← Back to Search

Androgen Receptor Antagonist

ODM-208 for Prostate Cancer (CYPIDES Trial)

Phase 1 & 2

Waitlist Available

Led By Karim Fizazi

Research Sponsored by Orion Corporation, Orion Pharma

Eligibility Criteria Checklist

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

Must have

Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy

Metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within first 28 days of treatment

Awards & highlights

CYPIDES Trial Summary

This trial will test a new drug, ODM-208, on patients with prostate cancer that has spread and is resistant to hormone therapy. The goal is to see if it is safe and well-tolerated.

Who is the study for?

This trial is for men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread. They should have tried at least one hormonal treatment like abiraterone or enzalutamide, and possibly chemotherapy. Good physical condition (ECOG 0-1) is required, along with normal organ function. Men must be on hormone-lowering treatments or had surgery to remove testicles.Check my eligibility

What is being tested?

The study tests ODM-208, a new drug for advanced prostate cancer that doesn't respond to standard hormone treatments anymore. It looks at how safe the drug is and how it moves through the body when taken by mouth. Some patients will also receive Midazolam as part of the study.See study design

What are the potential side effects?

While specific side effects of ODM-208 are not listed here, common ones in cancer trials include nausea, fatigue, allergic reactions, liver problems, blood clots or changes in heart rhythm which could be monitored during this safety-focused trial.

CYPIDES Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am currently on hormone therapy for cancer or have had both testicles removed.

Select...

My cancer has spread to other parts of my body.

Select...

My prostate cancer is not responding to hormone therapy and my testosterone levels are low.

Select...

I am fully active or can carry out light work.

Select...

My prostate cancer was confirmed through a tissue examination.

Select...

I am a man aged 18 or older.

Select...

My blood test confirmed a specific genetic change in my cancer.

Select...

I have had chemotherapy before or cannot have it due to health reasons.

Select...

I have been treated with hormone therapy for cancer.

Select...

I can swallow pills.

CYPIDES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within first 28 days of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within first 28 days of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within first 28 days of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose (MTD)

CYPIDES Trial Design

3Treatment groups

Experimental Treatment

Group I: ODM-208 Part 2 Drug drug interactionExperimental Treatment2 Interventions

Group II: ODM-208 Part 2 Dose expansionExperimental Treatment1 Intervention

Group III: ODM-208 Part 1 Dose escalationExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Midazolam

2018

Completed Phase 4

~1910

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Orion Corporation, Orion PharmaLead Sponsor

137 Previous Clinical Trials

44,720 Total Patients Enrolled

5 Trials studying Prostate Cancer

407 Patients Enrolled for Prostate Cancer

Karim FizaziPrincipal InvestigatorGustave Roussy, Cancer Campus, Grand Paris

3 Previous Clinical Trials

235 Total Patients Enrolled

3 Trials studying Prostate Cancer

235 Patients Enrolled for Prostate Cancer

Media Library

ODM-208 (Androgen Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03436485 — Phase 1 & 2

Prostate Cancer Research Study Groups: ODM-208 Part 2 Drug drug interaction, ODM-208 Part 2 Dose expansion, ODM-208 Part 1 Dose escalation

Prostate Cancer Clinical Trial 2023: ODM-208 Highlights & Side Effects. Trial Name: NCT03436485 — Phase 1 & 2

ODM-208 (Androgen Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03436485 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there remaining vacancies for this research program?

"Clinicaltrials.gov records demonstrate that, while this particular trial is not presently enrolling patients, the initial post date was 3/19/2018 and it was updated on 11/11/2022. Despite this clinical study's status, there are 1,258 other trials actively seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer

2018. "Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03436485.

All > Prostate Cancer Baltimore