204 Participants Needed

ODM-208 for Prostate Cancer

(CYPIDES Trial)

Recruiting at 19 trial locations
OC
OC
Overseen ByOrion Corporation, CSD
Age: 18+
Sex: Male
Trial Phase: Phase 1 & 2
Sponsor: Orion Corporation, Orion Pharma
Must be taking: GnRH analogue
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of this first-in-man study is to evaluate safety and tolerability of ODM-208 in patients with metastatic castration-resistant prostate cancer.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, ongoing androgen deprivation therapy is required, so you should continue with that treatment.

What data supports the effectiveness of the drug ODM-208 for prostate cancer?

The research on ODM-201, a similar drug, shows it effectively blocks the growth of prostate cancer cells by targeting the androgen receptor, which is crucial for cancer growth. This suggests that ODM-208 might also be effective in treating prostate cancer by similar mechanisms.12345

Is ODM-208 safe for humans?

The safety of ODM-208 specifically isn't detailed, but a similar drug, ODM-201, showed a favorable safety profile in trials for prostate cancer, meaning it was generally well-tolerated by patients.12345

Research Team

KF

Karim Fizazi

Principal Investigator

Gustave Roussy, Cancer Campus, Grand Paris

Eligibility Criteria

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.

Inclusion Criteria

I am currently on hormone therapy for cancer or have had both testicles removed.
My blood, liver, and kidney tests are within normal ranges.
My cancer has spread to other parts of my body.
See 10 more

Exclusion Criteria

I do not have any active heart or brain blood vessel problems.
I have a condition or infection that makes taking steroids unsafe.
I have brain metastases or active leptomeningeal disease.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ODM-208 to evaluate safety and tolerability

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • ODM-208
Trial OverviewThe 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Orion Corporation, Orion Pharma

Lead Sponsor

Trials
140
Recruited
45,200+
Liisa Hurme profile image

Liisa Hurme

Orion Corporation, Orion Pharma

Chief Executive Officer since 2022

PhD in Biochemistry, University of Helsinki

Hilpi Rautelin profile image

Hilpi Rautelin

Orion Corporation, Orion Pharma

Chief Medical Officer since 2023

MD, University of Turku

Findings from Research

ODM-201, an androgen receptor inhibitor, was found to be safe and well-tolerated in men with metastatic castration-resistant prostate cancer, with no dose-limiting toxic effects reported during the trial involving 24 patients in phase 1.
At 12 weeks, 29% to 33% of patients across different dosage groups (200 mg, 400 mg, and 1400 mg) showed a significant PSA response, indicating that ODM-201 effectively suppresses disease progression.
Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial.Fizazi, K., Massard, C., Bono, P., et al.[2017]
ODM-201, a second-generation androgen receptor inhibitor, demonstrated similar pharmacokinetics between its tablet and capsule formulations, indicating that the tablet can be effectively used in treatment.
In a trial with 30 chemotherapy-naive men with metastatic castration-resistant prostate cancer, 83% showed a significant PSA response (≥50% reduction), and the treatment was well tolerated, with common side effects being fatigue and nausea.
Pharmacokinetics, Antitumor Activity, and Safety of ODM-201 in Patients with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer: An Open-label Phase 1 Study.Massard, C., Penttinen, HM., Vjaters, E., et al.[2018]
In the ARADES trial involving 134 patients with castration-resistant prostate cancer (CRPC), prolonged treatment with the androgen receptor antagonist ODM-201 was well tolerated, showing a consistent safety profile with no unexpected adverse effects over an average treatment duration of 8.2 months.
Patients who had not previously undergone chemotherapy experienced significantly longer median times to PSA progression (25.2 months) and radiographic progression (14.0 months) compared to those who had been pretreated, suggesting that ODM-201 may be particularly effective in chemotherapy-naïve patients.
Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Castration-resistant, CYP17 Inhibitor-naïve Prostate Cancer: Results from Extended Follow-up of the ARADES Trial.Fizazi, K., Massard, C., Bono, P., et al.[2019]

References

Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial. [2017]
Pharmacokinetics, Antitumor Activity, and Safety of ODM-201 in Patients with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer: An Open-label Phase 1 Study. [2018]
Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Castration-resistant, CYP17 Inhibitor-naïve Prostate Cancer: Results from Extended Follow-up of the ARADES Trial. [2019]
Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naïve and CYP17 Inhibitor-naïve Patients: Follow-up from the ARADES and ARAFOR Trials. [2019]
Discovery of ODM-201, a new-generation androgen receptor inhibitor targeting resistance mechanisms to androgen signaling-directed prostate cancer therapies. [2018]