Clinical trial · Interventional
Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer
Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC): Open, Non-Randomised, Uncontrolled, Multicentre, Dose Escalation, First-in-man Study With a Dose Expansion
NCT02344017CI-TRIAL-00042423DUALIDEScompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this first-in-man study is to evaluate safety, tolerability and pharmacokinetics of ODM-204 in patients with metastatic castration-resistant prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ODM-204 | Drug | — | UNRESOLVED |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ODM-204 Phase I dose escalation
- description
- Dose escalation
- interventionNames
- Drug: ODM-204
- Drug: Prednisone
- type
- EXPERIMENTAL
- label
- ODM-204 Phase II dose expansion
- interventionNames
- Drug: ODM-204
- Drug: Prednisone
Primary outcomes (3)
- measure
- Safety and tolerability assessed by incidence of adverse events
- timeFrame
- Until disease progression, an expected average of 6 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent (IC) obtained. * Male aged ≥ 18 years. * Histologically or cytologically confirmed adenocarcinoma of prostate. * Ongoing GnRH agonist or antagonist therapy, or after bilateral orchiectomy. * Progressive metastatic disease * Adequate bone marrow, hepatic, and renal function * Acceptable and regular bowel movements without any GI disorder or procedure which may interfere with absorption of study treatment * Ability to swallow study treatments Exclusion Criteria: * History of pituitary or adrenal dysfunction. * Known brain metastases. * Active infection or other medical condition that would make prednisone (corticosteroid) contraindicated. * Uncontrolled hypertension * Clinically significant heart disease * Prolonged QTc interval
References
Publications (0)
Data not yet available
No reference posted for this study.