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Clinical Trial Summary

This phase Ib trial is to find out the best dose decitabine/cedazuridine and possible benefits and/or side effects of decitabine/cedazuridine and enzalutamide in treating patients with castrate resistant prostate cancer that has spread to other places in the body (metastatic). Chemotherapy drugs, such as decitabine/cedazuridine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Enzalutamide blocks the use of androgen by the tumor cells. Giving decitabine/cedazuridine together with enzalutamide may reverse or help prevent the acquired therapeutic resistance that is observed when enzalutamide is used alone. Drug resistance occurs when cancer cells stop responding to a chemotherapy that had previously been effective.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To determine the safety of oral decitabine and cedazuridine (decitabine/cedazuridine) in combination with enzalutamide in patients with metastatic castrate resistant prostate cancer (mCRPC). SECONDARY OBJECTIVE: I. To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of oral decitabine/cedazuridine in combination with enzalutamide in patients with metastatic castrate resistant prostate cancer (mCRPC). EXPLORATORY OBJECTIVES: I. To determine the relationship between decitabine/cedazuridine dose and plasma biomarkers such as HbF and LINE-1 methylation. II. Analyze circulating tumor deoxyribonucleic acid (DNA) by whole exome sequencing and DNA methylation analysis to monitor effects of treatment and emergence of ARlow CRPC/NEPC. III. Measure for achievement of the intended molecular PD-effects of DNMT1-depletion, i.e., LINE-1 demethylation in tumor tissue. IV. Assess effects of treatment on tumor cell DNA methylation using Infinium Methylation EPIC Arrays where suitable tissue is accessible. V. To evaluate drug exposure to decitabine/cedazuridine by pharmacokinetic sampling on day 3, day 4, or day 5 (Cohorts -1, 1, 2) of cycle 1. OUTLINE: This is a dose-escalation study of decitabine and cedazuridine. Patients receive decitabine and cedazuridine orally (PO) once daily (QD) on either days 1-3, 1-4, or 1-5 and enzalutamide PO QD on days 1-28. Treatments repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, then every 3 months for 24 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05037500
Study type Interventional
Source Roswell Park Cancer Institute
Contact
Status Not yet recruiting
Phase Phase 1
Start date October 1, 2021
Completion date October 1, 2025

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