← Back to Search

Anti-tumor antibiotic

Debio 4228 for Prostate Cancer

Phase 2

Recruiting

Research Sponsored by Debiopharm International SA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Participant with histologically confirmed locally advanced/metastatic prostate cancer

Must not have

Indication for androgen deprivation combination therapy

Major surgery within 4 weeks before the start of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand how the drug Debio 4228 moves through and affects the body.

Who is the study for?

This trial is for men with advanced or metastatic prostate cancer who are candidates for ongoing hormone therapy. They should have a life expectancy of at least 6 months, be relatively active (ECOG status 0-2), and have normal organ function. Specific medical criteria must also be met.

What is being tested?

The study is testing Debio 4228 to understand how it's processed in the body (pharmacokinetics) and its effects on the body's biological processes (pharmacodynamics) in patients with advanced prostate cancer.

What are the potential side effects?

While specific side effects of Debio 4228 aren't listed, common ones for similar treatments include fatigue, hot flashes, decreased libido, gastrointestinal issues, and potential impacts on bone density.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am able to get out of my bed or chair and move around.

Select...

My prostate cancer is advanced and has spread beyond the prostate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need hormone therapy for my cancer.

Select...

I have not had major surgery in the last 4 weeks.

Select...

I have had surgery to remove both testicles, adrenal glands, or pituitary gland.

Select...

I have not had cancer in the last 2 years, except for prostate or certain skin cancers.

Select...

I had chemotherapy or cryotherapy for prostate cancer within the last 8 weeks.

Select...

I have heart problems or diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3Experimental Treatment1 Intervention

If any alternative dose is deemed necessary based on preliminary data, participants may be enrolled in Cohort 3 to receive Debio 4228 loading dose IM, on Day 1 followed by a maintenance dose IM, 12 weeks after receiving the loading dose (Day 85).

Group II: Cohort 2: Debio 4228 Dose Level 2Experimental Treatment1 Intervention

Participants will receive a single IM administration of dose level 2 Debio 4228 on Day 1.

Group III: Cohort 1: Debio 4228 Dose Level 1Experimental Treatment1 Intervention

Participants will receive a single intramuscular (IM) administration of dose level 1 Debio 4228 on Day 1.

0 / 8Eligibility criteria met