A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer

Prostatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02123758
• Other study ID #: CR104358
• Secondary ID: 56021927PCR10102
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 9, 2014
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Aragon Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. It will also, potentially provide dosing recommendations for abiraterone acetate in future studies when combined with JNJ-56021927.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 57
• Est. completion date: December 31, 2024
• Est. primary completion date: June 27, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Castration-Resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

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).
• 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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aragon Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)
Primary	Maximum plasma concentration (Cmax) of abiraterone, prednisone and its metabolite prednisolone	The Cmax is the maximum observed plasma concentration.	Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)
Primary	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.	Day 7 (Treatment Cycle 1) and on Day 36 (Treatment Cycle 2)
Secondary	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.	Day 36 (Treatment Cycle 2), on Day 57 (Treatment Cycle 3)
Secondary	Maximum plasma concentration (Cmax) of JNJ-56021927 and its metabolite JNJ-56142060	The Cmax is the maximum observed plasma concentration.	Day 36 (Treatment Cycle 2), on Day 57 (Treatment Cycle 3)
Secondary	Change in prostate specific antigen (PSA)	Prostate-specific antigen (PSA) is a protein produced by cells of the prostate gland.	Up to the end of the treatment phase (approximately 18 months)
Secondary	Maximal decline in prostate specific antigen (PSA)	Prostate-specific antigen (PSA) is a protein produced by cells of the prostate gland.	Up to the end of the treatment phase (approximately 18 months)