Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02344017
• Date of registration: 29/12/2014
• Prospective Registration: Yes
• Primary sponsor: Orion Corporation, Orion Pharma
• Public title: Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer DUALIDES
• Scientific title: 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
• Date of first enrolment: February 2015
• Target sample size: 23
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02344017
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Finland, France, Latvia, United Kingdom

Contacts

• Name: Karim Fizazi
• Affiliation: Gustave Roussy, Cancer Campus, Grand Paris

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Drug: ODM-204

Drug: Prednisone

Primary Outcome(s)

Safety and tolerability assessed by incidence of adverse events [Time Frame: Until disease progression, an expected average of 6 months]

Safety and tolerability assessed by laboratory assessments [Time Frame: Until disease progression, an expected average of 6 months]

Safety and tolerability assessed by vitals signs and 12-lead ECG [Time Frame: Until disease progression, an expected average of 6 months]

Secondary Outcome(s)

Preliminary antitumour activity assessed by response in soft and bone tissues [Time Frame: Until disease progression, an expected average of 6 months]

Pharmacokinetic profile assessed by plasma peak concentration (Cmax) [Time Frame: 0 - week 12]

Preliminary antitumour activity assessed by prostate specific antigen (PSA) response [Time Frame: Until disease progression, an expected average of 6 months]

Pharmacodynamic profile assessed by hormone and circulating tumour cell measurements [Time Frame: 0 - week 12]

Pharmacokinetic profile assessed by area under the concentration-time curve (AUC) [Time Frame: 0 - week 12]

Pharmacokinetic profile assessed by time to reach peak concentration (tmax) [Time Frame: 0 - week 12]

Secondary ID(s)

3116001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors