A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic Castration-Resistant Prostate Cancer

A Phase 1 Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Subjects With Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to evaluate pharmacokinetics (PK) following a single dose and multiple dose treatment and the safety of apalutamide in Chinese participants with metastatic castration resistant prostate cancer (mCRPC) at dose of 240 milligram (mg).

Study Overview

• Status: Active, not recruiting
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Drug: Apalutamide

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100083
    • Peking University Third Hospital
  • Beijing, China, 100142
    • Beijing Cancer Hospital of Peking University
  • NanJing, China, 210000
    • Jiangsu Cancer Hospital
  • ShangHai, China, 200032
    • Fudan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2
• Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
• Metastatic disease as documented by bone scan or metastatic lesions by computed tomography or magnetic resonance imaging scans (visceral or lymph node disease). Lymph nodes in the pelvis must measure at least 1.5 centimeter in a short axis to be considered target lesion according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on the Prostate Cancer Working Group 2 (PCWG2) criteria
• Castration-resistant prostate cancer (PC) demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of prostate-specific antigen (PSA), at least 1 week apart, with the last PSA greater than or equal to (>=) 2 nanogram per milliliter (ng/mL)
• Prior hormonal interventions (including 1st generation antiandrogens [flutamide, bicalutamide, nilutamide], steroids, estrogens, finasteride, dutasteride) for PC are allowed. These therapies, except for gonadotropin releasing hormone analogs (GnRH) analogs and prednisone/prednisolone, must have been discontinued for minimally 4 weeks (2 weeks only for flutamide, nilutamide, or finasteride) before first dose of study drug

Exclusion Criteria:

• Known brain metastases
• Chemotherapy, or immunotherapy within 2 weeks or 5 half-lives of the drug prior to the first dose of study drug, whichever is longer, with a maximum of 4 weeks.
• Prior treatment with second-generation anti-androgens (example [eg], enzalutamide)
• Administration of an investigational therapeutic within 2 weeks or 5 half-lives of the drug prior to the first dose of study drug, whichever is longer, with a maximum of 4 weeks. And participant use radiopharmaceutical agents (eg, strontium-89) or investigational immunotherapy (eg, sipuleucel-T) within 12 weeks prior to the first dose of study drug
• Prior treatment with cytochrome 17 inhibitors (eg, abiraterone acetate, orteronel, galeterone, systemic ketoconazole)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Apalutamide; Participants will receive a single oral dose of apalutamide 240 milligram (mg) during pharmacokinetics (PK) Week Day 1 and will be monitored for one week (that is; PK Week) to assess PK and safety of drug. Subsequently, participants will further receive daily treatment of apalutamide from Cycle 1 Day 1 onwards until disease progression, withdrawal of consent, lost to follow-up, or the occurrence of unacceptable toxicity. Each treatment cycle consists of 28 days. After final analysis (FA), participants who are receiving apalutamide in the open-label treatment phase may continue receiving single oral dose apalutamide 240 mg once daily in a long-term extension (LTE) phase if they continue to derive benefit from treatment (based on investigator assessment).

Drug: Apalutamide; The participants will receive apalutamide 240 mg once daily orally.; Other Names: JNJ-56021927

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of Apalutamide	Plasma concentration of apalutamide will be reported.	Predose; postdose up to 168 hours (hrs) (Cycle1 Day 7), Cycle 2 (pre-dose; on Day 1 and 15 of cycle 2) and Cycle 3 (pre-dose; up to 24 hrs post-dose). Each cycle is of 28 days
Number of Participants with Adverse Events	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Up to 30 days of last study treatment (approximately 18 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Serum Prostate Specific Antigen (PSA) at Weeks 4 and 12	Change from baseline in serum PSA levels will be determined.	Baseline, at Weeks 4 and 12 or earlier for those who discontinue therapy (up to approximately 4 months).
Maximal Decline in Prostate Specific Antigen	Maximal decline in PSA levels will be determined.	Up to 30 days of last study treatment (approximately 18 months)

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2018
• Primary Completion (Actual): July 9, 2019
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: May 2, 2018
• First Submitted That Met QC Criteria: May 2, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CR107444; 56021927PCR1013 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes