A Safety Study of JNJ-56021927 in Participants With Metastatic Castration-Resistant Prostate Cancer

Janssen Pharmaceutical K.K.6 enrolled

Overview

The purpose of this study is to evaluate the safety and tolerability of JNJ-56021927 in Japanese participants with metastatic castration-resistant prostate cancer (mCRPC- prostate cancer that is resistant to medical \[for example. hormonal\] or surgical treatments).

This is a Phase 1, multicenter, open-label (participants will know the identity of study drug received) study in participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC). The study consists of 4 parts: Screening (28 days before study commences on Day 1), pharmacokinetic week (PK), Continuous daily dosing, Extension and Safety follow-up period. In PK week participants will receive a single oral capsule of JNJ-56021927 at a dose of 240 milligram (mg) on Day 1 and will be monitored for 1 week. After Week 1, in continuous daily dosing period, participants will receive continuous daily therapy at the same dose for 4 weeks (Cycle 1). After Cycle 1 participants, who will not meet the criteria for discontinuation listed such as progressive disease (PD) or unacceptable toxicity, will continue in safety follow-up period and will receive continuous daily therapy at the same dose up to cycle 13. Primarily dose limiting toxicity (DLT) will be evaluated. Participants' safety will be monitored throughout.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostatic Neoplasms, Castration-Resistant

Interventions

JNJ-56021927DRUG

Participants will receive 8 capsules of JNJ-56021927, 240 milligram (mg) as single oral dose on Day 1. After participants will receive daily JNJ-56021927, 240 mg on Day 1 of Cycle 1 until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first.

Eligibility

Sex: MALEMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features, with metastatic disease * Castration-resistant prostate cancer (CRPC) demonstrated during continuous androgen deprivation therapy (ADT)/post orchiectomy * Maintain castrate levels of testosterone (less than \[\<\] 50 nanogram per deciliter (ng/dL) \[1.72 nanomol per liter {nmol/L}\]) within 4 weeks before enrollment * Prostate-specific antigen (PSA) evidence for progressive prostate cancer consists of a PSA level of at least greater than or equal to (\>=) 2 nanogram per milliliter (ng/mL) within 2 weeks before enrollment which has risen on at least 2 successive occasions, at least 1 week apart. If the confirmatory PSA value is less than the last PSA value, then an additional test for rising PSA will be required to document progression * Participants who received a first generation anti-androgen \[for example, bicalutamide, flutamide, nilutamide (not approved in Japan)\] as part of an initial combined androgen blockade therapy or as second-line hormonal therapy must show continuing disease progression off the anti-androgen for at least 4 weeks prior to the first dose of study drug Exclusion Criteria: * History of, or current metastases in the brain or untreated spinal cord compression * Participants with progressive epidural disease * Participants has a history of another malignancy within 5 years before screening * Prior treatment with second generation anti-androgens ( for example, enzalutamide) or Cytochrome P450 17 (CYP 17) inhibitors \[for example, abiraterone acetate, orteronel, galeterone, systemic ketoconazole (not approved in Japan, respectively)\] * Participants had used radiopharmaceutical agents (for example, Strontium-89) or investigational immunotherapy (for example, sipuleucel-T) within 12 weeks before the first dose of study drug

Locations (4)

Unnamed facility

Fukuoka, Japan

Unnamed facility

Gifu, Japan

Unnamed facility

Matsuyama, Japan

Unnamed facility

Yokohama, Japan

Outcomes

Primary Outcomes

Number of Participants With Dose Limiting Toxicity

The dose will be considered intolerable if a participants developed either any Grade 3 or 4 non-hematologic toxicity; GI toxicities such as abdominal pain, nausea, vomiting, constipation, and diarrhea, must persist at Grade 3-4 despite maximal medical therapy, Grade 4 neutropenia (that is, ANC less than \[\<\] 500 per microliter \[mcL\] for five or more consecutive days, Grade 4 thrombocytopenia (\<25,000 per mcL) or Grade 3 thrombocytopenia (greater than or equal to \[\>=\] 25,000 - \<50,000 per mcL) with a bleeding episode requiring platelet transfusion, any other Grade 4 hematologic toxicity of more than 5 days duration, any grade treatment-related seizure, the other toxicities which do not meet any of the above criteria but which, in the opinion of the Investigator, are equivalent to DLTs.

Time frame: Week 1 up to Day 28 of Cycle 1

Secondary Outcomes

Maximum Observed Plasma Concentration (C[max])

The C(max) is the maximum plasma concentration which will be observed at the defined time points.

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 and 96 hours post administration of study drug

Time to Reach the Maximum Plasma Concentration (T[max])

The T\[max\] is time to reach the observed maximum plasma concentration.

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 and 96 hours post administration of study drug

Elimination Half-life (t1/2[lambda])

Elimination half-life associated with the terminal slope (lambda\[z\]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda (z).

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 and 96 hours post administration of study drug

Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours

The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.

Data from ClinicalTrials.gov

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