montreal, Quebec, Canada | |
Netherlands | |
Rotterdam, Netherlands | |
United Kingdom | |
Sutton, United Kingdom |
Study Director: | Aragon Pharmaceuticals, Inc. Clinical Trial | Aragon Pharmaceuticals, Inc. |
Responsible Party: | Aragon Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT02123758 |
Other Study ID Numbers: |
CR104358 56021927PCR1010 ( Other Identifier: Aragon Pharmaceuticals, Inc. ) 2014-001426-14 ( EudraCT Number ) |
First Posted: | April 28, 2014 Key Record Dates |
Last Update Posted: | February 26, 2021 |
Last Verified: | February 2021 |
Studies a U.S. FDA-regulated Device Product: | No |
Prostatic Neoplasms Metastatic Castration-Resistant Prostate Cancer (mCRPC) Prostate cancer |
Abiraterone Acetate (ZYTIGA) Prednisone JNJ-56021927 |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Prednisone Abiraterone Acetate Anti-Inflammatory Agents Glucocorticoids |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hormone Antagonists Cytochrome P-450 Enzyme Inhibitors |