Prostatic Neoplasms, Castration-Resistant Clinical Trial
Official title:
A Phase 1 Study of Androgen Receptor (AR) Antagonist JNJ-56021927 in Subjects With Metastatic Castration-Resistant Prostate Cancer
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04104776 -
A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT03325127 -
Outcomes of mCRPC Patients Treated With Ra-223 Concomitant With Abiraterone or Enzalutamide- A Chart Review Study
|
||
| Withdrawn |
NCT02906605 -
A Study of the Clinical Activity and Safety of JNJ-64041809, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Apalutamide Versus Apalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT05743621 -
Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer
|
Phase 1 | |
| Completed |
NCT02204072 -
BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC)
|
Phase 1 | |
| Recruiting |
NCT05393791 -
Phase II Randomised Controlled Trial of Patient-specific Adaptive vs. Continuous Abiraterone or eNZalutamide in mCRPC
|
Phase 2 | |
| Completed |
NCT03927391 -
Effect of a Reduced Dose Enzalutamide in Frail (m)CRPC Patients on Cognitive Side Effects
|
Phase 4 | |
| Completed |
NCT02450812 -
Non-interventional Study With Ra-223 Dichloride Assessing Overall Survival and Effectiveness Predictors for mCRPC Patients in a Real Life Setting in Germany
|
||
| Recruiting |
NCT06353386 -
Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03431350 -
A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03822845 -
Evaluating the Clinical Accuracy of Gallium-68 PSMA PET/CT Imaging in Patients With Biochemical Recurrence of Prostate Cancer
|
Phase 2/Phase 3 | |
| Completed |
NCT02899104 -
Navigant Study- Treatment Patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer )
|
||
| Active, not recruiting |
NCT04381832 -
Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT03563014 -
A Local Retrospective Observational Study to Evaluate the Treatment Patterns of mCRPC Patients in Belgium Treated With Radium-223
|
||
| Active, not recruiting |
NCT05968599 -
A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer
|
||
| Active, not recruiting |
NCT02803437 -
Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases
|
||
| Recruiting |
NCT05944237 -
HTL0039732 in Participants With Advanced Solid Tumours
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT03173859 -
Efficacy of Rotations Between Abiraterone Acetate and Apalutamide in mCRPC Patients
|
Phase 2 | |
| Terminated |
NCT02057666 -
Study Of Tasquinimod In Asian Chemo-Naïve Patients With Metastatic Castrate-Resistant Prostate Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT04717154 -
Ipilimumab With Nivolumab for Molecular-selected Patients With Castration-resistant Prostate Cancer
|
Phase 2 |