A Phase 1 interventional study of JNJ-56021927 in Prostatic Neoplasms, Castration-Resistant, sponsored by Janssen Pharmaceutical K.K.. Completed at 4 sites in Japan. Open to male participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-04-27.
Sponsored by Janssen Pharmaceutical K.K. · Phase 1, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 6 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Janssen Pharmaceutical K.K. is the lead sponsor of 122 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 6 (50%) have results posted.
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Exclusion Criteria:
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
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.
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
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.
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 Infinite Time (AUC [0-last])
The AUC (0-last) is the area under the plasma concentration-time curve from time zero time of the last quantifiable concentration C(last), and C(last) is the last observed quantifiable 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
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z), wherein AUC(0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
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
Change in Prostate-specific Antigen (PSA)
Change in prostate specific antigen will be assessed using the Prostate Cancer Working Group 2 (PCWG2) criteria and Response Criteria in Solid Tumors (RECIST). PSA progression will delayed if decline from baseline: greater than or equal to (\>=) 25 percent (%) and \>= 2 nanogram per milliliter (ng/mL) above the PSA nadir, which is confirmed by a second value 3 or more weeks later; and no decline from baseline: PSA progression \>= 25% and \>= 2 ng/mL after 12 weeks.
Time frame: Baseline, Day 1 of each cycle (28 days) until disease progression and up to 28 days after the last dose study drug
Trough Plasma Concentration (C[trough])
Trough plasma concentration (C\[trough\]) just before dosing will be assessed.
Time frame: Pre- dose on Day 1 of Cycle 2 up to Cycle 13
Observed Accumulation Index (A[cc] Index)
Observed Accumulation Index (A\[cc\] Index) will be calculated as AUC\[0-24\] at steady state divided by AUC\[0-24\].
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 in Cycle 1
Effective Half-life (EHL)
Effective Half-life (EHL) will be calculated as dosing interval minus log 2 divided by log {1-\[1/A\[cc\]Index}.
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 in Cycle 1
Percent Peak to Trough Fluctuation (PTF)
Percent Peak to Trough Fluctuation (PTF) will be calculated as 100 multiplied by {C\[max\]/C\[min\]}.
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 in Cycle 1
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Janssen Pharmaceutical K.K.