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

NCT02162836 | Completed Phase 1

• 2 other identifiers: CR10365356021927PCR1008
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

Prostatic Neoplasms, Castration-Resistant

Keywords

Prostatic Neoplasms, Castration-Resistant; Metastatic Castration-Resistant Prostate Cancer; Prostate Cancer; Androgen Receptor; JNJ-56021927

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 1 up to Day 28 of Cycle 1

Secondary Outcomes (11)

• Maximum Observed Plasma Concentration (C[max])

  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])

  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])

  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

  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 Infinite Time (AUC [0-last])

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

Study Arms (1)

Cohort 1

EXPERIMENTAL

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.

Drug: JNJ-56021927

Interventions

JNJ-56021927 DRUG

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.

Cohort 1

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (4)

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Gifu, Japan

Location

Unknown Facility

Matsuyama, Japan

Location

Unknown Facility

Yokohama, Japan

Location

Related Publications (2)

• Tsuchiya T, Imanaka K, Iwaki Y, Oyama R, Hashine K, Yamaguchi A, Uemura H. An open-label, phase 1 study of androgen receptor antagonist, apalutamide in Japanese patients with metastatic castration-resistant prostate cancer. Int J Clin Oncol. 2019 Dec;24(12):1596-1604. doi: 10.1007/s10147-019-01526-7. Epub 2019 Aug 24.

  PMID: 31446511 RESULT

• Uemura H, Koroki Y, Iwaki Y, Imanaka K, Kambara T, Lopez-Gitlitz A, Smith A, Uemura H. Skin rash following Administration of Apalutamide in Japanese patients with Advanced Prostate Cancer: an integrated analysis of the phase 3 SPARTAN and TITAN studies and a phase 1 open-label study. BMC Urol. 2020 Sep 2;20(1):139. doi: 10.1186/s12894-020-00689-0.

  PMID: 32878613 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant; Prostatic Neoplasms; Bulbo-Spinal Atrophy, X-Linked

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Muscular Atrophy, Spinal; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Motor Neuron Disease; Neuromuscular Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trials

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 13, 2014
• Study Start: June 27, 2014
• Primary Completion: May 27, 2019
• Study Completion: May 27, 2019
• Last Updated: April 27, 2020

Record last verified: 2020-04

Locations

JP (4)