Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312670
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-02-16
Brief Title:
Combining EPI-7386 with Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer
Sponsor:
Pedro Barata MD MSc
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase 2 Trial Combining EPI-7386 with Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to study the effects of EPI-7386 in combination with Enzalutamide on participants diagnosed with prostate cancer The main goals of this study are to evaluate the antitumor activity of EPI-7386 in combination with enzalutamide in metastatic hormone-sensitive prostate cancer mHSPC and to evaluate the pharmacokinetics PK of EPI-7386 when dosed in combination with enzalutamide Participants will will take the study drug EPI-7360 twice a day by mouth and enzalutamide once a day by mouth alongside clinic visits every two weeks
Detailed Description:
EPI-7386 is an investigational drug that works by blocking the androgen receptor at a different site compared to the approved androgen receptor blockers This may increase the effectiveness of this drug and increase the effectiveness of approved androgen receptor blockers when taken together EPI-7386 is a new drug therefore its effectiveness and safety in prostate cancer patients must be studied before it is approved by the Food and Drug Administration EPI-7386 is experimental because it is not currently approved by the Food and Drug Administration FDA Enzalutamide is approved by the FDA for patients whose prostate cancers has spread after receiving treatment The hypothesis is that adding EPI-7386 to standard hormone therapy will be more effective in treating cancer compared to usual treatment with the long term goal of discovering more about hormone therapy as a treatment for cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None