Prostatic Neoplasm Clinical Trial
Official title:
A Phase 1a/1b, Open-Label Study Evaluating the Safety and Tolerability of EZN-4176, an Androgen Receptor mRNA Antagonist, in Adult Patients With Castration-Resistant Prostate Cancer
This study will evaluate an experimental drug called EZN-4176 to determine the anticancer effects when it is given to patients with an advanced form of prostate cancer called castration-resistant prostate cancer (CRPC). Goals of this phase I study include finding out the dose of EZN-4176 that can be safely given without serious side effects and to determine the amount of EZN-4176 that should be given in future studies.
This study will be conducted in two phases:
- Phase 1a will involve dose escalation to determine the maximum tolerated dose (MTD).
The MTD will be determined on the basis of the results from the safety evaluation.
- Phase 1b will involve cohort expansion at one or more dose levels to determine the
recommended Phase 2 dose. The recommended Phase 2 dose, which may differ from the MTD,
will be determined on the basis of results from safety, activity, and pharmacologic and
correlative studies.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03982095 -
Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
|
||
| Recruiting |
NCT05667636 -
Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP
|
Phase 2 | |
| Terminated |
NCT01996696 -
Prevention of Metabolic Syndrome and Increased Weight Using Metformin Concurrent to Androgen Deprivation Therapy and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate
|
Phase 2 | |
| Completed |
NCT01431391 -
Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
|
Phase 2 | |
| Completed |
NCT03289130 -
Dietary Factors and Racial Disparities in Prostate Cancer Aggressiveness
|
||
| Recruiting |
NCT04462926 -
Evaluation of Diagnostic Accuracy of [68Ga]Ga-PSMA-11 PET/CT in Primary Staging of Intermediate and High Risk Prostatic Cancer in Men Newly Diagnosed
|
N/A | |
| Completed |
NCT00001446 -
A Randomized Phase II Study of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer
|
Phase 2 | |
| Completed |
NCT02729103 -
Treatment Patterns in Metastatic Prostate Cancer
|
N/A | |
| Completed |
NCT00956228 -
Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00126854 -
High Field Magnetic Resonance Spectroscopy Imaging for Follow Up of Prostate Cancer Post Brachytherapy Implantation
|
N/A | |
| Completed |
NCT00247312 -
Pd-103 Dose De-Escalation for Early Stage Prostate Cancer: A Prospective Randomized Trial
|
Phase 3 | |
| Completed |
NCT00174863 -
Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer
|
Phase 2 | |
| Terminated |
NCT04221828 -
Trial of NanoPac Focal Therapy for Prostate Cancer
|
Phase 2 | |
| Completed |
NCT00001266 -
A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma
|
Phase 2 | |
| Active, not recruiting |
NCT03935282 -
Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors
|
N/A | |
| Completed |
NCT03693742 -
MSG Use With 18F-DCFPyL PET/CT Imaging
|
N/A | |
| Recruiting |
NCT06236789 -
Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer
|
||
| Completed |
NCT02966535 -
The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial
|
N/A | |
| Completed |
NCT02977143 -
Positive End-expiratory Pressure-induced Increase in Central Venous Pressure as a Predictor of Fluid Responsiveness in Robot-assisted Laparoscopic Surgery
|
N/A | |
| Completed |
NCT00252460 -
CT/MRI Co-registration Prostate Cancer
|
Phase 1 |