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60 Participants NeededMy employer runs this trial

FX-111 for Prostate Cancer

Recruiting at 9 trial locations
JK
CM
Overseen ByCarolyn McCrone, Sr Clinical Trial Associate
Age: 18+
Sex: Male
Trial Phase: Phase 1
Sponsor: Flare Therapeutics Inc.
Must be taking: Androgen deprivation therapy
Must not be taking: Antivirals, Antibiotics, Anti-fungals, others
Disqualifiers: Brain metastases, Active infections, Blood clots, others
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?

The goal of this clinical trial is to find out if FX-111 is safe enough to permit further studies in adult male participants with metastatic castration-resistant prostate cancer (mCRPC). It will also study the drug's pharmacokinetics (how the body breaks down FX-111) and how well FX-111 treats mCRPC. The main questions it aims to answer are:

What are the side effects of FX-111?

Does FX-111 work to reduce or prevent progression of mCRPC?

The study doctor will oversee participants' treatment with FX-111 and ask about any side effects. Participants will take FX-111 every day by mouth and will have regular physical and laboratory examinations to check health and tumor status.

Are You a Good Fit for This Trial?

This trial is for adult men with metastatic castration-resistant prostate cancer whose disease has progressed despite hormone therapy and at least one other advanced prostate cancer drug. Participants must have rising PSA levels, be in generally good health, and agree to use effective birth control.

Inclusion Criteria

PSA levels ≥ 2 ng/mL at screening visit
Progressing PSA defined as two consecutive increases in the most recent PSA measurements taken at least 1 week apart
I have been diagnosed with prostate adenocarcinoma.
See 6 more

Exclusion Criteria

My prostate cancer is mainly small cell or neuroendocrine type.
I have not had a blood clot in the last 4 weeks.
I do not have another active cancer needing treatment, or any recent cancer in the past 2 years.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FX-111 daily by mouth with regular physical and laboratory examinations to check health and tumor status

6 months
Regular visits for physical and laboratory examinations

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks
Tumor assessments every 8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • FX-111

Trial Overview

The study tests a new oral drug called FX-111 taken daily to see if it is safe and how well it works against advanced prostate cancer that no longer responds to standard hormone treatments. Doctors will monitor side effects and tumor response closely.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Group I: FX-111 Dose Level 5Experimental Treatment1 Intervention
Group II: FX-111 Dose Level 4Experimental Treatment1 Intervention
Group III: FX-111 Dose Level 3Experimental Treatment1 Intervention
Group IV: FX-111 Dose Level 2Experimental Treatment1 Intervention
Group V: FX-111 Dose Level 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Flare Therapeutics Inc.

Lead Sponsor

Trials
1
Recruited
80+

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