8 Participants Needed

Decitabine + Cedazuridine + Enzalutamide for Prostate Cancer

Age: 18+
Sex: Male
Trial Phase: Phase 1
Sponsor: Roswell Park Cancer Institute
Must be taking: Enzalutamide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Gurkamal Chatta MD | Roswell Park ...

Gurkamal Chatta, Dr.

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

Men over 18 with metastatic castrate resistant prostate cancer, showing disease progression. They must have good performance status (able to carry out daily activities), low testosterone levels if not on androgen deprivation therapy, adequate organ function, and the ability to swallow pills. Prior treatments for prostate cancer are allowed in some phases of the trial. Participants must use contraception.

Inclusion Criteria

I can swallow and keep down pills.
I am fully active or can carry out light work.
Understanding and signing an informed consent form
See 5 more

Exclusion Criteria

I haven't had another cancer within the last 3 years.
Unsuitable candidate to receive study drug
I am taking certain medications that I cannot stop.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive decitabine and cedazuridine orally once daily on either days 1-3, 1-4, or 1-5 and enzalutamide orally once daily on days 1-28. Treatments repeat every 28 days for up to 6 cycles.

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

24 months
Follow-up at 30 days, then every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Decitabine and Cedazuridine
  • Enzalutamide
Trial Overview The trial is testing the combination of decitabine/cedazuridine with enzalutamide to determine safe dosages and potential benefits or side effects in treating advanced prostate cancer that resists standard treatment. The goal is also to see if this combo can overcome resistance developed against enzalutamide alone.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (decitabine and cedazuridine, enzalutamide)Experimental Treatment2 Interventions

Decitabine and Cedazuridine is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Inaqovi for:
🇺🇸
Approved in United States as ASTX727 for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials
427
Recruited
40,500+

National Comprehensive Cancer Network

Collaborator

Trials
121
Recruited
7,400+
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