The purpose of this study is to evaluate how well JNJ-101556143 works in participants with metastatic androgen pathway modulation-resistant prostate cancer (mAPMR), an advanced form of prostate cancer that has spread and no longer responds to hormone therapy. The study will measure the overall response (tumor shrinkage or disappearance) following treatment with JNJ-101556143.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Participants will receive JNJ-101556143 orally.
Overall Response Rate (ORR)
Confirmed overall response, is defined as having either confirmed complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR) prior to any subsequent anti-cancer therapy.
Time frame: Up to 2 years and 8 months
Duration of Response (DoR)
DoR is defined as the time from the date of first documented response for a confirmed radiographic response (CR or PR) per RECIST v1.1 until the date of documented radiographic progression by BICR, or death, whichever comes first.
Time frame: Up to 2 years and 8 months
Radiographic Progression-Free Survival (rPFS)
rPFS is defined as the time from the date of initiation of therapy until the date of radiographic disease progression or death, whichever comes first.
Time frame: Up to 2 years and 8 months
Time to Symptomatic Progression (TSP)
TSP is defined as the time from the first dose of trial intervention until the date of symptomatic progression or death, whichever comes first.
Time frame: Up to 2 years and 8 months
Number of Participants with Treatment-Emergent Adverse Event (TEAE) by Severity
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale defined as Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
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Time frame: Up to 2 years and 8 months
Number of Participants with Abnormalities in Clinical Laboratory Tests
Number of participants with abnormalities in clinical laboratory tests will be reported.
Time frame: Up to 2 years and 8 months
Minimum Plasma Concentration (Cmin) of JNJ-101556143
Minimum plasma concentration of JNJ-101556143 will be reported.
Time frame: Pre-dose (0 hours); 2 to 3 hours post dose from Cycle 1 to Cycle 2 and 4 to 8 hours post dose from Cycle 1 to Cycle 2 (Each Cycle Duration= 28 days)
Maximum Plasma Concentration (Cmax) of JNJ-101556143
Maximum plasma concentration of JNJ-101556143 will be reported.
Time frame: Pre-dose (0 hours); 2 to 3 hours post dose from Cycle 1 to Cycle 2 and 4 to 8 hours post dose from Cycle 1 to Cycle 2 (Each Cycle Duration= 28 days)
Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24h) of JNJ-101556143
AUC0-24h is the area under the plasma concentration-time curve from the time of JNJ-101556143 dose administration up to 24-hour dosing interval.
Time frame: Pre-dose (0 hours); 2 to 3 hours post dose from Cycle 1 to Cycle 2 and 4 to 8 hours post dose from Cycle 1 to Cycle 2 (Each Cycle Duration= 28 days)