Clinical trial NCT03436485: Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer
Official title: Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer Metastatic
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2018-02-19
Enrollment: 204
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 and tolerability of ODM-208 in patients with metastatic castration-resistant prostate cancer.

Detailed description: Safety and tolerability profile of ODM-208 will be explored

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum tolerated dose (MTD)
timeFrame: Within first 28 days of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Marlene and Stewart Greenebaum Cancer Center
state: Maryland
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Buffalo
country: United States
facility: University at Buffalo, Kaleida Health Great Lakes Cancer Care Collaborative
state: New York
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Bordeaux
country: France
facility: Institute Bergonié
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institute Paoli-Calmettes
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe
city: Suresnes
country: France
facility: Hopital Foch
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Bedlington
country: United Kingdom
facility: The Rutherford Cancer Centre, North East
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre
city: Liverpool
country: United Kingdom
facility: The Rutherford Cancer Centre, North West
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Karim Fizazi
role: PRINCIPAL_INVESTIGATOR
References: