Prostatic Neoplasms
Conditions
Brief summary
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.
Interventions
DRUGJNJ-101556143
Participants will receive JNJ-101556143 orally.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have histologically confirmed adenocarcinoma of the prostate. Primary (or pathologic evidence of conversion to) small cell carcinoma, carcinoid tumor, mixed neuroendocrine carcinoma, large cell neuroendocrine carcinoma, or sarcoma of the prostate is disallowed * Progressive metastatic androgen pathway modulation-resistant prostate cancer (mAPMR) defined as having a Prostate-Specific Antigen (PSA) level greater than or equal (\>=) 10 nanograms per milliliter (ng/mL) and at least one of the following: (a) PSA progression defined as at least 2 consecutive increases in PSA value over a previous reference value measured at least 1 week apart. (b) Progressive disease or new lesion(s) in the lymph nodes, bones, or viscera on conventional imaging (computed tomography \[CT\]/magnetic resonance imaging \[MRI\]) as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) and/or on bone scan per Prostate Cancer Working Group 4 (PCWG4) while on Androgen Deprivation Therapy (ADT) (either surgically \[bilateral orchiectomy\] or with medication). Local-regional disease including invasive disease of rectum, bladder, pelvis is allowed as long as participant has a current or past history of distant metastasis (M1 disease). Participants in Part 1 must have measurable disease per RECIST v1.1 by conventional imaging with CT or MRI (chest, abdomen, and pelvis) and/or Technetium-99\^m (99\^mTc) bone scan confirmed by Blinded Independent Central Review (BICR) at the time of screening * Prior bilateral orchiectomy or medical castration (receiving ongoing ADT with a Gonadotropin-Releasing Hormone (GnRH) analog \[agonist or antagonist\]) with castrate level of serum testosterone (less than \[\<\] 50 nanograms per deciliter \[ng/dL\] or 1.7 nanomoles per liter \[nmol/L\]) prior to the first dose of trial intervention and must continue this therapy throughout the treatment phase * Have discontinued concurrent use of any non-investigational systemic anticancer therapy (that is, cytotoxic chemotherapy, Androgen Receptor Pathway Inhibitor (ARPI), radiation therapy) within 2 weeks or Lutetium-177 Prostate-Specific Membrane Antigen-617 (177\^Lu PSMA-617) within 6 weeks prior to first dose of trial intervention, or any investigational drugs within 3 months of first dose of trial intervention * Toxicity related to prior anticancer treatment that is deemed clinically relevant must have resolved to common terminology criteria for adverse events (CTCAE) Version 6.0 Grade 1 or better
Exclusion criteria
* Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of patients with Gilbert's Syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment) * Suspected or known allergies, hypersensitivity, or intolerance to JNJ-101556143 or its excipients * Had major surgery or had significant traumatic injury less than or equal to 28 days of the first dose of trial intervention. Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate * Spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days * Solid organ or bone marrow transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Up to 2 years and 8 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DoR) | Up to 2 years and 8 months | 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. |
| Radiographic Progression-Free Survival (rPFS) | Up to 2 years and 8 months | 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 to Symptomatic Progression (TSP) | Up to 2 years and 8 months | TSP is defined as the time from the first dose of trial intervention until the date of symptomatic progression or death, whichever comes first. |
| Number of Participants with Treatment-Emergent Adverse Event (TEAE) by Severity | Up to 2 years and 8 months | 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. |
| Number of Participants with Abnormalities in Clinical Laboratory Tests | Up to 2 years and 8 months | Number of participants with abnormalities in clinical laboratory tests will be reported. |
| Minimum Plasma Concentration (Cmin) of JNJ-101556143 | 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) | Minimum plasma concentration of JNJ-101556143 will be reported. |
| Maximum Plasma Concentration (Cmax) of JNJ-101556143 | 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 of JNJ-101556143 will be reported. |
| Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24h) of JNJ-101556143 | 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) | 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. |
Countries
China, United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed