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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 February 2024 |
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Main ID: |
NCT03436485 |
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Date of registration:
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12/02/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer
CYPIDES |
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Scientific title:
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Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer |
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Date of first enrolment:
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March 19, 2018 |
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Target sample size:
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204 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03436485 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Finland
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France
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United Kingdom
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United States
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Contacts
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Name:
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Karim Fizazi |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gustave Roussy, Cancer Campus, Grand Paris |
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Key inclusion & exclusion criteria
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Main Inclusion Criteria:
- Written informed consent (IC) obtained.
- Male aged = 18 years.
- Histologically confirmed adenocarcinoma of the prostate.
- Castration resistant prostate cancer with serum testosterone < 50 ng/dl.
- Metastatic disease.
- Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had
bilateral orchiectomy.
- Received at least one prior line of novel hormonal androgen receptor (AR) targeted
therapy (e.g. abiraterone, enzalutamide).
- ECOG performance status 0-1.
- Adequate marrow, liver and kidney function.
- Able to swallow study treatment.
- Part 1: Treatment with at least 1 line of chemotherapy or ineligibility for
chemotherapy. Part 2: Treatment with at least 1 line of taxane-based chemotherapy in
castration-sensitive prostate cancer (CSPC) or in CRPC.
Main Exclusion Criteria:
- History of pituitary or adrenal dysfunction.
- Known brain metastases or active leptomeningeal disease.
- Active infection or other medical condition that would make corticosteroid
contraindicated.
- Poorly controlled diabetes.
- Hypotension or uncontrolled hypertension.
- Clinically significantly abnormal serum potassium or sodium level.
- Active or unstable cardio/cerebro-vascular disease including thromboembolic events.
- Prolonged QTcF interval.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer Metastatic
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Intervention(s)
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Drug: Midazolam
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Drug: ODM-208
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Primary Outcome(s)
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Maximum tolerated dose (MTD)
[Time Frame: Within first 28 days of treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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