Castrate Resistant Prostate Cancer Clinical Trial
Official title:
Phase I/II, Multi-center, Open Label, Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti Tumor Activity of ASP9521 in Patients With Metastatic Castrate-resistant Prostate Cancer
The study has three parts. Part 1 is a dose escalation to investigate the safety and tolerability of ASP9521. Part 2 will evaluate the safety and tolerability and initial anti-tumor activity of ASP9521. Part 3 of the study will be a Food Effect study.
The purpose of the first study part is to investigate the safety and tolerability of ASP9521
in patients with Castrate Resistant Prostate Cancer. This will be done at different doses,
starting at the lowest dose up to higher doses to find the maximum dose that is tolerated.
The second part will investigate the safety and tolerability and evaluate initial anti-tumor
activity of ASP9521. This will be done at multiple doses which are identified in part 1 to
potentially be effective. The number of patients in part 2 will be higher number compared to
part I.
The third part of the study will investigate the effect of food on the drug in patients;
this will be a crossover design fed to fasted and vice versa.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05415098 -
Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
| Withdrawn |
NCT05191017 -
Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT04296578 -
Study Evaluating Sodium Selenite in Combination With Abiraterone in Castrate Resistant Prostate Cancer Progressing on Abiraterone
|
Phase 1 | |
| Recruiting |
NCT05655715 -
Checkpoint Inhibitors and SBRT for mCRPC
|
Phase 2 | |
| Recruiting |
NCT06395519 -
A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies
|
Phase 1 | |
| Completed |
NCT01144897 -
PET Acetate for Castrate-Resistant Prostate Cancer on Chemotherapy
|
Phase 1 | |
| Recruiting |
NCT05252390 -
NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04969315 -
TT-10 as a Single Agent in Subjects With Advanced Selected Solid Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT01313559 -
Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chemotherapy Naive Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT04319783 -
Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA
|
Phase 2 | |
| Recruiting |
NCT05627752 -
Docetaxel Alone or in Combination With Enzalutamide for mCRPC Previously Treated With Abiraterone at mHSPC Stage
|
Phase 2/Phase 3 | |
| Terminated |
NCT04737109 -
Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer
|
Phase 1/Phase 2 | |
| Terminated |
NCT01907009 -
A Phase II Study Evaluating Intravenous Melphalan With Autologous Whole Blood Stem Cell Transplantation Over Three Cycles In Patients With Castration-Resistant Prostate Cancer (MEL-CAP)
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05570994 -
177Lu-HTK03170 in mCRPC With PSMA Positive Disease
|
Phase 1/Phase 2 | |
| Completed |
NCT05159518 -
A Study of PRT2527 in Participants With Advanced Solid Tumors
|
Phase 1 | |
| Terminated |
NCT04541225 -
Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05488548 -
Dual BET and CBP/p300 Inhibitor in Patients With Targeted Advanced Solid Tumors
|
Phase 1 | |
| Withdrawn |
NCT05156372 -
Adjuvant High-intensity Interval Training During Chemotherapy in Metastatic Prostate Cancer Patients
|
N/A | |
| Recruiting |
NCT05766371 -
Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT04335682 -
Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide
|
Phase 2 |