Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2026-01-31 @ 5:45 AM
Study NCT ID:
NCT03709550
Status:
WITHDRAWN
Last Update Posted:
2022-10-05
First Post:
2018-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enzalutamide and Decitabine in Treating Patients With Metastatic Castration Resistant Prostate Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
Official Title:
Phase Ib/II Study of Enzalutamide With Decitabine, a DNA Hypomethylating Agent, in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Status:
WITHDRAWN
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I/II trial studies the side effects and best dose of decitabine and how well it works when given together with enzalutamide in treating patients with castration resistant prostate cancer that has spread to other places in the body. Androgen can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, may lessen the amount of androgen made by the body. Decitabine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving decitabine and enzalutamide may work better in treating participants with castration resistant prostate cancer.
Detailed Description:
PRIMARY OBJECTIVES I. To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of decitabine in combination with enzalutamide in patients with refractory metastatic castrate resistant prostate cancer (mCRPC). (Phase 1b) II. To determine the 12-month progression free survival rate of patients with enzalutamide-naive metastatic castrate resistant prostate cancer (mCRPC) treated with decitabine plus enzalutamide. (Phase 2)
SECONDARY OBJECTIVES:
I. To determine the safety and tolerability of decitabine in combination with enzalutamide in patients with refractory metastatic castrate resistant prostate cancer (mCRPC). (Phase 1b) II. To determine the overall response rate, overall survival and prostate specific antigen (PSA) changes in enzalutamide-naive mCRPC patients treated with decitabine plus enzalutamide. (Phase 2) III. To determine the safety and tolerability of decitabine in combination with enzalutamide in the study population. (Phase 2)
EXPLORATORY OBJECTIVES:
I. To determine the relationship between decitabine dose and plasma biomarkers (e.g., levels of HbF, LINE-1 methylation, number of circulating tumor cell's \[CTC?s\] and, NY-ESO expression in CTC?s). (Phase 1b) II. To explore plasma and tumor immune biomarkers associated with efficacy to the study combination. (Phase 2) III. To determine if treatment emergent neuroendocrine transformation is present as a result of the treatment combination of enzalutamide plus decitabine. (Phase 2) IV. Evaluate changes in stem cell reprogramming factors and deoxyribonucleic acid (DNA)/ribonucleic acid (RNA) markers resulting from the treatment combination. (Phase 2)
OUTLINE: This is a phase Ib, dose-escalation study of decitabine followed by a phase II study.
Participants receive decitabine intravenously (IV) over 1 hour on days 1-5 and enzalutamide orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up every 3 months for 24 months.
SECONDARY OBJECTIVES:
I. To determine the safety and tolerability of decitabine in combination with enzalutamide in patients with refractory metastatic castrate resistant prostate cancer (mCRPC). (Phase 1b) II. To determine the overall response rate, overall survival and prostate specific antigen (PSA) changes in enzalutamide-naive mCRPC patients treated with decitabine plus enzalutamide. (Phase 2) III. To determine the safety and tolerability of decitabine in combination with enzalutamide in the study population. (Phase 2)
EXPLORATORY OBJECTIVES:
I. To determine the relationship between decitabine dose and plasma biomarkers (e.g., levels of HbF, LINE-1 methylation, number of circulating tumor cell's \[CTC?s\] and, NY-ESO expression in CTC?s). (Phase 1b) II. To explore plasma and tumor immune biomarkers associated with efficacy to the study combination. (Phase 2) III. To determine if treatment emergent neuroendocrine transformation is present as a result of the treatment combination of enzalutamide plus decitabine. (Phase 2) IV. Evaluate changes in stem cell reprogramming factors and deoxyribonucleic acid (DNA)/ribonucleic acid (RNA) markers resulting from the treatment combination. (Phase 2)
OUTLINE: This is a phase Ib, dose-escalation study of decitabine followed by a phase II study.
Participants receive decitabine intravenously (IV) over 1 hour on days 1-5 and enzalutamide orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up every 3 months for 24 months.
Study Oversight
Has Oversight DMC:
True
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?:
True
Is an FDA AA801 Violation?: