Clinical trial NCT02344017: Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2015-01-22
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The safety profile of ODM-204 will be explored together with the pharmacokinetics, pharmacodynamics and tumour response to treatment with ODM-204 to recommend the dosing regimen for further clinical studies. The pharmacokinetic properties of ODM-204 will be evaluated after single and multiple dose administrations at different dose levels.

Eligibility 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

Primary outcomes:
measure: Safety and tolerability assessed by incidence of adverse events
timeFrame: Until disease progression, an expected average of 6 months
measure: Safety and tolerability assessed by vitals signs and 12-lead ECG
timeFrame: Until disease progression, an expected average of 6 months
measure: Safety and tolerability assessed by laboratory assessments
timeFrame: Until disease progression, an expected average of 6 months
Secondary outcomes:
measure: Pharmacokinetic profile assessed by plasma peak concentration (Cmax)
timeFrame: 0 - week 12
measure: Pharmacokinetic profile assessed by area under the concentration-time curve (AUC)
timeFrame: 0 - week 12
measure: Pharmacokinetic profile assessed by time to reach peak concentration (tmax)
timeFrame: 0 - week 12
measure: Preliminary antitumour activity assessed by prostate specific antigen (PSA) response
timeFrame: Until disease progression, an expected average of 6 months
measure: Preliminary antitumour activity assessed by response in soft and bone tissues
timeFrame: Until disease progression, an expected average of 6 months
measure: Pharmacodynamic profile assessed by hormone and circulating tumour cell measurements
timeFrame: 0 - week 12
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Riga
country: Latvia
facility: P. Stradins Clinical University Hospital
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Karim Fizazi
role: PRINCIPAL_INVESTIGATOR
References: