Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-56021927 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
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 ...
JNJ-56021927 is an investigational small molecule being studied for the treatment of metastatic castration-resistant prostate cancer, a form of prostate cancer that progresses despite androgen deprivation therapy. It is currently in clinical development and has not been approved by regulatory authorities.
JNJ-56021927 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is an investigational oncology therapy in early-stage clinical development.
JNJ-56021927 is in Phase 1 clinical development. A Phase 1 safety study of the drug has been completed, and it remains an investigational agent that has not received regulatory approval. Further clinical trials would be needed to establish its safety and efficacy.
JNJ-56021927 has one completed clinical trial, NCT02162836, a Phase 1 safety study in participants with metastatic castration-resistant prostate cancer. The study enrolled 6 male participants aged 20 years and older in Japan and was not randomized or blinded.
JNJ-56021927 is an investigational drug being developed by Johnson & Johnson for metastatic castration-resistant prostate cancer. The available information does not indicate that JNJ-56021927 is the same as apalutamide, which is a different marketed product.